Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

April 12, 2015 updated by: Ming Yi, PhD, principle investigator, Peking University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 100191
        • Province Hospital of Integrative Chinese and Western Medicine, Sichuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Sham Comparator: Waiting list
Control group
Other: Control
Patients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: before and 2, 4, 8 and 16 weeks after treatment start
Pain assessment
before and 2, 4, 8 and 16 weeks after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The MOS item short from health survey (SF-36)
Time Frame: before and 8 and 16 weeks after treatment start
Quality of life assessment
before and 8 and 16 weeks after treatment start
Constant-Murley score
Time Frame: before and 2, 4, 8 and 16 weeks after treatment start
shoulder motion score
before and 2, 4, 8 and 16 weeks after treatment start
DASH score
Time Frame: before and 2, 4, 8 and 16 weeks after treatment start
before and 2, 4, 8 and 16 weeks after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

University of Maryland

Investigators

  • Principal Investigator: Ming Yi, PhD, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 12, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007CB512501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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