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

Central Finland Hospital District

Status: Completed

Conditions: Osteoarthritis,Knee

Treatments: Device: Biomechanical footwear device; Device: Knee brace; Other: Home-based exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03684850

Dnro 11U/2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Exercise therapy group

Active Comparator group

Description:

(n = 40)

Treatment:

Other: Home-based exercise

Knee brace and exercise group

Experimental group

Description:

(n = 40)

Treatment:

Other: Home-based exercise

Device: Knee brace

Footwear device group

Experimental group

Description:

(n = 40)

Treatment:

Device: Biomechanical footwear device