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Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124462
First Posted: July 28, 2005
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston University
  Purpose

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.

Condition Intervention
Knee Osteoarthritis Device: Realigning knee brace and custom orthodic Device: Non realigning knee brace and flat orthodic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee) [ Time Frame: Baseline and 12 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.

  • Change in WOMAC Function Scale (Most Symptomatic Treated Knee) [ Time Frame: Baseline and 12 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.


Enrollment: 80
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Realignment to Placebo
Realigning knee brace and custom orthodic- A valgus brace, customized functional orthotic for neutral foot position and motion control footwear.
Device: Realigning knee brace and custom orthodic
A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
Device: Non realigning knee brace and flat orthodic
A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
Placebo to Realignment
Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
Device: Realigning knee brace and custom orthodic
A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
Device: Non realigning knee brace and flat orthodic
A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124462


Locations
United States, Massachusetts
Boston University, School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: David J Hunter Boston University
  More Information

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00124462     History of Changes
Other Study ID Numbers: H-24147
H133G040201 ( Other Grant/Funding Number: NIDRR )
First Submitted: July 26, 2005
First Posted: July 28, 2005
Results First Submitted: April 18, 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases