NCT01733914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 14, 2015

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

November 21, 2012

Last Update Submit

April 12, 2015

Conditions

Shoulder Pain

Keywords

shoulder painacupuncture

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS)

    Pain assessment

    before and 2, 4, 8 and 16 weeks after treatment start

Secondary Outcomes (3)

  • The MOS item short from health survey (SF-36)

    before and 8 and 16 weeks after treatment start

  • Constant-Murley score

    before and 2, 4, 8 and 16 weeks after treatment start

  • DASH score

    before and 2, 4, 8 and 16 weeks after treatment start

Study Arms (2)

Acupuncture

EXPERIMENTAL

Experimental group

Procedure: Acupuncture

Waiting list

SHAM COMPARATOR

Control group

Other: Control

Interventions

AcupuncturePROCEDURE

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.

Acupuncture
ControlOTHER

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.

Waiting list

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uni-lateral shoulder pain for 6 weeks to 2 years
  • VAS score ≤ 50
  • years of age
  • Positive Neer's or Hawkins' signs
  • Accept the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Province Hospital of Integrative Chinese and Western Medicine, Sichuan

Chengdu, Sichuan, 100191, China

Location

Related Publications (1)

  • 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.

    PMID: 26795764DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ming Yi, PhD

    Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

September 1, 2011

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

April 14, 2015

Record last verified: 2014-05

Locations

CN(1)