Knee Bracing for People With Patellofemoral Osteoarthritis

• ClinicalTrials.gov Identifier: NCT00381563
• Recruitment Status: Completed
• First Posted: September 28, 2006
• Results First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Sponsor: Boston University
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): Boston University

Study Description

Brief Summary:

Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include pain, tenderness, stiffness, and inflammation. Studies have suggested that symptoms of knee osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint between the kneecap, called the patella, and the thigh bone, called the femur. This study will determine whether wearing a knee brace that realigns the patella over the femur is effective in relieving pain and improving function in adults with knee osteoarthritis.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Device: Patellofemoral realigning knee brace; Device: Non-aligning knee brace	Not Applicable

Detailed Description:

Bending and straightening at the knee causes the patella to glide along a groove in the femur bone. However, biomechanical imbalances can cause the patella to jump off track, which can lead to pain. Interventions that alter the load distribution across the patellofemoral joint, such as patella taping, may be helpful in alleviating symptoms. Patellar taping has in fact been shown to be effective in the short-term for treating patellofemoral osteoarthritis. But it has not been widely adopted in the clinical setting because it is complicated to administer, difficult to educate the patient about ongoing application, and lacks evidence of long-term efficacy. Also, patients often experience skin irritation from the taping and discomfort when removing the taping. An alternative treatment option is the use of a knee brace that realigns the tracking of the patella. This study will determine whether wearing a patellofemoral realigning knee brace is effective in relieving pain and improving function in adults with knee osteoarthritis.

Participation in this study will last about 3 to 9 months. All eligible participants will wear the same knee brace for a 2-week run-in period during which they will record when they wear the brace and any pain medication used. Next, participants will be randomly assigned to wear one of two knee braces for 6 weeks and a minimum of 4 hours each day. This will be followed by 6 weeks of wearing no knee brace, and then by 6 weeks of wearing whichever knee brace they did not wear during the first 6-week period. There will be a total of nine study visits. The first study visit will screen for eligible participants and will include an interview, knee evaluations, x-rays, and a urine pregnancy test. The second and sixth study visits will include knee evaluations, brace fittings, and instructions on how to correctly wear and adjust the brace. Most of the other study visits will consist primarily of interviews and functional tests. During the first and third 6-week periods, participants will maintain a log to record how long they wear their braces and any pain medication used. Participants will also wear an accelerometer, which will keep track of how many steps they take.

Participants will have the option of continuing in a 6-month follow-up period during which they can wear the brace of their choice. There will be three evaluations that will include questions on how participants are doing with their braces.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Bracing in Patellofemoral Osteoarthritis: A Clinical Trial
• Study Start Date: December 2006
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
Intervention to placebo; Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.	Device: Patellofemoral realigning knee brace; Knee brace that changes the tracking of the patella over the femur bone; Device: Non-aligning knee brace; Knee brace that does not change the tracking of the patella over the femur bone
Placebo to intervetion; Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.	Device: Patellofemoral realigning knee brace; Knee brace that changes the tracking of the patella over the femur bone; Device: Non-aligning knee brace; Knee brace that does not change the tracking of the patella over the femur bone

Outcome Measures

Primary Outcome Measures :

1. Change in Pain on the VIsual Analog Scale (VAS) [ Time Frame: 6 weeks ]
   The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100
2. Change in WOMAC Pain Scale [ Time Frame: 6 weeks ]
   The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.

Secondary Outcome Measures :

1. Change in WOMAC Function Scale [ Time Frame: 6 weeks ]
   The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Knee pain on most days
• Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray

Exclusion Criteria:

• Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or walker), or uses a wheelchair
• Pain emanating more from the back or hip than from the knee, as determined by screening questionnaire
• Low pain score on the visual analog scale (VAS) (less than 4 out of 10)
• Plans to move from the area within 10 months of study screening
• Symptomatic comorbid disease that limits activities more than knee pain does, as determined by screening questionnaire (e.g., congestive heart failure, chronic obstructive pulmonary disease)
• Receiving corticosteroid injections in the month before study entry, or receiving hyaluronan in the 6-month period before study entry. No other treatments will result in exclusion, although for patients taking glucosamine and/or chondroitin and/or a non-steroidal anti-inflammatory drug (NSAID), they must have taken these treatments for at least 2 months before study entry and must commit to not start a new treatment during the study.
• Bilateral total knee replacements or plans for a total knee replacement of the affected knee in the next 6 months
• Morbidly obese (body mass index greater than 35), as brace fitting and prevention of slippage of the brace will be difficult
• Known other causes of arthritis, including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, and pseudogout
• Skin breakdown at the site where the brace will be applied
• Failure to pass the run-in test, or the brace falls down the leg during the run-in

Contacts and Locations

Locations

United States, Massachusetts

Boston University, School of Medicine

Boston, Massachusetts, United States, 02118

New England Baptist Hospital

Boston, Massachusetts, United States, 02120

Sponsors and Collaborators

Boston University

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Principal Investigator: David Hunter, MD; Boston University

More Information

Publications of Results:

Hunter DJ, Harvey W, Gross KD, Felson D, McCree P, Li L, Hirko K, Zhang B, Bennell K. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis. Osteoarthritis Cartilage. 2011 Jul;19(7):792-800. doi: 10.1016/j.joca.2010.12.010. Epub 2011 Jan 11.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT00381563
• Other Study ID Numbers: H-25641; P60AR047785 ( U.S. NIH Grant/Contract ); 2P60AR047785-06 ( U.S. NIH Grant/Contract )
• First Posted: September 28, 2006
• Results First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Boston University:

Bracing; Patellofemoral; Osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases