Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

NCT02388646 | Completed Results

• 1 other identifier: FRKDJO-RWB-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Arthritis

Outcome Measures

Primary Outcomes (1)

• Assessment of Pain Using the Visual Analog Scale

  The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.

  Baseline and 3-month Visit

Secondary Outcomes (1)

• Change in Quadriceps Force

  Baseline and 3-month Visit

Study Arms (3)

Exercise Only

ACTIVE COMPARATOR

Home exercise program.

Other: Exercise Only

Brace Only

ACTIVE COMPARATOR

Reaction Web brace.

Device: Brace Only

Bracing + Exercises

ACTIVE COMPARATOR

Reaction Web brace and home exercises.

Other: Bracing + Exercises

Interventions

Exercise Only 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.

Exercise Only

Brace Only DEVICE

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

Brace Only

Bracing + Exercises 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.

Bracing + Exercises

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is being treated for knee joint pain
• Subject is willing and able to comply with the evaluation schedule

You may not qualify if:

• 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)

Sponsors & Collaborators

• Orthopaedic Research Foundation: lead

Study Sites (1)

OrthoIndy

Greenwood, Indiana, 46143, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Interventions

Braces; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Frank Kolisek
• Organization: OrthoIndy

fkolisek@orthoindy.com

3178845160

Study Officials

• Frank R Kolisek, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 12, 2021
• Results First Posted: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)