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Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

This study is currently recruiting participants.
Verified November 2012 by Peking University
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Ming Yi, PhD, principle investigator, Peking University
ClinicalTrials.gov Identifier:
NCT01733914
First received: November 21, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

According to traditional Chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. For example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. We hypothesize that stimulating acupoints contralateral to the pain site can successfully treat chronic shoulder pain.


Condition Intervention Phase
Shoulder Pain
 Procedure: Acupuncture
 Phase 2

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: Phase II Study of Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Visual analogue scale (VAS) [ Time Frame: up to 12 weeks after treatment ] [ Designated as safety issue: No ]
    Pain assessment


Secondary Outcome Measures:
  • The MOS item short from health survey (SF-36) [ Time Frame: before and 1, 2, 4 and 12 weeks after treatment ] [ Designated as safety issue: No ]
    Quality of life assessment

  • Constant-Murley score [ Time Frame: before and 1, 2, 4 and 12 weeks after treatment ] [ Designated as safety issue: No ]
    shoulder motion score


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Experimental group
 Procedure: Acupuncture
Acupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks.
No Intervention: Waiting list
Control group

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uni-lateral shoulder pain for 6 weeks to 2 years
  • VAS score ≤ 50
  • 25-65 years of age
  • Positive Neer's or Hawkins' signs
  • Accept the informed consent

Exclusion Criteria:

  • Shoulder pain of neurological origins
  • Shoulder pain of neck origins
  • Systematic arthritis
  • Wrist problems
  • Previous shoulder, arm, neck or chest fractures or surgeries
  • Mental diseases
  • Pregnancy
  • Inability to work for more than 3 months before treatment
  • Diabetes
  • Coagulative dysfunction
  • Corticosterone or physicotherapy experience on the affected shoulder in the last 6 months
  • Failure to accept the informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733914

Contacts
Contact: Ming Yi, Ph.D. 82801010 mingyi@bjmu.edu.cn

Locations
China, Sichuan
Province Hospital of Integrative Chinese and Western Medicine, Sichuan Recruiting
Chengdu, Sichuan, China, 100191
Sub-Investigator: Jungang Sun, MD            
Sponsors and Collaborators
Peking University
University of Maryland
Investigators
Principal Investigator: Ming Yi, PhD Peking University
  More Information

No publications provided

Responsible Party: Ming Yi, PhD, principle investigator, Dr, Peking University
ClinicalTrials.gov Identifier: NCT01733914     History of Changes
Other Study ID Numbers: 2007CB512501
Study First Received: November 21, 2012
Last Updated: November 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
shoulder pain
acupuncture

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013