Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

This study has been completed.
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: May 18, 2014
Last verified: May 2014
  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:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Visual analogue scale (VAS) [ Time Frame: before and 2, 4, 8 and 16 weeks after treatment start ] [ Designated as safety issue: No ]
    Pain assessment


Secondary Outcome Measures:
  • The MOS item short from health survey (SF-36) [ Time Frame: before and 8 and 16 weeks after treatment start ] [ Designated as safety issue: No ]
    Quality of life assessment

  • Constant-Murley score [ Time Frame: before and 2, 4, 8 and 16 weeks after treatment start ] [ Designated as safety issue: No ]
    shoulder motion score

  • DASH score [ Time Frame: before and 2, 4, 8 and 16 weeks after treatment start ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2011
Study Completion Date: August 2013
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
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: NCT01733914

Locations
China, Sichuan
Province Hospital of Integrative Chinese and Western Medicine, Sichuan
Chengdu, Sichuan, China, 100191
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: May 18, 2014
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 July 20, 2014