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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650207
Other study ID # CCH-110410
Secondary ID
Status Completed
Phase N/A
First received July 12, 2012
Last updated July 25, 2012
Start date July 2011
Est. completion date June 2012

Study information

Verified date July 2012
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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
TENS

sham acupuncture


Locations

Country Name City State
Taiwan Changhua Christian Hospital Taiwan Changhua

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary shoulder pain degrees pain VAS in passive shoulder ROM 10 days after first intervention Yes
Secondary shoulder ROM passive shoulder ROM (abduction, ER) 10 days after first intervention Yes