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OpenTrials
Completed

NCT Number: NCT02443974

Bracing to Treat Knee Osteoarthritis in Elderly

Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Sao Paulo

São Paulo, 04023900, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pain in numerical pain scale between 3 and 7cm;
  • Knee ligamentous instability

Exclusion criteria

  • fibromyalgia and neurologic disease;
  • knee or hip replacement
  • surgery scheduled in the following 6 months
  • start physical activity or received joint injection in the past three months
  • need to use walking aids or brace in knee

Treatment and study plan

Brace (Fisiotensor®)

Device

Sleeve (Fisiotensor®)

Device

Primary outcomes

  1. Change in pain measured by a numeric pain scale

    Time frame: Baseline, after 45, 90 and 180 days

Secondary outcomes

  1. Change in function measured by Lequesne and WOMAC questionnaires

    Time frame: Baseline, after 45, 90 and 180 days

  2. Change in quality of life measured by SF-36 questionnaire

    Time frame: Baseline, after 45, 90 and 180 days

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 14, 2015
Registry last updated
Jul 1, 2016

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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