Research in Osteoarthritis in Manchester (ROAM) Brace
| ISRCTN | ISRCTN50380458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50380458 |
| Secondary identifying numbers | 7137 |
- Submission date
- 21/05/2010
- Registration date
- 21/05/2010
- Last edited
- 19/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mrs Fiona Stirling
Scientific
Scientific
University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
| fiona.stirling@manchester.ac.uk |
Study information
| Study design | Single centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.medicine.manchester.ac.uk/epidemiology/research/arc/clinicalepidemiology/roam |
| Scientific title | Patellofemoral brace treatment in patients with chronic painful patellofemoral osteoarthritis (PFOA): a single centre randomised interventional treatment trial |
| Study acronym | ROAM Brace |
| Study hypothesis | This study will form the first part of an Arthritis Research UK sponsored Osteoarthritis Programme grant to develop new treatment approaches for knee OA (Research in Osteoarthritis in Manchester - ROAM). There are three studies to be done in one group of PFOA patients. This will permit us to examine three related questions: Study 1: In a 6-week randomised trial compared to a no brace control, does the brace lead to diminution of synovitis and BMLs and reduction of pain and are these events related? Study 2: We will conduct a follow-up study for those in the trial. We will address whether in those who have noted a reduction in pain with the brace, does discontinuation of the brace lead to recurrence of pain and concomitant reappearance of magnetic resonance imaging (MRI) findings? Study 3: We will take measurements to test the third hypothesis that severity of knee pain is more strongly related to the degree of quadriceps muscle weakness, inhibition and pain and of hip abductor weakness than MRI findings in the knee including the size of the knee effusion (capsular distension) and the predominant compartment affected by PFOA. Pain diaries will be used to monitor pain medication usage during the trial. |
| Ethics approval(s) | Stockport REC approved on the 16th June 2009 (ref: 09/H1012/35) |
| Condition | Topic: Musculoskeletal, Primary Care Research Network for England; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases |
| Intervention | The Brace study is a cross over randomised controlled trial: Patient group 1: Receives a brace at the baseline visit for a period of twelve weeks, with checks at 6 and 12 weeks. Following this the patient is monitored for a period of 6 further weeks with no brace. Patient group 2: Receives no brace for the first at baseline, then is given a brace to wear at week 6 visit, for the subsequent 12 weeks (monitored at weeks 12 and 18). Both groups are therefore monitored for 18 weeks. Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure | VAS on nominated activity, measured at baseline, 6 weeks ,12 weeks and 18 weeks. |
| Secondary outcome measures | 1. Aggregated Locomotor Function, measured at baseline, 6 weeks, 12 weeks and 18 weeks 2. Hip Abduction Strength, measured at baseline, 6 weeks, 12 weeks and 18 weeks 3. Knee injury Osteoarthritis Outcome Score (KOOS), measured at baseline, 6 weeks, 12 weeks and 18 weeks 4. Quadriceps Inhibition, measured at baseline, 6 weeks, 12 weeks and 18 weeks 5. Quadriceps strength (secondary), measured at baseline, 6 weeks, 12 weeks and 18 weeks |
| Overall study start date | 17/08/2009 |
| Overall study end date | 29/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 144; UK sample size: 144 |
| Participant inclusion criteria | 1. Age 40 - 70 years, either sex 2. Radiographic evidence of Kellgren-Lawrence score 2 or 3 predominating in the PF joint 3. Evidence of a bone marrow lesion on a clinical MR scan, or documented evidence of at least grade 2 arthritis on arthroscopy 4. Patellofemoral pain reproduced with stair climbing, kneeling or squatting but not with standing or walking on level ground 5. A nominated activity that causes worst pain which must be at least moderate in severity (i.e. should be greater than or equal to 4 on a 0 - 10 visual analogue scale [VAS]) 6. Pain must have been present with this or other PF activities for the last 3 months 7. The patients will have lateral or medial patellar tenderness on palpation or a positive compression test 8. They should be on a stable medication regimen for 3 months (e.g. if the patients are using non-steroidal anti-inflammatory drugs [NSAIDs] there should be no change) 9. All participants must be willing to wear brace for 3 months daily 10. Potential subjects must have a treatable MRI feature also including either a bone marrow lesion in their PF joint (patella or opposing femoral trochlea) or synovitis on gadolinium scan |
| Participant exclusion criteria | 1. Previous patellar fracture or patellar realignment surgery 2. Predominant symptoms emanating from the tibiofemoral joint or from meniscal or ligament injury or if the patient has rheumatoid arthritis or other forms of inflammatory arthritis 3. If brace is not likely to work because the leg is too large 4. Intra-articular steroid injection into the painful knee in the last month or a viscosupplementation injection (such as Hyalgan, Durolane or Ostenil) with the last 3 months 5. If the patient is planning to move out of the area in next 3 months or will otherwise be unable to attend for follow up assessment 6. Those diagnosed with kidney disease or fatal disease 7. Usual exclusion criteria for the purposes of the MR scan |
| Recruitment start date | 17/08/2009 |
| Recruitment end date | 29/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Manchester
Manchester
M13 9PT
United Kingdom
M13 9PT
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Charity
Arthritis Research Campaign (ARC) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No |
