Research in Osteoarthritis in Manchester (ROAM) Brace | Not Recruiting
Research in Osteoarthritis in Manch... | Not Recruiting
Research in Osteoarthritis in Manchester (ROAM) Brace
ROAM Brace
Trial Source

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Medical Conditions
  • Topic: Musculoskeletal, Primary Care Research Network for England
  • Subtopic: Not Assigned, Musculoskeletal (all Subtopics)
  • Disease: Musculoskeletal, All Diseases
Primary Contact Details
Not Recruiting
Recruitment Status
50380458
Primary Trial ID Number

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Summary
Not provided at time of registration
Research Details
  • 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.
Phase
Phase IV
Study Design
Single centre randomised interventional treatment trial
Study Type
Interventional
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 Measures
    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
Publication(s)
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25596158
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M13 9PT
Trial Contact(s)
Primary Trial Contact
Mrs Fiona Stirling
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Patellofemoral brace treatment in patients with chronic painful patellofemoral osteoarthritis (PFOA): a single centre randomised interventional treatment trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Arthritis Research Campaign (ARC) (UK)
Other Study ID Numbers
7137
Sponsor(s)
University of Manchester (UK)
Key Dates

Recruitment Start Date

17 Aug 2009

Recruitment End Date

29 Mar 2013

Trial Start Date

17 Aug 2009

Trial End Date

29 Mar 2013

Date Assigned

21 May 2010

Last Updated

19 Jan 2015