[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Shoulder pain excaberated by resisted movement. Painful arch. Symptoms for less than 3 months.
Excluded criteria: Systemic inflammatory arthropathy. Drop arm sign. Peptic ulcer. Injection within 3 months. Arthritis, GH or AC.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, Mean change, SEM
Funktion, limitation in function, mean change, SEM
Alvorlige bivirkninger (SAE) n/N
Bivirknigner (AE) n/N
Sponsorship source: Not stated
Country: UK
Setting: Outpatient rheumatology clinick
Authors name: A.O. Abdebajo
Institution: Rheumatology Research Unit
Email: Not stated
Address: Addenbrooke's Hospital, Cambridge, CB2 2QQ, UK
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients with (i) a history of posterolateral shoulder pain for more than three months which increased on shoulder abduction; (ii) painful restriction of active flexion and/or abduction of the shoulder with more restriction on passive ROM; (iii) a positive Hawkins-Kennedy impingement sign;[12] and (iv) magnetic resonance imaging (MRI) consistent with SIS (rotator cuff impingement) were included in the study. Magnetic resonance imaging criteria for SIS included: signal intensity changesin tendons suggestive of tendinosis, acromial spur indentation without microstructural changes of rotator cuff muscles and tendons and disappearance of the subacromial fat in coronal plane T1 weighted images
Excluded criteria: Exclusion criteria included (i) a history of inflammatory arthritis; (ii) erythema/swelling of the shoulder joint; (iii) neurological deficit of the upper extremities; (iv) shoulder dislocation; (v) presence of partial/full thickness rotator cuff tear, bursitis, calcific tendinitis, or labral tears on MRI; (vi) significant chronic disease; (vii) a history of or current malignancy; (viii) shoulder trauma occurring within the past three months; (ix) SIS treatment within the past three months; (x) physical therapy of the ipsilateral shoulder within the past six months; (xi) non-consent to subacromial injection; (xii) cases in which surgical intervention was deemed to be the appropriate treatment of choice; (xiii) cervical disc/suspicion of a cervical disc pathology; or (xiv) pregnancy and breastfeeding.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, median (min max)
Funktion (function) Constant Score, median (min max)
Funktion (function) DASH, median (min max)
Funktion (function) Constant score, mean, SD
Alvorlige bivirkninger (SAE)
Bivirkninger (AE)
Sponsorship source: This study was supported by the Baskent University Research Fund.
Country: Turkey
Setting: Outpatient clinic
Authors name: Selin Ozen
Institution: Department of Physical and Rehabilitation Medicine, Başkent University Faculty of Medicine, Ankara, Turkey
Email: selinhassan@hotmail.com
Address: Başkent Üniversitesi Tıp Fakültesi Fiziksel Tıp ve Rehabilitasyon Anabilim Dalı, 06490 Bahçelievler, Ankara, Türkiye
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Unilateral shoulder pain and diagnosed as having stage 2 SIS. Diagnosis was based on history, clinical examination, conventional radiography, subacromial injection test and magnetic resonance imaging (MRI). The patients with positive impingement tests (Neer, Hawkins Kennedy and painful arc tests) and positive subacromial injection test were diagnosed as having shoulder impignement syndrome.
Excluded criteria: The patients who had: (1) other concomitant shoulder pathologies such as adhesive capsulitis, calcific tendinitis, dislocations, etc., (2) cervical pain or other painful conditions such as fibromyalgia conflicting the clinical picture, (3) any local or systemic contraindication for corticosteroid use such as infection, diabetes, hypertension, etc., (4) history of gastritis or peptic ulcer that may causecomplications with NSAID use, (5) prior applicationsof any treatment modality such as physiotherapy, corticosteroid injections and NSAID during the preceding 3 months were excluded from the study.
Intervention Characteristics
Intervention
Control
Smerte (pain at rest) VAS 0-10, Mean change, SD
Smerte (pain on activity) VAS 0-10, Mean change, SD
Funktion, Constant score total, mean, SD
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated.
Country: Turkey
Authors name: M. Birtane
Institution: Physical Medicine and Rehabilitation Department, Faculty of Medicine, Trakya University
Email: mbirtane@hotmail.com
Address: Kocasinan Mah. 18. Sok., Bora Apt. A blok D: 13, Edirne, Turkey
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Unilateral shoulder pain and diagnosed as having stage 2 SIS. Diagnosis was based on history, clinical examination, conventional radiography, subacromial injection test and magnetic resonance imaging (MRI). The patients with positive impingement tests (Neer, Hawkins Kennedy and painful arc tests) and positive subacromial injection test were diagnosed as having shoulder impignement syndrome.
Excluded criteria: The patients who had: (1) other concomitant shoulder pathologies such as adhesive capsulitis, calcific tendinitis, dislocations, etc., (2) cervical pain or other painful conditions such as fibromyalgia conflicting the clinical picture, (3) any local or systemic contraindication for corticosteroid use such as infection, diabetes, hypertension, etc., (4) history of gastritis or peptic ulcer that may causecomplications with NSAID use, (5) prior applicationsof any treatment modality such as physiotherapy, corticosteroid injections and NSAID during the preceding 3 months were excluded from the study.
Intervention Characteristics
Intervention
Control
Smerte (pain at rest) VAS 0-10, Mean change, SD
Smerte (pain on activity) VAS 0-10, Mean change, SD
Funktion, Constant score total, mean, SD
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated.
Country: Turkey
Authors name: M. Birtane
Institution: Physical Medicine and Rehabilitation Department, Faculty of Medicine, Trakya University
Email: mbirtane@hotmail.com
Address: Kocasinan Mah. 18. Sok., Bora Apt. A blok D: 13, Edirne, Turkey
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients with rotator cuff tendinosis or partial cuff tear with symptoms longer than 6 months, with failure of 6 weeksof physical therapy and 2 weeks of nonsteroidal anti-inflammatory drugs, who were older than 30 years of age, and who showed>50% improvement with the Neer impingement test were stratified for Workplace Safety and Insurance Board status and previous injection.
Excluded criteria: Not stated.
Intervention Characteristics
Intervention
Control
Funktion, ASES score, mean SD
Funktion, DASH, mean SD
Livskvalitet, WORC, mean, SD
Sponsorship source: Not stated
Country: Canada
Setting: Not stated
Authors name: Sharon Griffin
Institution: Fowler Kennedy Sport Medicine Clinic, 3M Centre, University of Western Ontario
Email: sharon.griffin@uwo.ca
Address: London, Ontario, N6A 3K7 Canada
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Age of at least 18 years, a painful shoulder for more than 7 days which had not improved with NSAIDs treatment, and the diagnosis of SIS defined by the compliance with the criteria for rotator cuff tendinitis proposed by the Southampton group and a positive result after undergoing the Neer test of subacromial lidocaine injection.
Excluded criteria: A hooked acromion, an acromioclavicular joint osteophite or a calcium deposit in the subacromial region present on a anteroposterior x-ray of the shoulder; subjects with a history of allergy to lidocaine, the presence of a systemic inflammatory infectious disease or uncontrolled hypertension or diabetes.
Intervention Characteristics
Intervention
Control
Smerte (pain)VAS 0-10
Funktion, Shoulder disability questionnaire (SDQ),
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: Mexico
Setting: Department of rheumatology and orthopedics
Authors name: José Álvarez-Nemegyei
Institution: Unidad de Investigación Médica, Unidad Médica de Alta Especialidad #25, Instituto Mexicano del Seguro Social
Email: nemegyei@yahoo.com.mx
Address: Mérida, Yucatán, Mexico
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: We included patients who were at least 18 years old with following features: History of shoulder pain for atleast two months that has been not satisfactorily responsive to a trial of oral medication and physical therapy for atleastlast one month, historyof night pain, pain on overhead abduction, less than 50% reduction in glenohumeral range of motion in not more than one direction of external rotation, internal rotation or abduction or positive impingement test.
Excluded criteria: We excluded patients with history of inflammatory joint disease, significant trauma, periarticular arthritis, allergy to contrast agents, previous history of steroid injection in the same shoulder. Patients with symptomatic acromioclavicular arthritis,fullthickness rotator cuff tear, pregnant patients and those who did not wish to participate in the study were also excluded.
Intervention Characteristics
Intervention
Control
smerte (pain) VAS 0-10, mean, SD
Funktion (function) Constant score, mean, SD
Alvorlige bivirkninger (SAE)
Bivirkninger (AE)
Sponsorship source: No funding
Country: India
Setting: Orthopedic outpatient clinic
Authors name: H. Bhayana
Institution: Department of Orthopaedics, GTB Hospital & UCMS
Email: Himanshu.bhayana.mamc@gmail.com
Address: Delhi 110095, India
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Included criteria: ll patients who were seen in the shoulder clinic from September 1992 to January 1993 with pain in the shoulder that was characteristic of subacromial impingement syndrome were asked to enroll in the study if they met these criteria: (1) the symptoms had lasted for at least three months, (2) a diagnosis of subacromial impingement syndrome had been made on the basis of the lidocaine injection test 23, (3) the patient had not had previous subacromial injec-tions of corticosteroids, (4) there was no evidence of os acromiale on plain radiographs, (5) the patient was not involved in a Workers' Compensation claim related to the shoulder, and (6) there was no clinical or radio-graphic evidence of a full-thickness tear of the rotator cuff.
Excluded criteria: To identify and exclude patients who had a tear of the rotator cuff, double-contrast arthrography or mag-netic resonance imaging was performed for all patients who had signs of muscular atrophy and weakness on forward elevation or external rotation after subacromial injection of lidocaine as well as for all patients who were more than sixty years old.
Intervention Characteristics
Intervention
Control
Intervention 2
Description:
Control 2
No outcome for out timeframe of interest. The study reports results for a mean duration of 33 weeks ( rrange 12-52) our timeframe of interest was 1 months after the first injection.
Sponsorship source: No funds were received in support of this study
Country: USA
Setting: The shoulder Institute, the Hospital for Joint Deseases, New York City
Authors name: Benjamin Blair
Institution: Department of Orthopedic Surgery, the Hospital for Joint Deseases, New York City
Email: Not stated
Address: Department of Orthopedic Surgery, the Hospital for Joint Deseases, 301 east 17th Street, New York, N.Y. 10003
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
mean age in years (range): 50 (31-68)
Included criteria: (i) age between 30-70; (ii) without sports events; (iii) complains for six months or more; (iv) determination of impingement symptom in the clinical examination (Neer impingement test, Hawkins sign, Jobe supraspinatus test) , having less than 10 % stifness compared to other side in the passive range of motion; (v) lack of deformities such as degenerative arthritis , mezoacromion under the anterior- posterior X-ray examination; (vi) no pathologic symptom other than inflamation in the subacromial bursa after the examination of magnetic resonance.
Excluded criteria: The patients who had shoulder operation or physical therapy and rehabilitation program, who had rotator cuff lesion or pathologic symptom in radiographies and who were under psychiatric treatment were not selected for this study.
Intervention Characteristics
Intervention
Control
Smerte (pain at rest) VAS 0-10, mean SD
Funktion, Constant score total, mean, SD
Sponsorship source: Not stated
Country: Turkey
Setting: Orthopedic clinic for shoulder surgery
Authors name: Derya Çelik.Istanbul University
Institution: Istanbul Faculty of Medicine, Department of Orthopaedics and Traumatology
Email: deryacavga@hotmail.com
Address: 34093 Çapa, İstanbul.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: A history of shoulder pain with overhead activities and clinical signs of impingement (either in internal rotation or external rotation), with an absence of rotator cuff tears, osteoarthritis, and adhesive capsulitis. To evaluate their existing pathological abnormalities and exclude any cause of pain other than subacromial impingement syndrome
Excluded criteria: Excluded if they had undergone previous surgery of the affected shoulder or had rotator cuff tears, calcific tendinitis, adhesive capsulitis, inflammatory arthritis, acromioclavicular joint pain, os acromiale, osteoarthritis, fractures, bone tumors, osteonecrosis, or other bone conditions seen on radiographs.
Intervention Characteristics
Intervention
Control
Smerte (pain overhead activities) VAS 0-100, mean, SEM
Funktion, ASES score, mean SD
Sponsorship source: Not stated
Country: Australia
Authors name: George A.C. Murrell
Institution: Orthopaedic Research Institute
Email: murrell.g@ori.org.au
Address: St George Hospital, 4-10 Short Street, Kogarah NSW 2217, Sydney, Australia
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Aged 40 and older, unilateral shoulder pain, subjectively rate their pain as moderate or severe on a 3 point scale (mild/moderate/severe), and have a non-capsular pattern of restriction. Capsular pattern was defined as painful and limited passive glenohumeral mobility, with lateral rotation relatively more restricted than abduction andmedial rotation. Some loss of lateral rotation was permitted but no more than 25% compared with opposite side. Participants also had to show a Neer impingement sign (passive shoulder elevation with scapular fixed) or have positive results on the Hawkins impingement test (shoulder elevation to 90°, elbow flexed to 90°, then passively internally rotate the humerus).
Excluded criteria: Exclusion criteria were known blood coagulation disorders; evidence of referred pain from the cervical spine or internal organs; history of rheumatoid arthritis, polymyalgia rheumatica, or other inflammatory arthritis; bilateral shoulder pain; neurological diagnosis such as cerebrovascular event with shoulder involvement; contraindication to steroid-lidocaine injection; pregnancy or breast feeding; previous fracture, dislocation, or surgery to shoulder, upper limb, neck, or thorax; steroid injections or physiotherapy for the symptomatic shoulder within the previous six months; or inability to provide informed consent.
Intervention Characteristics
Intervention
Control
Smerte (SPADI pain), mean change, 95% CI
Funktion, SPADI total, mean change, 95% CI
Funktion, SPADI disability, mean change, 95% CI
Adherencer til trćning n/N
Alvorlige bivirkninger (SAE) n/N
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: The study was funded by a project grant 17236 Arthritis Research
Country: UK
Setting: Arthritis Research
Authors name: Dickon P Crawshaw
Institution: Leeds Musculoskeletal and Rehabilitation Service, Leeds Community Healthcare
Email: p.conaghan@leeds.ac.uk
Address: Leeds LS7 4SA UK
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients diagnosed with SIS who had shoulder pain for at least 3 mos were included in this study. The diagnoses were based on history, clinical examinations, and magnetic resonance imaging. To assess SIS, three provocative tests were performed: Neer,Hawkins, and Jobe’s ‘‘Empty Can’’ tests.
Excluded criteria: Exclusion criteria were evidence of another pathology that could cause shoulder pain, such as adhesive capsulitis or calcific tendinitis; dislocations; chronic inflammatory arthritis; detection of full-thickness tears or total rupture and labral tears on MRI; previous applications of any treatment modality such as physiotherapy and corticosteroid injections; use of regular systemic nonsteroidal antiinflammatory drugs or corticosteroids; and presence of cervical pain or other painful conditions such asfibromyalgia and polymyalgia rheumatica.
Intervention Characteristics
Intervention
Control
Smerte (pain at rest) VAS 0-10, mean SD
Smerte (pain on activity) VAS 0-10, mean SD
Smerte (Constant pain at rest), mean SD
Funktion, Shoulder disability questionnaire (SDQ), mean, SD
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: Turkey
Comments: "Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article."
Authors name: Beril Dogu
Institution: Department of Physical andRehabilitation Medicine
Email: Not stated
Address: S¸ is¸li Etfal Eg˘itim ve Aras¸tırma Hastanesi 34377, S¸ is¸li, Istanbul, Turkey
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: 1) Posterolateral shoulder pain, 2) Pain in abduction orpainful restriction of glenohumeral mobility, 3) provocation of symptoms by Neer and Hawkins tests.
Excluded criteria: Exclusion criteria were as follows: shoulder pain due to osseous pathology (e.g. osteoarthritis, osteonecrosis), duration of shoulder pain more than three months, previous trauma in the shoulder region, previous physiotherapy or local steroid injection in last three months, any evidence of predisposing condition such as diabetes mellitus, rheumatoid arthritis, hypothyroidism and unwillingness to participate in the present study.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, Mean, SD
Smerte (SPADI pain), mean, SD
Funktion (function) SPADI disability, mean, SD
Sponsorship source: Not stated
Country: Iran
Setting: Physical Medicine and Rehabilitation outpatient clinics
Authors name: Parisa Taheri
Institution: Department of Physical Medicine and Rehabilitation, University of Isfahan Medical Sciences
Email: Prs_taheri@yahoo.com
Address: Isfahan, Iran
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Intervention 2
Included criteria: Inclusion criteria were (1) participants with clinically diagnosed periarticular disorder of the shoulder (impingement syndrome, rotator cuff lesions, subacromial-subdeltoid bursitis, and/or biceps tendon abnormalities) (2) participants aged 20 to 70 years, (3) a first flare of shoulder pain of periarticular cause, (4) at least 1 month’s duration, and (5) pain of moderate to severe intensity, defined as a score of 3 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain).
Excluded criteria: Exclusion criteria were (1) current adhesive capsulitis (normal radiograph of affected shoulder, restriction of passive motion 30° in 2 planes of movement, measured to onset of pain by using a gravity inclinometer)30; (2) full-thickness tear in ultrasound examination; (3) presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (ie, diabetes), major depression, or schizophrenia; (4) previous trauma history at currently affected shoulder; (5) primary osteoarthritis of the glenohumeral joint in a simple radiograph; (6) previous corticosteroid injection history at the affected shoulder; and (7) use of medication such as antiplatelet agent or anticoagulation.
Intervention Characteristics
Intervention
Control
Intervention 2
Smerte (pain) VAS 0-10, Mean, SD
Funktion, Shoulder disability questionnaire (SDQ), mean, SD
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.
Country: Korea
Setting: Department of Physical Medicine and Rehabilitation
Authors name: Seung-Hyun Yoon
Institution: Department of Physical Medicine and Rehabilitation, Ajou University School of Medicine and Ajou University Hospital
Email: yoonsh@ajou.ac.kr
Address: San 5, Wonchon-dong, Yeongtong-gu, Suwon 443-721, Republic of Korea
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: (a) shoulder pain for more than 1 month, (b) painful abduction with a visual analog scale (VAS) score for pain Q 4, (c) the presence of a painful arc of motion or pain at the mid- to terminal range of shoulder abduction or internal rotation and a soft end feel, (d) tenderness over the subacromial bursa, and (e) a reduction in pain of over 40% on active shoulder abduction at the terminal range after the injection of 3 mL of 1% lidocaine into the subacromial bursa
Excluded criteria: (a) a history of uncontrolled chronic diseases, for example, malignant neoplasms, hypocoagulability, and infection; (b) previoussurgery of the affected shoulder; (c) any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests or sonographic findings; (d) calcification of the rotator cuff, demonstrated by x-ray or sonographic findings; (e) the presence of arthritis, such as inflammatory arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathy, and crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion; (f ) the presence of instability of the affected shoulder; (g) a previous fracture near the shoulder region; (h) the presence of cervical radiculopathy or myelopathy; and (i) having received a corticosteroid or hyaluronate subacromial or shoulder joint injection in the past 3 months.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, Mean, SD
Smerte (SPADI pain), mean, SD
Funktion, SPADI total, mean SD
Funktion, SPADI disability, mean, SD
Funktion, Shoulder disability questionnaire (SDQ), mean, SD
Livskvalitet, SF 36, social functioning, mean, SD
Livskvalitet, SF 36, physical role, mean, SD
Livskvalitet, SF 36, bodily pain, mean, SD
Livskvalitet, SF 36, general health, mean, SD
Livskvalitet, SF 36, vitality, mean, SD
Livskvalitet, SF 36, physical functioning, mean, SD
Livskvalitet, SF 36, emotional role, mean, SD
Livskvalitet, SF 36, mental health, mean, SD
Sponsorship source: The authors acknowledge the financial support provided by the Shin Kong Wu Ho-Su Memorial Hospital.
Country: Taiwan
Setting: Department of Physical Medicine and Rehabilitation
Authors name: Lin-Fen Hsieh
Institution: Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, No. 95
Email: M001026@ms.skh.org.tw; reh6110@yahoo.com.tw
Address: Wen Chang Road, Shin Lin District, Taipei 111, Taiwan
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients referred to our rheumatology department with a first flare of shoulder pain of periarticular etiology, at least one month of duration, without response to nonsteroidal antiinflammatory drugs (NSAID). Periarticular disorders of the shoulder included impingement syndrome, rotator cuff lesions, subacromial-subdeltoid bursitis, and/or biceps tendon abnormalities.
Excluded criteria: Patients with chronic inflammatory arthritis and previous trauma were excluded. No patient had received previous physiotherapy or local steroid injection in the shoulder.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-100, Mean change, SD
Funktion, SFA, mean change, SD
Bivirkninger (SAE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: Spain
Setting: Rheumatolog department
Authors name: Dr. E. Naredo
Institution: Department of Rheumatology, the Research Unit, and the Epidemiology Unit, Severo Ochoa Hospital, Madrid, Spain
Email: esnaredo@eresmas.com
Address: Calle Arturo Soria 259, 4ş A, 28033 Madrid, Spain
Indirectness: En del patienter har ikke SAPS, men bicepspatologi og calcificerende tendinit
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Eligible patients were over 18 years of age and had pain in the shoulder, either at rest or on movement. The diagnosis of impingement was made clinically without the routine use of ultrasound. All presented with a painful arc, with or without abnormal scapulohumeral movement.
Excluded criteria: Exclusion criteria included: pain for less than six weeks; injection with corticosteroids in the preceding three months; flexion of < 100° in the frontal plane; external rotation limited by > 50% compared with the opposite side; allergy to lidocaine, steroids or hyaluronic acid; pregnancy or suspected pregnancy; dementia; prior infection of the shoulder joints; tumour; osteoporosis; rheumatoid arthritis; referred pain, such as from the neck; an associated neurological disorder; polymyalgia; ankylosingspondylitis; whiplash injury; previous fractures or surgery on the shoulder, upper limb, neck or thorax; and behavioural, cognitive or psychiatric disorders. Patients unable to complete Dutch questionnaires independently or reluctant to adhere to the allocated treatment or to complete follow-up were also excluded.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, Mean, 95% CI
Funktion, Constant score total, mean, 95 % CI
Funktion, Shoulder disability questionnaire (SDQ), mean, SD
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: The Netherlands
Authors name: Ludo IF Penning
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Criteria for entry into the study were the presence of at least 2 of the following 3 findings: painful abduction at any degree ofmotion, painful arc of movement from 45” to 120°, or tenderness over the insertion of the supraspinatus tendon. Biceps tendinitis was not an inclusion criterion
Excluded criteria: Patients were excluded for any of the following: significant glenohumeral arthritis, a supraspinatus injection during the preceding 3 months, a reason to suspect rotator cuff tear (weakness of arm elevation, a positive “drop arm sign,” or a high-riding humerus visible on roentgenogram of the shoulder), contraindication to the use of NSAIDs (e.g., allergy, renal insufficiency, gastritis, or ulcer), or an allergy to lidocaine.
Intervention Characteristics
Intervention
Control
Intervention 2
Control 2
Smerte (pain) 0-5, Mean change, SEM
Funktion, clinical index, mean change, SEM
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: USA
Authors name: Michelle Petri
Institution: Halsted 148, Johns Hopkins Hospital, 600 N.
Email: Not stated
Address: Wolfe Street, Baltimore, MD 21205.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Criteria for entry into the study were the presence of at least 2 of the following 3 findings: painful abduction at any degree ofmotion, painful arc of movement from 45” to 120°, or tenderness over the insertion of the supraspinatus tendon. Biceps tendinitis was not an inclusion criterion
Excluded criteria: Patients were excluded for any of the following: significant glenohumeral arthritis, a supraspinatus injection during the preceding 3 months, a reason to suspect rotator cuff tear (weakness of arm elevation, a positive “drop arm sign,” or a high-riding humerus visible on roentgenogram of the shoulder), contraindication to the use of NSAIDs (e.g., allergy, renal insufficiency, gastritis, or ulcer), or an allergy to lidocaine.
Intervention Characteristics
Intervention
Control
Intervention 2
Control 2
Smerte (pain) 0-5, Mean change, SEM
Funktion, clinical index, mean change, SEM
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: USA
Authors name: Michelle Petri
Institution: Halsted 148, Johns Hopkins Hospital, 600 N.
Email: Not stated
Address: Wolfe Street, Baltimore, MD 21205.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Shoulder pain of at least 3-month duration with minimal or no response to non-steroidal anti-inflammatorydrugs (NSAIDs). Plain radiographs of the shoulder were obtained for all patients to exclude fracture, glenohumeral osteoarthritis,chronic inflammatory arthritis, bone tumours, osteonecrosis and other bone conditions.
Excluded criteria: Patients who had clinical and radiological findings indicating moderate osteoarthritis, referred pain from the neck or internal organs and generalized muscular pain syndrome with bilateral muscular pain in the neck and shoulders, a history of inflammatory arthritis, previous fractures or surgery to the shoulder, or contraindications to local steroid injections were excluded. Patients who had been treated with local corticosteroid injections and/or physiotherapy within 1 month of studyinitiation were excluded.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, Mean, SD
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: Ireland
Setting: Rheumatology outpatient clinic
Authors name: A. Saeed
Institution: Department of Rheumatology, Adelaide and Meath Hospital
Email: modelian@gmail.com
Address: Tallaght, Dublin 24, Ireland
Study design: Randomized controlled trial
Study grouping: Parallel group
Intervention Characteristics
Intervention
Control
No usable dsta for our outcome of interest
Sponsorship source: Not stated
Country: Germany
Authors name: G Strřbel
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients with shoulder pain for at least 1 month and not satisfactorily responding to at least 1 month of nonsteroidal antiinflammatory drugs treatment were included.
Excluded criteria: Patients with chronic inflammatory arthritis (ie, rheumatoid arthritis, anklyosing spondilitis), diabetes mellitus, previously majortrauma in shoulder area, pain in both shoulders, or who had received previous physical therapy or local CS injections were excluded.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-10, Mean, SD
Smerte (pain at rest) VAS 0-10, mean SD
Funktion, Constant score total, mean, SD
Bivirkninger (AE) n/N
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: Turkey
Setting: Outpatient clinic
Authors name: Erhan C¸apkin
Institution: Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Karadeniz Technical University, Farabi Hospita
Email: drcapkin@yahoo.com
Address: Trabzon 61080, Turkey
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Those with clinically defined RCT i.e. shoulder pain exacerbated by movement against resistance in at least one of abduction, external rotation or internal rotation; passive range of movement remained approximately normal if the active range was limited by pain), of less than 12 weeks' duration were asked for informed consent to participate in the trial.
Excluded criteria: Patients with frozen shoulder, clinical rotator cuff tears (i.e. weak arm elevation, positive 'drop arm sign'), bicipital tendinitis (anterior shoulder pain with negative Yergason's and Speed's tests) or acromioclavicular arthritis, diagnosed in the presence of localized pain and tenderness, exacerbation with AC joint stressing manoeuvres and a high arc of pain on abduction were excluded.
Intervention Characteristics
Intervention
Control
Smerte (pain) VAS 0-30 (pain at rest,on activity and during night, 0-10 for each), median change, IQR
Sponsorship source: Not stated
Country: UK
Setting: Primary health care centre
Authors name: P. C VECCHIO
Institution: Rheumatology Research Unit, Addenbrooke's Hospital
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients presenting with supraspinatus tendonitis who were willing to accept the protocol were entered in the trial. Supraspinatus tendonitis was defined as a clinical entity of tenderness over the supraspinatus tendon, pain on resisted abduction of the glenohumeral joint in the presence of a normal passive range of glenohumeral movement.
Excluded criteria: A past history or clinical evidence of inflammatory arthritis excluded the patient from entry to the trial.
Intervention Characteristics
Intervention
Control
Intervention 2
Control 2
Smerte (pain) VAS 0-10, Mean, SD
Sponsorship source: Not stated
Country: UK
Authors name: R. H. Withrington
Institution: Department of Rheumatology, St. Mary's Hospital, London; England
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria are patients over age of 18 with shoulder pain that did not respond to NSAID or physiotherapy.
Excluded criteria: Exclusion criteria included history of inflammatory arthritis, radiological gleno-humeral osteoarthritis and previous steroid local injection within 12 weeks.
Intervention Characteristics
Intervention
Control
Smerte (pain at rest) NRS 0-10, mean , SD
Smerte (pain on activity) NRS 0-10, mean , SD
Funktion, Constant score 0-75
Alvorlige bivirkninger (SAE) n/N
Sponsorship source: Not stated
Country: Switzerland
Setting: Three rheumatology centers
Authors name: P. Zufferey
Institution: Service de rhumatologie, DAL, CHUV
Email: Pascal.zufferey@chuv.ch
Address: Avenue Pierre-Decker 4, 1011 Lausanne, Switzerland
Wrong comparator
Wrong study design
Wrong comparator
Trial protocol
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong patient population
Wrong comparator
Wrong study design
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong study design
Wrong comparator
Wrong comparator
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comment: Refers to a random number sequence
Quote: "and randomized into two groups using the Random Allocation Software version 1.0 (developed by -M. Saghaei, MD., Department of Anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran)."
Judgement Comment: Random Allocation Software version 1.0
Quote: "Patients were randomly divided into three equal groups of 16 patients in a simple systematic manner (ˇ+1) according to the therapeutic injections applied.l"
Quote: "Patients were randomly divided into three equal groups of 16 patients in a simple systematic manner (ˇ+1) according to the therapeutic injections applied.l"
Quote: "A computer-generated randomization scheme with permuted block sizes of 2 and 4 was implemented."
Quote: "The treatment assignation sequence was generated through the randomization module of the True Epistat software package."
Quote: "the patients were randomly allocated to receive US guided or LMG injection based on random number sequence."
Quote: "Patients were randomized to receive either six milliliters of 1 per cent lidocaine without epinephrine"
Judgement Comment: No information on how the allocation sequence was generated
Quote: "The patients were randomly separeted in two"
Judgement Comment: The patients were randomly allocated to injection and control groups equal in number No information on how the allocation sequence was generated.
Quote: "The patients were randomized by computer-generated ran- domization to receive either an ultrasound-guided subacro- mial injection (ultrasound group) or an unguided subacromial injection (blind group)."
Quote: "We then randomised participants to one of the two treatment groups using an independent telephone randomisation service and booked appointments to start treatment according to allocation."
Judgement Comment: Simple block randomisation was performed for seven sites based on a computer generated randomisation list.
Quote: "The patients were randomized by a random- number sequence to receive either US-guided subacro- mial injections (group 1) or blind injections (group 2)."
Judgement Comment: Participants were randomly assigned to control and case groups, two groups of 20 subjects, using randomized allocation. No information on how the allocation sequence was generated.
Quote: "were randomly assigned to 1 of 3 groups by using a block randomization method, which ensured that approximately equal numbers were allocated to each group. 32 A computerized random-number generator and table were used to perform group allocations, which were managed by an assistant (other than the authors)."
Quote: "The assignment scheme was generated using a table of computer-generated random numbers. Each patient was allocated to one of the treatment groups according to the randomization sequence."
Quote: "Patients were randomized by a random-number sequence to receive either a blind subacromial injection of 20 mg triamcinolone (Group 1, 20 patients) or a sonographic-guided injection of 20 mg triamcinolone (Group 2, 21 patients) by another independent rheumatologist experienced in US (EN), without knowledge of the clinical evaluation, within 5 days after the initial clinical evaluation."
Judgement Comment: random-number sequence.
Quote: "Patients were randomized blindly into three treatment groups. An independent statistician (FK) generated a random numbers list which, by permutation of random blocks, block size 9, was balanced for treatments within"
Judgement Comment: An independent statistician generated a random numbers list which, by permutation of random blocks, block size 9, was balanced for treatments within strata. Strata were based on age (≤40 years versus >40 years). Probably suffient method for sequence generation.
Quote: "Patients were randomized to 1 of 4 possible treat- ment groups by a random number sequence."
Judgement Comment: No information on how the allocation sequence was genrated, but probably sufficient generation since they stated that they used a random number sequnece.
Quote: "Patients were randomized to 1 of 4 possible treat- ment groups by a random number sequence."
Judgement Comment: No information on how the allocation sequence was genrated, but probably sufficient generation since they stated that they used a random number sequnece.
Quote: "a computer-generated randomization scheme with per- mitted block sizes of 2 and 4 was implemented. after the baseline registration, each participant was allocated a study number."
Judgement Comment: No information on how the allocation sequence was generated
Judgement Comment: No information on how the allocation sequence was generated.
Judgement Comment: No information on how the allocation sequence was generated.
Judgement Comment: No information on how the allocation sequence was generated.
Quote: "Patients signed an informed consent and were assigned treatment groups by random-number sequence."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: No information on how the allocation sequence was concealed
Quote: "The randomization process was conducted by a junior doctor of the PMR department who had no other involvement in the study."
Judgement Comment: No information on how the allocation sequence was concealed. Allocation sequence could be foreseen
Judgement Comment: No information on how the allocation sequence was concealed. Allocation sequence could be foreseen
Quote: "computer-generated randomization scheme with permuted block sizes of 2 and 4 was implemented. Group assignments were kept in sealed opaque envelopes"
Judgement Comment: Group assignments were kept in sealed opaque envelopes accessible only to the study nurse.
Judgement Comment: No information on how the allocation sequence was concealed
Quote: "The clinician who performed the randomisation was blinded of the clinico-radiological assessment of the patients."
Judgement Comment: No information on how the allocation sequence was concealed
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Quote: "We then randomised participants to one of the two treatment groups using an independent telephone randomisation service and booked appointments to start treatment according to allocation."
Judgement Comment: Central allocation by telephone.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: Participants were randomly assigned to control and case groups, two groups of 20 subjects, using randomized allocation. No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: Each patient was allocated to one of the treatment groups according to the randomization sequence. No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: After selection and baseline assessment, consecutive numbered opaque envelopes of the appropriate stratum were opened by one of several independent trial nurses.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Judgement Comment: No information on how the allocation sequence was concealed.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Objective outcomes: Outcome assessors were blindedSelf-reported outcomes: Patients were blinded
Quote: "All patients were screened and assessed for study participation by a single PMR specialist prior to the procedure and at four weeks post-injection. This PMR specialist was blinded to the method of injection applied and had no involvement in the injection procedure."
Judgement Comment: Patients not blinded. Most outcomes were patient reported. Patients not blinded. Most outcomes were patient reported.
Quote: "The evaluation of the patients was performed three times by another physician blinded to the content of the sub-acromial injection:"
Quote: "The evaluation of the patients was performed three times by another physician blinded to the content of the sub-acromial injection:"
Judgement Comment: Evaluator remained blinded to group assignment (we only ectracted PROMs) The study nurse, who was not involved in patient assess- ment, prepared the appropriate solutions in opaque syringes so that the study patient, clinician, and evaluator remained blinded to group assignment.Patients, clinicians and outcome assessors were blinded. Both the Quote: patients and the evaluators remained blinded to group assignment throughout the study.
Quote: "S-SDQ measures, pain intensity and in the range of movements were performed at 15 and 30 days after the injection of treatment and, afterwards, every month for 5 months more by one of the researchers (ABP), who was blinded to the treatment received."
Judgement Comment: Assessor blinded
Quote: "Patients were evaluated by the same clinician who evaluated the patient prior to the injection. Constant score and VAS score were evaluated and documented. The clinician was blinded of the clinico-radiological findings of the patient and the treatment group to which the patient belongs."
Quote: "All injections were administered by one of us (B. B.), who was independent of the examiner, in an opaque syringe with a 21-gauge needle. The"
Judgement Comment: The outcome assessors were blinded
Quote: "evaluations before and three and six weeks after treatment were made by a physiotherapist and an orthopedist who were unaware of the treat-"
Judgement Comment: The evaluations were made by a physiotherapist and an orthopedist who were unaware of the treatment.
Quote: "Patients and the outcome assessor were blinded to the allocation of treatment group; however,</b> the surgeon and sonographer performing"
Judgement Comment: Patients and the outcome assessor were blinded to the allocation of treatment group
Quote: "Outcomes were measured by self completed questionnaires at baseline and at one, six, and 12 weeks; a staff member other than the treating physiotherapist provided the questionnaires."
Judgement Comment: A staff member other than the treating physiotherapist provided the questionnaires Outcomes were self-reported outcomes, and patients were not blinded
Judgement Comment: Outcomes were self-reported and patient were blinded.
Judgement Comment: No information on blinding of outcome assessors. critical outcomes of interest (pain and function) were mostly self-reported and patients not blinded.
Quote: "The injection was prepared with sterile technique using opaque syringes so that participants, injection operators, and evaluators remained blinded to group assignment."
Judgement Comment: 'triple-blind'
Judgement Comment: All of the evaluations were performed by a blinded assessor who was a well-experienced physical therapist. The outcome assessor was blinded to the treatment assignment.
Quote: "Each patient was reviewed 6 weeks postinjection by the same rheuma- tologist who performed the initial clinical evaluation (FC), blinded to the injection technique and the sonographic findings."
Judgement Comment: PROMs only. Unclear if patients were blinded to allocation group.
Quote: "All injections were administered by the same physician (LIFP). Both physician and patients were blinded to the contents of the syringe. In order to achieve an effective blinded injection a 19 gauge 1.5 inch needle and a 10 ml syringe were used to prevent the physician identifying the difference in viscosity of the administered solutions. The syringes were filled by an independent trial nurse and masked with black adhesive tape. The nurse was thus responsible for the blinding procedure. Inclusion, follow-up assessments and data analysis were blinded for allocated treatment [22]."
Judgement Comment: PROMs. Patients blinded
Judgement Comment: After the 4-week evaluation, the code was broken.
Judgement Comment: After the 4-week evaluation, the code was broken.
Judgement Comment: A single consultant rheumatologist blinded to the results of ultrasound and to the treatment received by the patient, performed the shoulder evaluations at baseline and at 6 and 12 weeks post-injection.
Judgement Comment: No information on blinding of outcome assessors
Judgement Comment: No information on blinding of outcome assessors, assume not blinded.
Judgement Comment: No information on blinding of outcome assessors.
Quote: "not participating in the assessments. Both the patient and the assessing doctor were unaware in which group the patient was entered. The following</b> investigations were performed: full blood"
Judgement Comment: outcome assessors were blinded.
Quote: "Follow-up evaluation was performed by a rheumatol- ogist who was blinded to the results of the initial US and clinical assessments as well as the route of steroid administration."
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: All patients completed the 4-week study period
Judgement Comment: 1/15 was lost to follow-up in the blind injection group and 0/14 in the US-guided group.
Quote: "All the patients completed the study."
Judgement Comment: No dropouts
Quote: "All the patients completed the study."
Judgement Comment: No dropouts
Quote: "Of the 62 study patients, 4 patients formally withdrew, refusing further participation in the study (3 from the xylocaine group and 1 from the betamethasone group). Because the primary analysis was an intention-to-treat analysis, the scores at final follow-up before withdrawal have been carried forward for the duration of the study as a conservative estimation of outcome. The remaining 58 subjects (xylocaine = 28, betamethasone = 30) were fol- lowed as outlined in the study design."
Judgement Comment: Low number of dropouts. Intention to treat analysis
Judgement Comment: No description of the dropout rates for out timeframe of interest (1 month). No reasons for dropout stated.
Judgement Comment: No dropouts reported.
Judgement Comment: No information on attrition rate. No information of any Intention to Treat analysis.
Judgement Comment: No information on dropuot rates. No intention to treat analysis.
Quote: "All patients who received injections returned for follow- up at 6 weeks."
Judgement Comment: No dropouts
Judgement Comment: Patients’ data were analysed according to the randomised group irrespective of deviations from the protocol. Low and equal number of dropouts. 1/115 did not recieve injection in the Injection + exercise group and 2/115 did not recieve exercise in this group.1/117 in the exercise group did not recieve exercise.
Quote: "In group 1, 15 (65%) patients were injected in the subacromial space. Of the remaining eight patients, six were injected in the deltoid and two were injected in the rotator cuff. In group 2, 16 (70%) patients were injected in the subacromial space, 3 patients were injected in the deltoid, and 4 patients were injected in the rotator cuff."
Judgement Comment: 4 dropouts accounted for. Group allocation ns. Analysis ns 4 dropouts accounted for. Group allocation ns. Analysis ns All randomized patients recieved the intervention. No information of dropouts.
Judgement Comment: 8 patients excluded for named reasons prior to randomisation.No dropouts reported after randomisation.
Judgement Comment: Dropouts 3/5/3. Equally distributed. Reasons provided. Low number of dropouts for equal reasons.
Judgement Comment: 2 subjects in each group withdrew during the follow-up period due to reasons unrelated to the study. Low number of dropouts for equal reasons.
Judgement Comment: No information on attrition.
Judgement Comment: All dropouts accounted for. Equally distributed in groups. Low number of dropouts and intention to treat analysis
Judgement Comment: No dropouts accounted for after randomisation
Judgement Comment: No dropouts accounted for after randomisation
Judgement Comment: aproximately 20% in each group were excluded after randomization as they required repeat injection or surgical refferal. Dropouts accounted for. Balanced between groups
Judgement Comment: No reporting on attrition
Judgement Comment: No information on attrition.
Judgement Comment: 2 dropouts prior to randomisation accounted for. 1 in each group.
Judgement Comment: No information on attrition.
Judgement Comment: Dropouts accounted for. 1 and 2 in each group. Low and equal number of dropouts.
Reporting bias due to selective outcome reporting
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement comment: No protocol availabe, the study reports on all the outcomes stated in the methods section.
Judgement comment: No protocol availabe, the study reports on all the outcomes stated in the methods section.
Judgement comment: No protocol available. Outcome data were reported for all outcomes stated in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: Australian New Zealand Clinical Trials Registry (registration no. ACTRN12 615000562572).
Quote: "Trial registration ISRCT 25817033; EudraCT No 2005- 003628-20."
Judgement Comment: Trial registration ISRCT 25817033; EudraCT No 2005-003628-20. Reference to a protocol. Primary and secondary outcoems reported as stated in the protocol.
Judgement Comment: No protocol available. the study reports on all the putcome stated in the methods section.Total Constant score not reported (power measurement missing).
Judgement Comment: No protocol available, the study reports on all the outcomes stated in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section. Protocol registration not reportedUnexpected outcome: "Number of patients with 50% decrease in VAS for pain (VAS 50) and SFA score (SFA 50)."
Quote: "Trial registration: ISRCTN51511455."
Judgement Comment: All outcomes were reported according to the protocol
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section. One of our critical outcomes of interest (function) was not reported in the study. No protocol available. Outcome data were reported for all outcomes specified in the methods section. Oneof our critical outcomes of interest (function) was not reported in the study.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section. None of our outcomes of interest were reported in the study
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section.
Judgement Comment: No protocol available. Outcome data were reported for all outcomes specified in the methods section. One of our outcome of interest was not reported in the study (function) Outdated outcomes.
Judgement Comment: No protocol available. No methods section. None of our outcoems of interests were reported
Judgement Comment: Protocol registration not reported.Atypical outcome measures.
Bias due to problems not covered elsewhere in the table
Judgement Comment: No information of funding and conflicts of interests. The study appears to be free of other sources of bias.
Quote: "Declaration of conflicting interests The authors declared no conflicts of interest with respect to the authorship and/or publication of this article. Funding This study was supported by the Baskent University Research Fund."
Judgement Comment: Poor reporting of variance. Very low sample size.
Judgement Comment: No reporting of conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: No reporting of conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: No reporting of conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: Imbalance in duration of symptoms at baseline
Quote: "Conflict of interest The authors have none to declare. Funding No funding received."
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: Not clear if outcoems were measured at the same timepoints in the groups. No information of funding and conflicts of interest.
Judgement Comment: No information on funding and conflicts of interests. The study appears to be free of other sources of bias.
Judgement Comment: No information on conflicts of interests and funding. Seeems that results are gives per shoulder and not per person. Uklart hvornĺr hhv. antal patienter og antal skuldre indgĺr i beregningerne. Problematisk at inkludere to skuldre pĺ samme patient (ikke uafhćngige).
Quote: "Funding: The study was funded by a project grant 17236 from Arthritis Research UK. Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that (1) DPC and PGC have support from Arthritis Research UK for the submitted work. All authors declare no interests under (2), (3), and (4)."
Judgement Comment: The study appears to be free of other sources of bias.
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Quote: "Conflict of Interest: The authors declare that there is no conflict of interests regarding the publication of this paper."
Judgement Comment: No information on funding.The study appears to be free of other sources of bias
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Quote: "Competing interests: The authors declare that they have no competing interests". No information on funding
Judgement Comment: 100 patients included. Population with known high rate of substance abuse, no dropouts seems unlikely. No information on conflicts of interests and funding.
Judgement Comment: 100 patients included. Population with known high rate of substance abuse, no dropouts seems unlikely. No information on conflicts of interests and funding.
Judgement Comment: Uklart hvornĺr hhv. antal patienter og antal skuldre indgĺr i beregningerne. Problematisk at inkludere to skuldre pĺ samme patient (ikke uafhćngige). No information on conflicts of interests and funding. The study appears to be free of other sources of bias No information on conflicts of interests and funding. The study appears to be free of other sources of bias
Judgement Comment: Poor reporting. No information on conflicts of interests and funding
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: No information on conflicts of interests and funding. The study appears to be free of other sources of bias.
Judgement Comment: "New infiltrations after two weeks were tolerated but considered as poor results."Unclear how many repeated injections were given and how "poor results" were reported.