The Effects of Collateral Meridian Therapy for Knee Osteoarthritis Pain Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
ClinicalTrials.gov Identifier:
NCT01532531
First received: February 7, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention
Knee Osteoarthritis
Pain
Device: "GEMORE" Multi-Function Electrotherapy Stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Taichung Armed Forces General Hospital:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index, visual analogue scale [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 28
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided

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
Study First Received: February 7, 2012
Last Updated: August 14, 2012
Health Authority: Taiwan: Department of Health
United States: Federal Government

Keywords provided by Taichung Armed Forces General Hospital:
Collateral Meridian Therapy
Knee Osteoarthritis

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

ClinicalTrials.gov processed this record on July 24, 2014