Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733914
• Other study ID #: 2007CB512501
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2012
• Last updated: April 12, 2015
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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.

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.

Locations

Country	Name	City	State
China	Province Hospital of Integrative Chinese and Western Medicine, Sichuan	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	University of Maryland

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS)	Pain assessment	before and 2, 4, 8 and 16 weeks after treatment start	No
Secondary	The MOS item short from health survey (SF-36)	Quality of life assessment	before and 8 and 16 weeks after treatment start	No
Secondary	Constant-Murley score	shoulder motion score	before and 2, 4, 8 and 16 weeks after treatment start	No
Secondary	DASH score		before and 2, 4, 8 and 16 weeks after treatment start	No