Acupuncture for Hemiplegic Shoulder Pain

July 25, 2012 updated by: Ta-Sen Wei,MD, Changhua Christian Hospital

Shoulder pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed.

The aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (QOL) for stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Taiwan
    • Changhua
      • Taiwan, Changhua, Taiwan, 500
        • Changhua Christian Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke within 6 months from onset
  • Hemiplegia with shoulder pain (VAS > 2)

Exclusion Criteria:

  • previous pathology of the shoulder or cardiac pacemaker, and cognition problems

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: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EA group
To acupuncture the Juanyu (Li15) & Jugu (Li16) with sensation of de-qi, and then give 50 Hz electrical stimulation for 20 minutes.
Procedure: acupuncture

All participants were received regular rehabilitation program, and received different interventions.

treatment frequency: 20 minutes per session, once daily, 5 times a week for 2 weeks
EXPERIMENTAL: TENS group
The electrical patches were placed on the Juanyu (Li15) & Jugu (Li16) or Juanyu (Li15), Quchi (Li11), Shousanli (Li10) & Hegu (Li4), connected to a TENS apparatus and then give 50 Hz electrical stimulation for 20 minutes.
Procedure: TENS
SHAM_COMPARATOR: sham-acupuncutre
The Park's Sham Device were placed on the Juanyu (Li15) & Jugu (Li16).
Procedure: sham acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder pain degrees
Time Frame: 10 days after first intervention
pain VAS in passive shoulder ROM
10 days after first intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder ROM
Time Frame: 10 days after first intervention
passive shoulder ROM (abduction, ER)
10 days after first intervention

Collaborators and Investigators

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

Sponsor

Changhua Christian Hospital

Investigators

  • Principal Investigator: Tasen Wei, Physical Medical and Rehabilitation, Changhua Christian Hospital

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

July 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (ESTIMATE)

July 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCH-110410

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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