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 of protocol

Not provided at time of registration

Contact information

Mrs Fiona Stirling
Scientific

University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom

Email	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 objectives	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)
Health condition(s) or problem(s) studied	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
Completion 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
Key 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
Key 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
Date of first enrolment	17/08/2009
Date of final enrolment	29/03/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M13 9PT
United Kingdom

Sponsor information

University of Manchester (UK)
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