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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199914
First Posted: September 20, 2005
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manee Rattanachaiyanont, Mahidol University
  Purpose
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.

Condition Intervention Phase
Osteoarthritis, Knee Menopause Device: Shortwave diathermy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Manee Rattanachaiyanont, Mahidol University:

Primary Outcome Measures:
  • The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures:
  • Gait Speed (Calculated From the Time Spending for 100-meter Walk) [ Time Frame: 3 weeks ]
  • Global Improvement [ Time Frame: 3 weeks ]
  • Patient's Satisfaction to the Treatment [ Time Frame: 3 weeks ]
  • Adverse Events [ Time Frame: 3 weeks ]

Enrollment: 113
Study Start Date: January 2004
Study Completion Date: June 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Device: Shortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Sham Comparator: control
continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Device: Shortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

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.

  Eligibility

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199914


Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Manee Rattanachaiyanont, M.D. Mahidol University
  More Information

Publications:
Responsible Party: Manee Rattanachaiyanont, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00199914     History of Changes
Other Study ID Numbers: 34/2003
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: May 19, 2013
Results First Posted: November 8, 2013
Last Update Posted: November 8, 2013
Last Verified: September 2013

Keywords provided by Manee Rattanachaiyanont, Mahidol University:
Diathermy
Short-wave therapy
Osteoarthritis
Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases