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Electroacupuncture for Poststroke Patients With Shoulder Pain

NCT03086863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-12-02

No results posted yet for this study

Summary

This is a multicenter, randomized, sham-controlled, patient- and assessor-blinded, and parallel trial to explore the effectiveness and safety of electroacupuncture (EA) therapy, compared with sham EA, for poststroke shoulder pain.

Conditions

  • Stroke
  • Shoulder Pain
  • Stroke, Complication
  • Cerebral Infarction
  • Cerebral Hemorrhage

Interventions

DEVICE

electroacupuncture

All the patients in verum electroacupuncture group will receive acupuncture on the six adjacent acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) in unilateral side. Acupuncture needles (stainless steel, 0.25 mm × 40 mm, Dong Bang Acupuncture Inc., Republic of Korea) will be inserted 10-15 mm in depth and de qi sensation will be elicited. Park sham guide tubes will be used in verum group, too. Low frequency stimulate (STN-111, Stratek, Republic of Korea) will be connected to the tips of needles to provide electrical stimulation at middle frequency (30 Hz). Needles with electrical stimulation will be retained for 20 minutes. Patients should take this procedure 3 times a week for 3 weeks (9 sessions in total).

DEVICE

sham electroacupuncture

We selected a non-penetrating sham needling, i.e., Park sham device, which has been developed and validated in preceding studies as comparison. On the exactly same 6 acupoints as verum electroacupuncture group, needles will be installed with Park sham guide tubes and the same electrical stimulators will be connected the tips of needles. Since the needles do not penetrate the skin, the stimulation is not electrically conducted. To be sure of patient blinding, the low frequency stimulate will be turned on with the same frequency (30 Hz), which makes a fake noise, resulting in letting patients believe that they are taking real electroacupuncture therapy for 20 minutes. Sham group will also 9 session for 3 weeks (3 sessions a week).

Sponsors & Collaborators

  • Wonkwang University Gwangju Medical Center

    collaborator UNKNOWN

  • National Rehabilitation Center, Seoul, Korea

    collaborator OTHER_GOV

  • Kyunghee University

    lead OTHER

Principal Investigators

  • Euiji Lee, Ph.D. · Kyunghee University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2017-11-29
Completion
2017-11-29

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086863 on ClinicalTrials.gov