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

Effect of Unloader Knee Brace and Biomechanical Footwear Device on Symptoms and Physical Function in Knee Osteoarthritis Patients - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis,Knee
• Intervention / Treatment: Other: Home-based exercise; Device: Knee brace; Device: Biomechanical footwear device

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Jyväskylä, Finland, 40700
    • Central Finland Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Exercise therapy group; (n = 40)	Other: Home-based exercise; Home-based exercises three times per week.
EXPERIMENTAL: Knee brace and exercise group; (n = 40)	Other: Home-based exercise; Home-based exercises three times per week.; Device: Knee brace; Progressive use of knee brace each day during activities of daily living.
EXPERIMENTAL: Footwear device group; (n = 40)	Device: Biomechanical footwear device; Progressive use of footwear each day during activities of daily living.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Pain intensity at 4 months: VAS	Visual Analog Scale for Pain (score of 100 mm). No pain (score of 0), worst imaginable pain (score of 100).	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline clinical symptoms at 4 months.	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-questionnaire evaluates the condition of patients with knee osteoarthritis including pain, stiffness and physical function. In the subscale of pain (score range 0 - 500), stiffness (score range 0 - 200), and functional limitation (score range 0 - 1700) lower values represent a better outcome. In order to normalize each score on 0 - 100 scales, the following correction factors are used: pain 0.20, stiffness 0.50, functional limitation 0.059.	4 months
Change from baseline Health-Related Quality of Life at 4 months: SF-36	The SF-36-Item Health Survey measures Health-Related Quality of Life. The SF-36 is a multi-item scale assessing eight health concepts: 1) limitations in physical activities, 2) limitations in social activities, 3) limitations in usual role activities, 4) bodily pain, 5) general mental health, 6) limitations in usual role activities, 7) vitality, and 8) general health perceptions, with scores for each dimensions ranging from 0 (poor health) to 100 (good health).	4 months
Change from baseline isometric knee extension and flexion forces at 4 months.	Will be measured with dynamometer	4 months
Change from baseline walking speed gait parameter at 4 months.	Walking speed (cm/sec) will be measured by the instrumented walkway system (GAITRite mat).	4 months
Change from baseline cadence gait parameter at 4 months.	Cadence (steps per minute) will be measured by the instrumented walkway system (GAITRite mat).	4 months
Change from baseline stride length gait parameter at 4 months.	Stride length, i.e., the distance between 2 successive placement of the same foot (cm) will be measured by the instrumented walkway system (GAITRite mat).	4 months
Change from baseline step length gait parameter at 4 months.	Step length, i.e., the distance measured from the heel point of one foot to the heel point of the other foot (cm) will be measured by the instrumented walkway system (GAITRite mat).	4 months
Change from baseline stance time and % stance gait parameter at 4 months.	Stance time (sec) and % stance will be measured by the instrumented walkway system (GAITRite mat).	4 months
Change from baseline swing time and % swing gait parameter at 4 months.	Swing time (sec) and % swing will be measured by the instrumented walkway system (GAITRite mat).	4 months
Change from baseline 40 m Fast-paced Walk Test at 4 months.	A fast-paced walking test that is timed over 4 x 10m for a total 40 m	4 months
Change from baseline Stair Ascend/Descend Test at 4 months.	The time (sec) it takes to ascend and descend a flight of stairs. The total time to ascend and descend steps (negative number indicates better performance) will be recorded and reported	4 months
Change from baseline 30s Timed Chair Stand Test at 4 months.	The maximum number of chair stand repetitions possible in a 30 second period. The total number of chair stands (up and down equals one stand) completed in 30 seconds will be reported.	4 months
Change from baseline knee range of movement at 4 months.	Will be measured with goniometer	4 months
Change from baseline physical activity at 4 months.	The short form of International Physical Activity (IPAQ-SF) questionnaire measures data on Health-Related Physical Activity. The IPAQ-SF Records the activity of four intensity levels (vigorous-intensity, moderate-intensity, walking, sitting) for the last 7 days. Results are reported as a continuous variable (MET minutes a week). To calculate MET minutes a week the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) is multiplied by the minutes the activity was carried out and again by the number of days that the activity was undertaken. To get total MET minutes of physical activity a week, the MET minutes achieved in each category are added together. Higher MET-values represent better outcome.	4 months
Change from baseline cost-utility at 4 months.	Will be measured with the items of the SF-6D questionnaire, which in turn can be converted from the items of the SF-36 questionnaire. The SF-6D score varies from 0 to 1, 0 representing worst health cost-utility and 1 best health utility.	4 months

Collaborators and Investigators

• Sponsor: Central Finland Hospital District
• Investigators: Principal Investigator: Jari Ylinen, Ph.D., M.D., Central Finland Hospital District; Study Chair: Arja Häkkinen, Ph.D., Central Finland Hospital District; Study Chair: Konsta Pamilo, M.D., Central Finland Hospital District; Study Chair: Ari Heinonen, Ph.D., University of Jyväskylä, Finland; Study Chair: Joost Dekker, Ph.D., VU University Medical Center, Amsterdam, Netherlands; Study Chair: Jari Arokoski, Ph.D, M.D., University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (ACTUAL): September 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: exercise; RCT; Knee brace; biomechanical footwear
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Dnro 11U/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO