Electroacupuncture for Poststroke Patients With Shoulder Pain

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

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.

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.