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Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee, Menopause

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Shortwave diathermy
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Diathermy, Short-wave therapy, Osteoarthritis, Knee

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: peri- or postmenopausal women aged >50 years primary knee osteoarthritis Exclusion Criteria: inability to walk severe joint instability history of previous shortwave diathermy intra-articular injection within 3 months metallic implant around knee joint suspicious of malignancy around knee joint significant cardiovascular disease inability to understand how to score the symptoms

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Shortwave diathermy

control

Arm Description

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Outcomes

Primary Outcome Measures

The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The total score ranges from 0 (best outcome possible) to 10 (worst outcome possible).

Secondary Outcome Measures

Gait Speed (Calculated From the Time Spending for 100-meter Walk)
Global Improvement
Patient's Satisfaction to the Treatment
Adverse Events

Full Information

First Posted
September 12, 2005
Last Updated
September 17, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00199914
Brief Title
Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis
Official Title
The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether shortwave diathermy is effective in reducing knee pain and increasing function of the patients with knee osteoarthritis.
Detailed Description
Osteoarthritis (OA) is the most common degenerative joint disease, resulting in significant morbidity and health care expense. It affects more than 60% of Western World adults over the age of 65 years. It causes pain and dysfunction in 20% of elderly persons. It can affect any joint containing hyaline cartilage; knee is the most commonly affected joint. There are many strategies for the treatment of knee OA but a curative method has not been found. Treatment is therefore aimed to relief symptoms and to prevent further functional deterioration. It is unclear whether any of the treatment modalities is efficacious. Shortwave diathermy (SWD) is one of deep heat widely applied to alleviate the symptoms associated with OA. The efficacy of SWD for the treatment of OA knee is still inconclusive. The outcome of treatment in previous reports varies from null to positive effect. This discrepancy is largely due to the different research methodology, the inadequate sample size, the methods used in outcome assessment, and the treatment protocols. Comparison(s): Peri- or postmenopausal women with OA knee are randomized into two groups, receiving a course of either therapeutic SWD or sham SWD. The main outcome measured is the change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Menopause
Keywords
Diathermy, Short-wave therapy, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shortwave diathermy
Arm Type
Experimental
Arm Description
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Arm Title
control
Arm Type
Sham Comparator
Arm Description
continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Intervention Type
Device
Intervention Name(s)
Shortwave diathermy
Intervention Description
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Primary Outcome Measure Information:
Title
The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Description
The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The total score ranges from 0 (best outcome possible) to 10 (worst outcome possible).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Gait Speed (Calculated From the Time Spending for 100-meter Walk)
Time Frame
3 weeks
Title
Global Improvement
Time Frame
3 weeks
Title
Patient's Satisfaction to the Treatment
Time Frame
3 weeks
Title
Adverse Events
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: peri- or postmenopausal women aged >50 years primary knee osteoarthritis Exclusion Criteria: inability to walk severe joint instability history of previous shortwave diathermy intra-articular injection within 3 months metallic implant around knee joint suspicious of malignancy around knee joint significant cardiovascular disease inability to understand how to score the symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Rattanachaiyanont, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The present study start date was before January 18, 2017; therefore we did not plan to share IPD. However, the IPD is available upon request to the correspondent.
Citations:
PubMed Identifier
18178111
Citation
Rattanachaiyanont M, Kuptniratsaikul V. No additional benefit of shortwave diathermy over exercise program for knee osteoarthritis in peri-/post-menopausal women: an equivalence trial. Osteoarthritis Cartilage. 2008 Jul;16(7):823-8. doi: 10.1016/j.joca.2007.10.013. Epub 2008 Feb 21.
Results Reference
result

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Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis

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