[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Clinical criteria for diagnosis of OA of the hip or knee established by the American College of Rheumatology
Excluded criteria: Rheumatoid arthritis; previous knee or hip joint replacement surgery of the affected joint; any other surgical procedure on the lower limbs in the previous 6 months; surgical procedure on the lower limbs planned in the next 6 months; initiation of opioid analgesia or corticosteroid or analgesic injection intervention for hip or knee pain within the previous 30 days; physical impairments unrelated to the hip or knee which would prevent safe participation in exercise, manual therapy, walking or stationary cycling; inability to comprehend and complete study assessments or comply with study instructions; or stated inability to attend or complete the proposed course of intervention and follow-up Schedule.
Pretreatment: Table 1WOMAC higher in Intervention Group (114.8 vs. 93.8) out of 240 but knee and hip OA Groups are combinedPain intensity score higher in intervention Group (4.2 vs. 3.1) out of 10 but knee and hip OA Groups are combined
Intervention Characteristics
Intervention
Control
Smerte
Patientrapporteret funktionsevne
Helbredsrelateret livskvalitet
Forværring hoftemserte >24 t efter MT
Præstationsbaseret funktionsevne
Smerte (ikke hofterelateret)
Sponsorship source: Role of the funding source: The MOA Trial was funded by research contracts from the Health Research Council of New Zealand (HRC 07/199 and 07/200) and the New Zealand Lottery Grants Board (MR212664). JHA, MCR, GDB, JCTand AJC were all supported, in part, by grants from the Health Research Council. CC, DP and AAW were supported, in part, by graduate student scholarship funding from the Health Research Council. JHA was also supported in part by a grant from the Lottery Grants Board and by the Centre for Physiotherapy Research. All co-authors were supported in part by the University of Otago. JHA is currently supported by the Health Research Council as a Sir Charles Hercus Health Research Fellow. The researchers were independent from the funders: neither the Health Research Council nor the Lottery Grants Board had any role in study design, data collection,analysis, interpretation or reporting, or the decision to write and submit the paper.
Country: New Zealand
Setting: Specific setting not listed. Patients referred from GPs with hip or knee OA and from GPs referred for consideration of THA or TKA
Comments:
Authors name: JH Abbott
Institution:
Email:
Address:
Nkr 41 Hofte on 27/02/2016 00:03
Outcomes
Results are pooled for hip and knee OA, except for WOMAC 1 year follw up Uncertainty concerning n for hip OA in the two groups, see Table I and III
Erik Poulsen on 27/02/2016 08:31
Outcomes
Studiet bruger en composit score (samlet WOMAC) som indeholder smerte, led stivhed og funktion.Alle andre outcomes rapporteret er ikke opdelt i hofte vs. knee OA
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: >3 months of groin or buttock activity related painRestricted hip movement>50 yearsmorning stiffness no more than ½ hrProficient English languageAble to attend 6 weekly treatment sessions
Excluded criteria: Previous hip fracture, dislocation or surgeryCongenital hip dysplasiaInflammatory arthritisosteoporosisHistory of malignancy around the hipSevere LBP or radiculopathy below the kneeComorbidity excluding participant from MT or ExeT (cardiovascular insult, pulmonary disease or obesity)MT or corticosteroid injection for the hip within the last 3 months
Pretreatment: Longer symptoms duration in intervention group compared to controlHigher baseline pain level in intervention group compared to control
Intervention Characteristics
Intervention
Control
Smerte
Patientrapporteret funktion
Helbredsrelateret livskvalitet
Forværring hoftemserte >24 t efter MT
Præstationsbaseret funktionsevne
Smerte (ikke hofterelateret)
Sponsorship source: Funding: none; COI: none
Country: UK
Setting: NHS community musculoskeletal service. Convinience sample referred from GPs
Comments:
Authors name: Fiona Blackman
Institution:
Email:
Address:
Nkr 41 Hofte on 25/02/2016 23:51
Study Design
Pilot study
Nkr 41 Hofte on 26/02/2016 01:08
Outcomes
Adverse events: There were no reported harms or unintended effects in either group
Erik Poulsen on 26/02/2016 08:56
Outcomes
No adverse events reported but no mentioning of how reporting was collected
Erik Poulsen on 26/02/2016 22:52
Population
Hej Lone,Forskellen i change score efter intervention er højst sandsynligt pga. den store baseline forskel i VAS.
Study design: Randomized controlled trial
Study grouping: Crossover
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: OA of the hip according to the American College of Rheumatology clinical and radiographiccriteria and were aged 40 to 80 years.
Excluded criteria: Exclusion criteria included previous hip arthroplasty, congenital or adolescent hip disease, clinical signs of lumbar spine disease, physiotherapy in the previous 6 months for hip symptoms, pregnancy, hip fracture, contraindications to ET,24 inflammatory arthritis, on the waitlist for hip joint replacement within the next 7 months, intra-articular hip corticosteroid injection in the previous 30 days, or insufficient understanding of the English language to complete questionnaires
Pretreatment: Both hips involved (ET group 17% and ET+MT Group 31%) Table 1
Intervention Characteristics
Intervention
Control
Smerte
Patientrapporteret funktionsevne
Helbredsrelateret livskvalitet
Forværring hoftemserte >24 t efter MT
Præstationsbaseret funktionsevne
Smerte (ikke hofterelateret)
Sponsorship source: Supported by a Fellowship for the Therapy Professions from the Health Research Board,Ireland (grant no. CTPF-06-12).No commercial party having a direct financial interest in the results of the research supportingthis article has or will confer a benefit on the authors or on any organization with which the authorsare associated
Country: Ireland
Setting: Four academic teahing hospitals with referrals from physio waiting lists, GPs, reumatologists, orthopedic surgeons, other hospital consultants
Comments:
Authors name: HP French
Institution:
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: -patients referred from general practitioner, chiropractor or orthopaedic surgeon-unilateral hip pain of minimum 3 months' duration-radiology criteria for hip OA: joint space width (JSW) < 2.0 mm or a side difference in JSW of > 10%-adequate mastering of the Danish language to complete instructions and questionnairesDuring thefirst 2 months of recruitment, three exclusion criteriawere added to the original criteria1: patients who had had MTwithin the previous twelve months2; patients who rated their painseverity as 1 or 2 on the primary outcome 11-box numericalrating scale (NRS), since improvement would not be measurable3;patients with polyarthritis, defined as having OA-like symptomsfrom more than three anatomic areas.
Excluded criteria: -inflammatory joint disease-previous hip or knee alloplastic-secondary arthritis due to hip fracture or infection-bilateral hip pain-hip dysplasia with a CE angle > 25 degrees and an AA angle > 10 degrees-low back pain which dominates over the hip pain-malignant disease-patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease-hip pain resulting from labral tear, bursitis and/or snapping hip syndrome-polyarthritis-received manual treatment for the hip within the last year
Pretreatment: Longer symptoms duration in the control group compared to intervention group
Intervention Characteristics
Intervention
Control
Smerte
Patientrapporteret funktionsevne
Helbredsrelateret livskvalitet
Forværring hoftemserte >24 t efter MT
Præstationsbaseret funktionsevne
Smerte (ikke hofterelateret)
Sponsorship source: All authors declare that they have no competing interests.
Country: Denmark
Setting:
Comments:
Authors name: Poulsen et al. 2013
Institution:
Email:
Address:
Nkr 41 Hofte on 25/02/2016 21:30
Interventions
It is a 3-arm RCT, we only extract data from 2 arms
Conference abstract
Included via systematic reviews
Conference abstract
Wrong study design
Wrong study design
Not english language
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
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
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Judgement Comment: Of the participants randomised to the three active interventiongroups, 88.3% attended of at least 80% of scheduled interventionvisits
Judgement Comment: Data collected for almost all participants
Judgement Comment: Attrition rate at the 18-week follow-up was higher than the a prioriestimated rate of 10%. An overall dropout rate of 14.5%
Judgement Comment: Retrieved from Wang, 2015
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: Assessors blind to group allocation performed assessments atbaseline, 9 weeks, 6 months and 1 year. But not all outcomes reported as mentioned in the Methods section: 9 weeks and 6 months.
Judgement Comment: All outcomes reported
Judgement Comment: All outcomes reported in Tables
Judgement Comment: Retrieved from Wang, 2015
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Blinding not possible for patients and therapists
Judgement Comment: Participants and therapists were not blinded to interventions
Judgement Comment: Participants and therapists could not be blinded
Judgement Comment: Retrieved from Wang, 2015
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: After baseline assessment, participants were randomised usingTENALEA, an online randomisation service15. Randomisation was stratified by condition (hip or knee). Within each stratum, participants were randomised to one of the four intervention groups using block allocation. The block sizewas subject to randomvariation
Judgement Comment: Two computer generated randomization lists were compiled by anindependent statistician.
Judgement Comment: Fra SR Wang et al. 2015 Fra SR Wang et al. 2015
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Judgement Comment: The TENALEA service generated and held the randomisationschedule, ensuring allocation concealment.
Judgement Comment: Not described how concealment was carried out.
Judgement Comment: Both lists were maintained by a member of the researchteam (T.C.), who was located offsite from the 4 trial centers andwas not involved in participant assessment or treatment. Group allocation was communicated via email by the independent randomizer to the treating therapists in each treatment site.
Judgement Comment: Retrieved from Wang, 2015
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Outcome assessors were blind to group allocation, and were notinvolved in providing the interventions. The statisticians conducting the statistical analyses were blind to group allocation until after the analyses were completed.
Judgement Comment: Blinding only performed for ½ of PROM of hip
Judgement Comment: A single assessor (H.P.F.), blinded to group allocation andmeasurement data from previous assessment points, carried out all outcome assessments. Patients were requested not to divulgeinformation regarding allocated treatment. Disclosure of groupallocation was recorded prospectively by the blinded assessor. Group assignment was disclosed to the outcome assessor by 5participants, who were all in the control group. No treatmentdisclosure occurred in the 2 intervention groups.
Judgement Comment: Retrieved from Wang, 2015
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: Co-intervention not mentioned. Compliance acceptable. Similar outcome assessment time
Judgement Comment: No intention-to-treat analysisSome baseline dissimilarity concerning pain severity and duration of symptoms
Judgement Comment: Intention to treat analysis mentioned. Co-intervention not mentioned. Compliance considered acceptable. Outcome assessed at similar times