Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, therapeutic effect, insole
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.
Interventions
OTHERcustomized 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
OTHERready 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
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain | change from baseline at one month and three months after modified shoe insoles wearing | Visual analog scale, pain pressure threshold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| psychological function | change from baseline at one month and three months after modified shoe insoles wearing | Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire |
| functional performance | change from baseline at one month and three months after modified shoe insoles wearing | Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score |
| Physical functional ability | change from baseline at one month and three months after modified shoe insoles wearing | 10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time |
| balance performance | change from baseline at one month and three months after modified shoe insoles wearing | static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk |
| physical activity | change from baseline at one month and three months after modified shoe insoles wearing | CHAMPS physical activity questionnaire |
| quality of life | change from baseline at one month and three months after modified shoe insoles wearing | World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life |
Countries
Taiwan
Contacts
Primary ContactRu-Lan Hsieh, MD
Outcome results
None listed