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.
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.
Knee brace that changes the tracking of the patella over the femur bone
Knee brace that does not change the tracking of the patella over the femur bone
Boston University, School of Medicine
Boston, Massachusetts, United States
New England Baptist Hospital
Boston, Massachusetts, United States
Change in Pain on the VIsual Analog Scale (VAS)
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
Time frame: 6 weeks
Change in WOMAC Pain Scale
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.
Time frame: 6 weeks
Change in WOMAC Function Scale
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.
Time frame: 6 weeks
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80