Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

Orthopaedic Research Foundation

Status: Completed

Conditions: Arthritis; Knee Osteoarthritis

Treatments: Other: Bracing + Exercises; Device: Brace Only; Other: Exercise Only

Study type: Interventional

Funder types: Other

Identifiers

NCT02388646

FRKDJO-RWB-15

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Exercise Only

Active Comparator group

Description:

Home exercise program.

Treatment:

Other: Exercise Only

Brace Only

Active Comparator group

Description:

Reaction Web brace.

Treatment:

Device: Brace Only

Bracing + Exercises

Active Comparator group

Description:

Reaction Web brace and home exercises.

Treatment:

Other: Bracing + Exercises