Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

Sponsor

Peking University (Other)

Overall Status

Completed

CT.gov ID

NCT01733914

Collaborator

University of Maryland (Other)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Shoulder Pain	Procedure: Acupuncture Other: Control	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Visual analogue scale (VAS) [before and 2, 4, 8 and 16 weeks after treatment start]
Pain assessment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ming Yi, PhD, principle investigator, Dr, Peking University

ClinicalTrials.gov Identifier:

NCT01733914

Other Study ID Numbers:

2007CB512501

First Posted:

Nov 27, 2012

Last Update Posted:

Apr 14, 2015

Last Verified:

May 1, 2014

Keywords provided by Ming Yi, PhD, principle investigator, Dr, Peking University

shoulder pain

acupuncture

Additional relevant MeSH terms:

Shoulder Pain

Study Results

No Results Posted as of Apr 14, 2015