Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01765101
• Other study ID #: SKH-8302-102-DR-32
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 4, 2013
• Last updated: January 9, 2013
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• 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

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Visual analog scale, pain pressure threshold	change from baseline at one month and three months after modified shoe insoles wearing	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	physical activity	CHAMPS physical activity questionnaire	change from baseline at one month and three months after modified shoe insoles wearing	No