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Acupuncture for Hemiplegic Shoulder Pain

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ClinicalTrials.gov Identifier: NCT01650207
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Ta-Sen Wei,MD, Changhua Christian Hospital

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Shoulder Pain in Hemiplegic Side After Stroke Procedure: acupuncture Procedure: TENS Procedure: sham acupuncture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. shoulder pain degrees [ Time Frame: 10 days after first intervention ]
    pain VAS in passive shoulder ROM


Secondary Outcome Measures :
  1. shoulder ROM [ Time Frame: 10 days after first intervention ]
    passive shoulder ROM (abduction, ER)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650207


Locations
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Taiwan
Changhua Christian Hospital
Taiwan, Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
Investigators
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Principal Investigator: Tasen Wei Physical Medical and Rehabilitation, Changhua Christian Hospital
More Information
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Responsible Party: Ta-Sen Wei,MD, Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01650207    
Other Study ID Numbers: CCH-110410
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012
Keywords provided by Ta-Sen Wei,MD, Changhua Christian Hospital:
electroacupuncture
TENS
shoulder disorder
hemiplegia
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations