Knee Brace and Biomechanical Footwear in the Treatment of Knee Osteoarthritis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-10-31

Brief Summary

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This study investigates the effects of unloader knee brace, biomechanical footwear device and exercise therapy on pain, physical function and quality of life in patients with knee osteoarthritis. The aim is to find more effective treatment strategies to delay or prevent heavy knee replacement surgeries.

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Detailed Description

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The aim of this study is to investigate the effects of exercising, and using a knee brace and exercising, and using of biomechanical footwear device on clinically important symptoms, physical function and quality of life in patients with osteoarthritis of the knee. The hypothesis is that the groups of using knee brace and biomechanical footwear can alleviate pain, improve physical function and quality of life more efficiently, than the group doing home exercises only.

The subjects (n = 120) will be randomized into three groups mentioned above, after which they will start to do exercises, or to use a knee brace and do exercises, or to use biomechanical footwear at home according to the instructions for 4 months. Physical function, symptoms and quality of life will be measured before and after 4-month intervention. In addition, at 12-month time point follow-up surveys will be addressed with regard to symptoms and quality of life, as well as to cost-effectiveness of the study.

Conditions

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Osteoarthritis,Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise therapy group

(n = 40)

Group Type ACTIVE_COMPARATOR

Home-based exercise

Intervention Type OTHER

Home-based exercises three times per week.

Knee brace and exercise group

(n = 40)

Group Type EXPERIMENTAL

Home-based exercise

Intervention Type OTHER

Home-based exercises three times per week.

Knee brace

Intervention Type DEVICE

Progressive use of knee brace each day during activities of daily living.

Footwear device group

(n = 40)

Group Type EXPERIMENTAL

Biomechanical footwear device

Intervention Type DEVICE

Progressive use of footwear each day during activities of daily living.

Interventions

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Home-based exercise

Home-based exercises three times per week.

Intervention Type OTHER

Knee brace

Progressive use of knee brace each day during activities of daily living.

Intervention Type DEVICE

Biomechanical footwear device

Progressive use of footwear each day during activities of daily living.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* moderate or severe knee pain (\>40mm on a VAS scale 0-100mm)
* radiographic knee osteoarthritis (Kellgren-Lawrence grades 1-3)
* age between 45 and 70 years

Exclusion Criteria

* inflammatory joint disease
* acute (\<6 months) knee trauma
* arthroscopic surgery in the past six months
* a planned knee replacement surgery or other planned surgical treatment of the knee
* knee injections in the past 3 months
* superficial wounds at the knee area
* arterial insufficiency
* severe varicosities
* impaired vision
* postural difficulties
* body-mass index (BMI) \>35kg/m2
* fibromyalgia
* rheumatoid arthritis or other active rheumatoid inflammatory disease.

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No