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.
- Sham electroacupuncture Device
Other Names: sham EA Intervention Desc: 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). ARM 1: Kind: Experimental Label: sham electroacupuncture Description: 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.
- Electroacupuncture Device
Other Names: verum EA Intervention Desc: 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). ARM 1: Kind: Experimental Label: verum electroacupuncture Description: 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.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Mean difference of visual analogue scale (VAS) between baseline and endpoint||3 weeks|
|Secondary||before-after change of visual analogue scale (VAS) (intragroup effect)||1~3 weeks|
|Secondary||Mean difference of pain rating scale (PRS) between baseline and endpoint||3 weeks|
|Secondary||Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint||3 weeks|
|Secondary||Mean difference of passive ranges of motion (PROM) between baseline and endpoint||3 weeks|
|Secondary||Mean difference of manual muscle test (MMT) between baseline and endpoint||3 weeks|
|Secondary||Mean difference of modified Ashworth scale (MAS) between baseline and endpoint||3 weeks|
|Secondary||Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint||3 weeks|
|Secondary||Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint||3 weeks|
|Secondary||mean difference of the occurrence numbers of adverse events||3 times per week, 3 weeks, through study completion,|