Back to resultsContralateral Acupuncture in the Treatment of Chronic Shoulder Pain
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Control
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring shoulder pain, acupuncture
Eligibility 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
Sites / Locations
- Province Hospital of Integrative Chinese and Western Medicine, Sichuan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture
Waiting list
Arm Description
Experimental group
Control group
Outcomes
Primary Outcome Measures
Visual analogue scale (VAS)
Pain assessment
Secondary Outcome Measures
The MOS item short from health survey (SF-36)
Quality of life assessment
Constant-Murley score
shoulder motion score
DASH score
Full Information
NCT ID
NCT01733914
First Posted
November 21, 2012
Last Updated
April 12, 2015
Sponsor
Peking University
Collaborators
University of Maryland
1. Study Identification
Unique Protocol Identification Number
NCT01733914
Brief Title
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
Official Title
Phase II Study of Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
University of Maryland
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
shoulder pain, acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Experimental group
Arm Title
Waiting list
Arm Type
Sham Comparator
Arm Description
Control group
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
Pain assessment
Time Frame
before and 2, 4, 8 and 16 weeks after treatment start
Secondary Outcome Measure Information:
Title
The MOS item short from health survey (SF-36)
Description
Quality of life assessment
Time Frame
before and 8 and 16 weeks after treatment start
Title
Constant-Murley score
Description
shoulder motion score
Time Frame
before and 2, 4, 8 and 16 weeks after treatment start
Title
DASH score
Time Frame
before and 2, 4, 8 and 16 weeks after treatment start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Yi, PhD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Province Hospital of Integrative Chinese and Western Medicine, Sichuan
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26795764
Citation
Zhang H, Sun J, Wang C, Yu C, Wang W, Zhang M, Lao L, Yi M, Wan Y. Randomised controlled trial of contralateral manual acupuncture for the relief of chronic shoulder pain. Acupunct Med. 2016 Jun;34(3):164-70. doi: 10.1136/acupmed-2015-010947. Epub 2016 Jan 21.
Results Reference
derived
Learn more about this trial
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
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