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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mahidol University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 12, 2005
Results First Received: May 19, 2013
Last Updated: September 6, 2013
Health Authority: Thailand: Ministry of Public Health

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

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

ClinicalTrials.gov processed this record on August 26, 2014