Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis

NCT01866176

Knee Osteoarthritis

COMPLETED NA

Muscle Strengthening Device for Knee Osteoarthritis

NCT00007241

Osteoarthritis

COMPLETED PHASE2

Determining the Effectiveness of a New Phototherapy Treatment for the Knee Osteoarthritis

NCT04234685

Osteoarthritis, Knee

COMPLETED NA

Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis

NCT00375544

Osteoarthritis, Knee

COMPLETED PHASE1

Wearable Sensors in Knee OA

NCT04243096

Knee Osteoarthritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise Only

Home exercise program.

Group Type ACTIVE_COMPARATOR

Exercise Only

Intervention Type OTHER

This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.

Brace Only

Reaction Web brace.

Group Type ACTIVE_COMPARATOR

Brace Only

Intervention Type DEVICE

This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.

Bracing + Exercises

Reaction Web brace and home exercises.

Group Type ACTIVE_COMPARATOR

Bracing + Exercises

Intervention Type OTHER

This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise Only

This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.

Intervention Type OTHER

Brace Only

This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.

Intervention Type DEVICE

Bracing + Exercises

This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No