Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
customized insoles
ready made insoles
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, therapeutic effect, insole
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
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
customized insoles
ready made insoles
Arm Description
customized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects
ready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects
Outcomes
Primary Outcome Measures
pain
Visual analog scale, pain pressure threshold
Secondary Outcome Measures
Physical functional ability
10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time
psychological function
Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire
functional performance
Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score
quality of life
World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life
balance performance
static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk
physical activity
CHAMPS physical activity questionnaire
Full Information
NCT ID
NCT01765101
First Posted
January 4, 2013
Last Updated
January 9, 2013
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01765101
Brief Title
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
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, therapeutic effect, insole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
customized insoles
Arm Type
Experimental
Arm Description
customized full-length lateral wedged shoe insoles
1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects
Arm Title
ready made insoles
Arm Type
Placebo Comparator
Arm Description
ready-made full-length lateral wedged shoe insoles at 1 and 3 months
study the immediate, short-term and intermediate-term therapeutic effects
Intervention Type
Other
Intervention Name(s)
customized insoles
Other Intervention Name(s)
customized full-length lateral wedged insoles: ICB
Intervention Description
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
Intervention Name(s)
ready made insoles
Other Intervention Name(s)
ready made full-length lateral wedged insoles: La New
Intervention Description
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
Primary Outcome Measure Information:
Title
pain
Description
Visual analog scale, pain pressure threshold
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
Secondary Outcome Measure Information:
Title
Physical functional ability
Description
10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
Title
psychological function
Description
Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
Title
functional performance
Description
Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
Title
quality of life
Description
World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
Title
balance performance
Description
static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
Title
physical activity
Description
CHAMPS physical activity questionnaire
Time Frame
change from baseline at one month and three months after modified shoe insoles wearing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2531
Email
M001052@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2531
Email
M001052@ms.skh.org.tw
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
12. IPD Sharing Statement
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Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis
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