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OpenTrials
Completed

NCT Number: NCT02388646

Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoIndy

Greenwood, Indiana, 46143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Assessment of Pain Using the Visual Analog Scale

    Time frame: Baseline and 3-month Visit

    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.

Secondary outcomes

  1. Change in Quadriceps Force

    Time frame: Baseline and 3-month Visit

    Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month.

Sponsors and collaborators

Lead sponsor

Orthopaedic Research Foundation

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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