N/A
N=60
Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
Knee Osteoarthritis · Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02388646 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Assessment of Pain Using the Visual Analog Scale — 48.7; 62.6; 50.8; 27.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Only (Other); Brace Only (Device); Bracing + Exercises (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Orthopaedic Research Foundation
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Pain Using the Visual Analog Scale |
48.7; 62.6; 50.8; 27.1; 20.7; 13.2 | — |
| SECONDARY Change in Quadriceps Force |
.25; .15; .31 | — |
Summary
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
Eligibility Criteria
Inclusion Criteria
- Subject is being treated for knee joint pain
- Subject is willing and able to comply with the evaluation schedule
Exclusion Criteria
- Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
- Subject has current alcohol, opioid, or other drug dependence
- Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
Data sourced from ClinicalTrials.gov (NCT02388646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.