Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

A Randomized Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124462
• Other study ID #: 84.133G-1
• Status: Completed
• Phase: N/A
• First received: July 26, 2005
• Last updated: January 28, 2009
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and improves function. The researchers will test the hypothesis that compared to control treatment, the use of realignment therapy (valgus knee brace + motion control shoes + orthosis) is effective in medial knee OA.

The specific aims are:

• To undertake a 30 week randomized crossover clinical trial in patients with medial knee osteoarthritis to determine whether provision of realignment therapy leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment;

• To perform an open label follow-up study to track use and effectiveness of treatment. This project will be co-funded by DonJoy Orthopedic, a knee bracing company.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Trial participants must meet American College of Rheumatology (ACR) criteria for osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of a definite osteophyte. In addition, because the researchers are interested in recruiting persons with medial knee osteoarthritis, participants will need to have evidence of disease in this compartment on their radiographs, and not have lateral compartment or patellofemoral compartment disease. Medial disease is based on definitions used in the researcher's previous publications as definite radiographic OA + at least grade 1 medial narrowing (0-3 scale) using an atlas from the Osteoarthritis Research Society International.

Exclusion Criteria:

• Individuals with clinical evidence of patellofemoral disease or knee pathology (other than medial compartment OA) likely to be causing their knee pain.

• Individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.

• Amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. Persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.

• Known neuropathy from diabetes or for other reasons.

• Past history of deep venous thrombosis.

• Pain emanating more from back or hip than from knee as determined by screening questionnaire

• Low pain score on WOMAC, a widely used and well validated questionnaire to assess knee symptoms. To evaluate response, the researchers will require that patients have a minimal score of at least 4 out of 10 on at least 2 of 5 questions, or a total of greater than 15 out of 50 for the WOMAC pain scale in the eligible knee at pre-randomization phone call and visit, and at randomization visit. This will allow us to detect response to treatment if response occurs.

• Planning to move from area within 9 months of study screening

• Symptomatic comorbid disease limits walking more than knee pain (per screening questionnaire)

• Receiving corticosteroid injections in the month prior to starting the trial. No other treatments will trigger exclusion, although for patients who have been on glucosamine +/or chondroitin +/or nonsteroidal anti-inflammatory drug (NSAID) the researchers will require that they must have taken these treatments for at least 2 months prior to onset of trial and to commit to not start a new treatment throughout the trial.

• Bilateral total knee replacements (TKR) or plan for TKR in next 6 months for affected knee.

• Known other causes of arthritis including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), gout, psoriatic arthritis, pseudogout.

• Failure to pass 4 week run-in test.

• Volunteers in a pre-contemplative state (persons who would not consider realignment therapy as a therapeutic option for their knee OA).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Brace and Shoe Insert
Realigning Knee brace and custom orthodic
• Knee brace and shoe insert
Non realigning knee brace and flat orthodic

Locations

Country	Name	City	State
United States	Boston University, School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain and Function Subscales (Most symptomatic treated knee)		12 weeks	No
Secondary	WOMAC Stiffness Subscale		12 weeks	No
Secondary	Knee Injury and Osteoarthritis Outcome Score		12 weeks	No
Secondary	Patient Global Assessment		12 weeks	No
Secondary	Overall Knee Pain Visual Analogue Scale (V.A.S.) (Knee specific)		12 weeks	No
Secondary	SF36		12 weeks	No
Secondary	Analgesic use (Medication log)		12 weeks	No
Secondary	Blinded knee exam by physician		12 weeks	No
Secondary	Physician Global Assessment		12 weeks	No
Secondary	Functional performance measures		12 weeks	No
Secondary	Proprioception		12 weeks	No