Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: customized insoles; Other: ready made insoles

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: customized insoles; 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; 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; Other Names: customized full-length lateral wedged insoles: ICB
Placebo Comparator: ready made insoles; 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; 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; Other Names: ready made full-length lateral wedged insoles: La New

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 11, 2013
• Last Update Submitted That Met QC Criteria: January 9, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: knee osteoarthritis; therapeutic effect; insole
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SKH-8302-102-DR-32