Clinical trial NCT03684850: Knee Brace and Biomechanical Footwear in the Treatment of Knee Osteoarthritis.
Official title: Effect of Unloader Knee Brace and Biomechanical Footwear Device on Symptoms and Physical Function in Knee Osteoarthritis Patients - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis,Knee
Keywords: Knee brace
biomechanical footwear
exercise
RCT
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Pain intensity at 4 months: VAS
timeFrame: 4 months
Secondary outcomes:
measure: Change from baseline clinical symptoms at 4 months.
timeFrame: 4 months
measure: Change from baseline Health-Related Quality of Life at 4 months: SF-36
timeFrame: 4 months
measure: Change from baseline isometric knee extension and flexion forces at 4 months.
timeFrame: 4 months
measure: Change from baseline walking speed gait parameter at 4 months.
timeFrame: 4 months
measure: Change from baseline cadence gait parameter at 4 months.
timeFrame: 4 months
measure: Change from baseline stride length gait parameter at 4 months.
timeFrame: 4 months
measure: Change from baseline step length gait parameter at 4 months.
timeFrame: 4 months
measure: Change from baseline stance time and % stance gait parameter at 4 months.
timeFrame: 4 months
measure: Change from baseline swing time and % swing gait parameter at 4 months.
timeFrame: 4 months
measure: Change from baseline 40 m Fast-paced Walk Test at 4 months.
timeFrame: 4 months
measure: Change from baseline Stair Ascend/Descend Test at 4 months.
timeFrame: 4 months
measure: Change from baseline 30s Timed Chair Stand Test at 4 months.
timeFrame: 4 months
measure: Change from baseline knee range of movement at 4 months.
timeFrame: 4 months
measure: Change from baseline physical activity at 4 months.
timeFrame: 4 months
measure: Change from baseline cost-utility at 4 months.
timeFrame: 4 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
Study officials:
affiliation: Central Finland Hospital District
name: Jari Ylinen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Hospital District
name: Arja Häkkinen, Ph.D.
role: STUDY_CHAIR
affiliation: Central Finland Hospital District
name: Konsta Pamilo, M.D.
role: STUDY_CHAIR
affiliation: University of Jyväskylä, Finland
name: Ari Heinonen, Ph.D.
role: STUDY_CHAIR
affiliation: VU University Medical Center, Amsterdam, Netherlands
name: Joost Dekker, Ph.D.
role: STUDY_CHAIR
affiliation: University of Eastern Finland
name: Jari Arokoski, Ph.D, M.D.
role: STUDY_CHAIR
References: