Abstract
BackgroundPractitioners of complementary and alternative medicine have suggested that acupuncture could alleviate poststroke shoulder pain, based on the clinical evidence. This study protocol is aimed at showing the effectiveness and safety of electroacupuncture therapy for stroke survivors with shoulder pain.MethodsAfter assessing their eligibility, 60 stroke survivors with shoulder pain will be enrolled from two traditional Korean medicine hospitals and randomly divided into either the verum or the sham electroacupuncture (EA) group with a 1:1 ratio. The participants will receive 9 sessions of EA procedures for 3 weeks. The verum EA consists of needling on 6 unilateral acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) with electronic stimulation. A non-penetrating Park sham device and fake electronic stimulation will be used in the sham group on the same acupoints. Patients and outcome assessors will be blinded throughout the entire study. A visual analog scale will be used primarily for the evaluation, and pain rating scale, Fugl-Meyer assessment for upper extremity, modified Ashworth scale, manual muscle test, passive range of motion test, Korean version of a modified Barthel index, and Korean version of the Beck depression inventory will be also be measured. A blinding index will be assessed. For safety, adverse events will be recorded. Data will be statistically analyzed by two-sample t-test or Wilcoxon rank sum test for efficacy and a chi-squared test or Fisher’s exact test for safety, at 5% of significance level.DiscussionWe expect this double-center, randomized, sham-controlled, patient- and assessor-blinded parallel trial to explore the effectiveness and safety of EA therapy, compared with sham EA, for poststroke shoulder pain.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03086863
Highlights
Practitioners of complementary and alternative medicine have suggested that acupuncture could alleviate poststroke shoulder pain, based on the clinical evidence
Design, and setting of the study Primary objective and study hypothesis This clinical trial is primarily aimed at evaluating the effectiveness and safety of 3-week EA therapies, compared to sham comparator, for patients with shoulder pain that is rated on the visual analog scale (VAS) as ≥4 after a stroke, such as an intracerebral hemorrhage or infarction
Acupuncture therapies have been clinically studied, and based on the evidence from those studies, clinical practice guidelines have been published for general rehabilitation [30] or specific conditions of stroke survivors [31, 32]
Summary
60 stroke survivors with shoulder pain will be enrolled from two traditional Korean medicine hospitals and randomly divided into either the verum or the sham electroacupuncture (EA) group with a 1:1 ratio. The verum EA consists of needling on 6 unilateral acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) with electronic stimulation. A nonpenetrating Park sham device and fake electronic stimulation will be used in the sham group on the same acupoints. Data will be statistically analyzed by two-sample t-test or Wilcoxon rank sum test for efficacy and a chi-squared test or Fisher’s exact test for safety, at 5% of significance level
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