Clinical trial NCT01765101: Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
therapeutic effect
insole
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
Secondary outcomes:
measure: Physical functional ability
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
measure: psychological function
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
measure: functional performance
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
measure: quality of life
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
measure: balance performance
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
measure: physical activity
timeFrame: change from baseline at one month and three months after modified shoe insoles wearing
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: