Stick Versus Quadricep Exercise for Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Boonme stick exercise
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, exercise
Eligibility Criteria
Inclusion Criteria:
- knee osteoarthritis using Altman criteria
Exclusion Criteria:
- problem of communication ability
Sites / Locations
- Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quadricep strengthening exercise
Arm Description
Quadricep strengthening exercise
Outcomes
Primary Outcome Measures
vas score
Secondary Outcome Measures
WOMAC
number of analgesic used
Full Information
NCT ID
NCT01017445
First Posted
November 17, 2009
Last Updated
May 12, 2012
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01017445
Brief Title
Stick Versus Quadricep Exercise for Knee Osteoarthritis
Official Title
Boonme Stick Exercise vs. Quadriceps Strengthening Exercise in Knee Osteoarthritis : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the efficacy between Boonme stick exercise and quadriceps strengthening exercise in knee osteoarthritis.Patients diagnosed as knee osteoarthritis using Altman criteria will be randomized into 2 groups using simple random technique. Patients will be instructed and trained for both quadriceps or Boonme stick exercise by one-trained physical therapist. All patients will be treated with behavioral modification, NSAIDs and analgesic drugs and regularly follow-up . Assessment included visual analogue scale, exercise compliance, WOMAC and patient satisfaction were done by an assessor in a blinded fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quadricep strengthening exercise
Arm Type
Experimental
Arm Description
Quadricep strengthening exercise
Intervention Type
Other
Intervention Name(s)
Boonme stick exercise
Intervention Description
individual exercise daily
Primary Outcome Measure Information:
Title
vas score
Time Frame
1,2 years
Secondary Outcome Measure Information:
Title
WOMAC
Time Frame
1,2 yrs
Title
number of analgesic used
Time Frame
1,2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
knee osteoarthritis using Altman criteria
Exclusion Criteria:
problem of communication ability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonsin Tangtrakulwanich, MD.,Ph.D
Organizational Affiliation
Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
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Stick Versus Quadricep Exercise for Knee Osteoarthritis
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