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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manee Rattanachaiyanont, Mahidol University
ClinicalTrials.gov Identifier:
NCT00199914
First received: September 12, 2005
Last updated: September 6, 2013
Last verified: September 2013

September 12, 2005
September 6, 2013
January 2004
May 2004   (final data collection date for primary outcome measure)
The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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 higher score reflects worse pain and stiffness and poorer physical function.
The change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Complete list of historical versions of study NCT00199914 on ClinicalTrials.gov Archive Site
  • Gait Speed (Calculated From the Time Spending for 100-meter Walk) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Global Improvement [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Patient's Satisfaction to the Treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • The changes in the following parameters:
  • - gait speed (calculated from the time spending for 100-meter walk)
  • - global improvement
  • - patient’s satisfaction to the treatment
Not Provided
Not Provided
 
Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis
The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Menopause
Device: Shortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
  • Experimental: Shortwave diathermy
    continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
    Intervention: Device: Shortwave diathermy
  • Sham Comparator: control
    continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
    Intervention: Device: Shortwave diathermy
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. Epub 2008 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
June 2004
May 2004   (final data collection date for primary outcome measure)

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
Female
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00199914
34/2003
No
Manee Rattanachaiyanont, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Manee Rattanachaiyanont, M.D. Mahidol University
Mahidol University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP