Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

NCT ID: NCT01765101

Last Updated: 2013-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

Brief 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.

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

customized insoles

customized full-length lateral wedged shoe insoles

1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects

Group Type: EXPERIMENTAL

customized insoles

Intervention Type: OTHER

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

ready-made full-length lateral wedged shoe insoles at 1 and 3 months

study the immediate, short-term and intermediate-term therapeutic effects

Group Type: PLACEBO_COMPARATOR

ready made insoles

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

customized full-length lateral wedged insoles: ICB; ready made full-length lateral wedged insoles: La New

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ru-Lan Hsieh

MD, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Ru-Lan Hsieh, MD

Role: CONTACT

M001052@ms.skh.org.tw

886-2-28332211 ext. 2531

Facility Contacts

Ru-Lan Hsieh, MD

Role: primary

M001052@ms.skh.org.tw

886-2-28332211 ext. 2531

Other Identifiers

SKH-8302-102-DR-32

Identifier Type: -

Identifier Source: org_study_id