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
Results First Received: May 19, 2013  
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
Conditions: Osteoarthritis, Knee
Menopause
Intervention: Device: Shortwave diathermy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A randomized and double blind placebo controlled equivalence trial was carried out in the out-patient clinic, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University from January to June 2004.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients had primary knee OA and without the following conditions: inability to walk, severe joint instability, history of previous SWD treatment, intra-articular injection within 3 months, metallic implant around knee joint, suspicious of malignancy around knee joint, significant cardiovascular disease.

Reporting Groups
  Description
Shortwave Diathermy continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Control continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Participant Flow:   Overall Study
    Shortwave Diathermy     Control  
STARTED     53     60  
COMPLETED     50     54  
NOT COMPLETED     3     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Shortwave Diathermy continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Control continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Total Total of all reporting groups

Baseline Measures
    Shortwave Diathermy     Control     Total  
Number of Participants  
[units: participants]
  53     60     113  
Age  
[units: years]
Mean ± Standard Deviation
  63.32  ± 7.61     62.48  ± 8.47     62.88  ± 8.05  
Gender  
[units: participants]
     
Female     53     60     113  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Thailand     53     60     113  



  Outcome Measures

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

2.  Secondary:   Gait Speed (Calculated From the Time Spending for 100-meter Walk)   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Global Improvement   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Patient's Satisfaction to the Treatment   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Adverse Events   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Manee Rattanachaiyanont
Organization: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
phone: +66-2419-4657
e-mail: manee.rat@mahidol.ac.th


Publications of Results:

Responsible Party: Manee Rattanachaiyanont, 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