At a glance

ClinicalIndex Comparison Record

N/ACompleted· 45 enrolled

Drug / intervention

electroacupuncture +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03086863

NCT03086863N/ACompleted

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Effectiveness and Safety of Electroacupuncture for Poststroke Patients With Shoulder Pain: Study Protocol for a Multicenter, Randomized, Patient and Assessor Blinded, Sham Controlled, Parallel, Clinical Trial

Kyunghee University·interventional·Posted Mar 22, 2017·Updated Dec 2, 2017

In Brief

A clinical study evaluating electroacupuncture and sham electroacupuncture for Stroke and 4 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

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

CountriesSouth Korea

CollaboratorsWonkwang University, National Rehabilitation Center, Seoul, Korea

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

First PostedMar 2017

Enrollment StartApr 2017

Primary CompletionNov 2017

TodayJul 2026

First PostedMar 22, 2017

Enrollment StartApr 3, 2017

Primary CompletionNov 29, 2017

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 9.3 years ago

Interventions

electroacupuncturedevice

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).

sham electroacupuncturedevice

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).