Knee Bracing for People With Patellofemoral Osteoarthritis

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00381563
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 80
• Locations: 2
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 40
• Patients Per Site Per Month: 1.1

Study Details

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	N/A

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
• 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: Dec 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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) [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Boston University, School of Medicine	Boston	Massachusetts	United States	02118
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT00381563
• Other Study ID Numbers: H-25641; P60AR047785; 2P60AR047785-06
• First Posted: Sep 28, 2006
• Last Update Posted: Jun 29, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Recruitment Details	Subjects will be recruited through: public media including the Boston Metro, Community News, Baystate Banner and Tab, Craigslist; patients referred from BMC rheumatology, primary care, physical therapy, and orthopedics & from Baptist Hospital orthopedic clinics, and persons already recruited from studies whose consent forms allow contact

Arm/Group Title	Intervention to Placebo	Placebo to Intervention
Arm/Group Description	Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.	Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
Period Title: Overall Study
STARTED	41	39
COMPLETED	34	33
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	Intervention to Placebo	Placebo to Intervention	Total
Arm/Group Description	Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.	Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.	Total of all reporting groups
Overall Participants	41	39	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	27 65.9%	26 66.7%	53 66.3%
>=65 years	14 34.1%	13 33.3%	27 33.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (9.7)	61 (9.1)	60.6 (9.3)
Sex: Female, Male (Count of Participants)
Female	32 78%	31 79.5%	63 78.8%
Male	9 22%	8 20.5%	17 21.3%
Region of Enrollment (participants) [Number]
United States	41 100%	39 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pain on the VIsual Analog Scale (VAS)
Description	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

Outcome Measure Data

Analysis Population Description

In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the "intervention brace" group.

Arm/Group Title	Intervention Brace
Arm/Group Description	All participants who completed the trial (n=67) are re-grouped into the "intervention brace" group.
Measure Participants	67
Mean (95% Confidence Interval) [change in units on a scale from baseline]	-.068

2. Primary Outcome

Title	Change in WOMAC Pain Scale
Description	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

Outcome Measure Data

Analysis Population Description

In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the "intervention brace" group.

Arm/Group Title	Intervention Brace
Arm/Group Description	All participants who completed the trial (n=67) are re-grouped into the "intervention brace" group.
Measure Participants	67
Mean (95% Confidence Interval) [units on a scale change from baseline]	-0.11

3. Secondary Outcome

Title	Change in WOMAC Function Scale
Description	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

Outcome Measure Data

Analysis Population Description

In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the "intervention brace" group.

Arm/Group Title	Intervention Brace
Arm/Group Description	All participants who completed the trial (n=67) are re-grouped into the "intervention brace" group.
Measure Participants	67
Mean (95% Confidence Interval) [units on a scale change from baseline]	-0.02

Adverse Events

Arm/Group Title	Intervention to Placebo		Placebo to Intervention
Arm/Group Description	Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.		Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
All Cause Mortality
	Intervention to Placebo		Placebo to Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)
Serious Adverse Events
	Intervention to Placebo		Placebo to Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Intervention to Placebo		Placebo to Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)

Limitations/Caveats

There was no control group without a brace for comparison to the intervention because of concerns about unblinding.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.