The Effects of Collateral Meridian Therapy for Knee Osteoarthritis Pain Management

NCT01532531 | Completed DMC

• 1 other identifier: TC98-2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Pain

Keywords

Collateral Meridian Therapy; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index, visual analogue scale

  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.

  3 months

Study Arms (2)

Collateral Meridian Therapy

EXPERIMENTAL

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

Control (CT) group

NO INTERVENTION

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.

Interventions

"GEMORE" Multi-Function Electrotherapy Stimulator DEVICE

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.

Collateral Meridian Therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Armed Forces General Hospital: lead

Study Sites (1)

Taichung Armed Forces General Hospital

Taichung, 411, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chih-Shung Wong, PhD

  Cathay General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 14, 2012
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

TW (1)