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Acupuncture for Hemiplegic Shoulder Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ta-Sen Wei,MD, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01650207
First received: July 12, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Shoulder Pain in Hemiplegic Side After Stroke
 Procedure: acupuncture
Procedure: TENS
Procedure: sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • shoulder pain degrees [ Time Frame: 10 days after first intervention ] [ Designated as safety issue: Yes ]
    pain VAS in passive shoulder ROM


Secondary Outcome Measures:
  • shoulder ROM [ Time Frame: 10 days after first intervention ] [ Designated as safety issue: Yes ]
    passive shoulder ROM (abduction, ER)


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650207

Locations
Taiwan
Changhua Christian Hospital
Taiwan, Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
Investigators
Principal Investigator: Tasen Wei Physical Medical and Rehabilitation, Changhua Christian Hospital
  More Information

No publications provided

Responsible Party: Ta-Sen Wei,MD, Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01650207     History of Changes
Other Study ID Numbers: CCH-110410
Study First Received: July 12, 2012
Last Updated: July 25, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Changhua Christian Hospital:
electroacupuncture
TENS
shoulder disorder
hemiplegia

Additional relevant MeSH terms:
Shoulder Pain
Stroke
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013