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Acupuncture for Hemiplegic Shoulder Pain

Primary Purpose

Shoulder Pain in Hemiplegic Side After Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
TENS
sham acupuncture
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain in Hemiplegic Side After Stroke focused on measuring electroacupuncture, TENS, shoulder disorder, hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

EA group

TENS group

sham-acupuncutre

Arm Description

To acupuncture the Juanyu (Li15) & Jugu (Li16) with sensation of de-qi, and then give 50 Hz electrical stimulation for 20 minutes.

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.

The Park's Sham Device were placed on the Juanyu (Li15) & Jugu (Li16).

Outcomes

Primary Outcome Measures

shoulder pain degrees
pain VAS in passive shoulder ROM

Secondary Outcome Measures

shoulder ROM
passive shoulder ROM (abduction, ER)

Full Information

First Posted
July 12, 2012
Last Updated
July 25, 2012
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01650207
Brief Title
Acupuncture for Hemiplegic Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain in Hemiplegic Side After Stroke
Keywords
electroacupuncture, TENS, shoulder disorder, hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EA group
Arm Type
Experimental
Arm Description
To acupuncture the Juanyu (Li15) & Jugu (Li16) with sensation of de-qi, and then give 50 Hz electrical stimulation for 20 minutes.
Arm Title
TENS group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham-acupuncutre
Arm Type
Sham Comparator
Arm Description
The Park's Sham Device were placed on the Juanyu (Li15) & Jugu (Li16).
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
TENS
Intervention Type
Procedure
Intervention Name(s)
sham acupuncture
Primary Outcome Measure Information:
Title
shoulder pain degrees
Description
pain VAS in passive shoulder ROM
Time Frame
10 days after first intervention
Secondary Outcome Measure Information:
Title
shoulder ROM
Description
passive shoulder ROM (abduction, ER)
Time Frame
10 days after first intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasen Wei
Organizational Affiliation
Physical Medical and Rehabilitation, Changhua Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Taiwan
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

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Acupuncture for Hemiplegic Shoulder Pain

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