Electroacupuncture for Poststroke Patients With Shoulder Pain

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Stroke, Shoulder Pain, Stroke, Complication, Cerebral Infarction, Cerebral Hemorrhage

Intervention / Treatment
-----------------
* Device: electroacupuncture
* Device: sham electroacupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: verum electroacupuncture<br>Electroacupuncture on LI4, LI15, TE14, SI9, SI11, and GB21, unilaterally Needle insertion by 10-15 mm and de qi sensation Park sham guide tubes Low frequency electronic stimulation (30 Hz) Retention for 20 minutes. | Device: electroacupuncture<br>* 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).<br>* Other names: verum EA;|
| Sham Comparator: sham electroacupuncture<br>Park sham device on on LI4, LI15, TE14, SI9, SI11, and GB21, unilaterally Needle installation without penetration Park sham guide tubes Low frequency electronic stimulation (30 Hz) for a fake noise without conduction Retention for 20 minutes. | Device: sham electroacupuncture<br>* 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).<br>* Other names: sham EA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| before-after change of visual analogue scale (VAS) (intragroup effect) | 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. | 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). | 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°) | 3 weeks | 
| Mean difference of passive ranges of motion (PROM) between baseline and endpoint | PROM for shoulder flexion, abduction, and extension will be measured with goniometer. The maximum degrees under passive movement of shoulder unless patients suffer from pain will be tested. | 3 weeks | 
| Mean difference of manual muscle test (MMT) between baseline and endpoint | MMT assesses muscle strength in poststroke shoulder injury. Assessors will rate on a grade of 0 (no contraction at all) to 5 (complete range of motion against gravity with maximum resistance) for hemiplegic shoulder. | 3 weeks | 
| Mean difference of modified Ashworth scale (MAS) between baseline and endpoint | MAS is a clinical rating scale to measure tonal abnormality after stroke. Assessors should grade from 0, meaning no increase in muscle tone, to 5, meaning that rigid shoulder on flexion or extension. | 3 weeks | 
| Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint | K-MBI is an ordinal scale used to measure performance in activities of daily living. Ten items (personal hygiene, bathing, feeding, toilet use, stair climbing, dressing, bowel control, bladder control, walking, and chair/bed transfers) will be graded between 1 (completely dependent on others to perform) and 5 (completely independent on others to perform), respectively, and it scores up to 100 points in total. | 3 weeks | 
| Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint | K-BDI is a patient-rated outcome with 21 items, 0 to 3 points of each item. The higher the total score is, the severe the depressive level is. | 3 weeks | 
| mean difference of the occurrence numbers of adverse events | At every visit, assessors will ask a post-interventional question about adverse events. The number of adverse events will be recorded for each group. | 3 times per week, 3 weeks, through study completion, | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electroacupuncture, randomized controlled trial