Electroacupuncture for Poststroke Patients With Shoulder Pain

Kyunghee University45 enrolled

Overview

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.

This study is aimed at showing the effectiveness and safety of electroacupuncture therapy for the stroke survivors with shoulder pain. 60 stroke survivors with shoulder pain will be enrolled in two traditional Korean medicine hospitals and randomly divided into either of verum or sham electroacupuncture group with 1:1 of allocation ratio. The participants will receive 9 sessions of electroacupuncture procedures for 3 weeks. Patients and outcome assessors will be blinded from the beginning to the study completion. Visual analogue scale will be primarily evaluated, and pain rating scale, Fugl-Meyer assessment upper extremity, modified Ashworth scale, manual muscle test, passive range of motion, Korean version of modified Barthel index, and Korean version of Beck depression inventory will be measured, too. Blinding index will be assessed. For safety, adverse events will be collected.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Shoulder Pain Stroke, Complication Cerebral Infarction Cerebral Hemorrhage

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).

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosed with cerebral hemorrhage or infarction examined by computed tomography (CT) magnetic resonance imaging (MRI) at least 2 weeks or more ago; * complaining hemiplegic shoulder pain of VAS ≥4; * agreeing that any treatments, including analgesics, for hemiplegic shoulder pain will not be changed from the previous 2 weeks prior to the enrollment until the last evaluation, if applicable; * fully explained about the clinical research and sign the informed consents. Exclusion Criteria: * disorders, traumatic injury, or surgery of shoulders even before their stroke; * pacemakers, embedded neural stimulator, cardiac arrhythmia, epilepsy, peripheral neural injury on their medical history; * psychiatric disorders; * cancer within the past 5 years, regardless of its prognosis and location; * cognitive impairment that interferes with clinical assessment; * hypersensitivity or fears to acupuncture; * bleeding disorders (e.g. hemophilia or von Willebrand disease, etc.), * pregnancy, * difficulty in communicating with researchers, or * any other conditions who are considered inappropriate for participating in the trial by experienced practitioners.

Locations (1)

Kyung Hee University Korean Medicine Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Mean difference of visual analogue scale (VAS) between baseline and endpoint

VAS is a patient-rated outcome with a 10-cm line representing 'not painful at all' for zero and 'most painful' for ten. Patient marks x on the line by oneself, based on how intense he/she thinks the pain is and assessor measures the length from zero point to x mark, which is the pain score.

Time frame: 3 weeks

Secondary Outcomes

before-after change of visual analogue scale (VAS) (intragroup effect)

Time frame: 1~3 weeks

Mean difference of pain rating scale (PRS) between baseline and endpoint

PRS is a patient-rated outcome to assess pain with 4 items for intensity (0-10 points), frequency (0-5 points), duration (0-5 points) and aggravating factors (0-5 points). The pain score is the product of the intensity point and the sum of frequency, duration, aggravating factors points (0-150 points in total).

Time frame: 3 weeks

Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint

FMA-UE assesses physical performance of upper extremity following stroke. The original FMA scale includes 4 domains of motor function, sensation qualities, passive range of motion, and joint pain with 3-point items ('cannot perform' for 0, 'perform partially' for 1, and 'perform fully' for 2). We are going to measure only 8 items for upper extremity (shoulder retraction, elevation, abduction, abduction to 90°, adduction/internal rotation, external rotation, flexion 0-90°, and flexion 90-180°)

Time frame: 3 weeks

Mean difference of passive ranges of motion (PROM) between baseline and endpoint

Data from ClinicalTrials.gov

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