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The Effects of Collateral Meridian Therapy for Knee Osteoarthritis Pain Management

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ClinicalTrials.gov Identifier: NCT01532531
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Huei-Chi Horng, MD, Taichung Armed Forces General Hospital

Brief Summary:
Collateral meridian therapy (CMT) is a recently developed technique according to traditional Chinese medicine (TCM) experiences, differing from traditional Chinese acupuncture in numerous manners. CMT involves the manipulation of a distant non-painful collateral meridian, thereby facilitating the dissipation of pain. The technique avoids direct stimulation of the involved meridian, which enhances patient tolerability and prevents further injury to the disease and painful areas. Numerous clinical cases have reported the effectiveness of CMT in pain management. This study tests whether CMT is effective for treating knee OA pain and functional recovery.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Pain Device: "GEMORE" Multi-Function Electrotherapy Stimulator Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Collateral Meridian Therapy
The CMT group patients received, according to the CMT protocol described previously, CMT at the selected points with the CMT Electrotherapy Stimulator ("GEMORE" Multi-Function Electrotherapy Stimulator; GM390TE, GEMORE Co Ltd, Taiwan) to treat the affected OA knee. The 6-minute treatment (electrotherapy was set at 40 Hz biphasic and 30 mA) comprises reduction and enhancement procedures on the specific points. Each patient received CMT twice per week for three weeks during the study.
Device: "GEMORE" Multi-Function Electrotherapy Stimulator
The Collateral Meridian Therapy (CMT) group patients received, according to the CMT protocol described previously (5), CMT at the selected points with the CMT Electrotherapy Stimulator ("GEMORE" Multi-Function Electrotherapy Stimulator; GM390TE, GEMORE Co Ltd, Taiwan) to treat the affected OA knee. The 6-minute treatment (electrotherapy was set at 40 Hz biphasic and 30 mA) comprises reduction and enhancement procedures on the specific points. Each patient received CMT twice per week for three weeks during the study.
No Intervention: Control (CT) group
Patients in the CT group received electronic lead-patches applied on the treatment points, which was identical to what the CMT patients received, also for 6 minutes, though no electric stimulation was applied.



Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index, visual analogue scale [ Time Frame: 3 months ]
    ain intensity at activity, quantified with a 100 mm VAS and pain disability measured with the Western Ontario and McMasters Universities Osteoarthritis Index. The VAS and WOMAC scores were measured immediately by independent staff before the first treatment, and subsequently at one, two, three weeks, and three months after the first treatment.



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Knee OA patients aged 60 years or older
  • Visual analogue scale (VAS) pain score higher than 30 mm on a 100-mm scale over the medial side of the knee while walking

Exclusion Criteria:

  • Individuals who had undergone total knee arthroplasty, exhibited uncontrolled hypertension, had a history of cardiovascular disease, or suffered from neurological disorders that affected lower extremity functions were excluded from the study.
  • Patients who received conflicting or ongoing interventions such as acupuncture, hyaluronan injections, intra-articular corticosteroid, and transcutaneous electrical nerve stimulation and thermotherapy were also excluded.

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): NCT01532531


Locations
Taiwan
Taichung Armed Forces General Hospital
Taichung, Taiwan, 411
Sponsors and Collaborators
Taichung Armed Forces General Hospital
Investigators
Study Director: Chih-Shung Wong, PhD Cathay General Hospital

Responsible Party: Huei-Chi Horng, MD, Principal Investigator, Taichung Armed Forces General Hospital
ClinicalTrials.gov Identifier: NCT01532531     History of Changes
Other Study ID Numbers: TC98-2
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Huei-Chi Horng, MD, Taichung Armed Forces General Hospital:
Collateral Meridian Therapy
Knee Osteoarthritis

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