Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.

Detailed Description
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A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.

Official Title
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Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: customized insoles
* Other: ready made insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment Exclusion Criteria: with a history of previous knee surgery with an implant reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded pregnant or planning to become pregnant self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: customized insoles<br>customized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects | Other: customized insoles<br>* To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance<br>* Other names: customized full-length lateral wedged insoles: ICB;|
| Placebo Comparator: ready made insoles<br>ready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects | Other: ready made insoles<br>* To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance<br>* Other names: ready made full-length lateral wedged insoles: La New;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Visual analog scale, pain pressure threshold | change from baseline at one month and three months after modified shoe insoles wearing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functional ability | 10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time | change from baseline at one month and three months after modified shoe insoles wearing | 
| psychological function | Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire | change from baseline at one month and three months after modified shoe insoles wearing | 
| functional performance | Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score | change from baseline at one month and three months after modified shoe insoles wearing | 
| quality of life | World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life | change from baseline at one month and three months after modified shoe insoles wearing | 
| balance performance | static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk | change from baseline at one month and three months after modified shoe insoles wearing | 
| physical activity | CHAMPS physical activity questionnaire | change from baseline at one month and three months after modified shoe insoles wearing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, therapeutic effect, insole