Clinical trial NCT03086863: Electroacupuncture for Poststroke Patients With Shoulder Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Shoulder Pain
Stroke, Complication
Cerebral Infarction
Cerebral Hemorrhage
Keywords: electroacupuncture
randomized controlled trial
Lead sponsor: Kyunghee University
Sponsor class: OTHER
Collaborators: name: Wonkwang University Gwangju Medical Center
name: National Rehabilitation Center, Seoul, Korea
First posted: 2017-03-22
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean difference of visual analogue scale (VAS) between baseline and endpoint
timeFrame: 3 weeks
Secondary outcomes:
measure: before-after change of visual analogue scale (VAS) (intragroup effect)
timeFrame: 1~3 weeks
measure: Mean difference of pain rating scale (PRS) between baseline and endpoint
timeFrame: 3 weeks
measure: Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint
timeFrame: 3 weeks
measure: Mean difference of passive ranges of motion (PROM) between baseline and endpoint
timeFrame: 3 weeks
measure: Mean difference of manual muscle test (MMT) between baseline and endpoint
timeFrame: 3 weeks
measure: Mean difference of modified Ashworth scale (MAS) between baseline and endpoint
timeFrame: 3 weeks
measure: Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint
timeFrame: 3 weeks
measure: Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint
timeFrame: 3 weeks
measure: mean difference of the occurrence numbers of adverse events
timeFrame: 3 times per week, 3 weeks, through study completion,
Other outcomes:
measure: new Blinding index (BI)
timeFrame: 3 weeks (only at the end of the study)
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
Study officials:
affiliation: Kyunghee University
name: Euiji Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SH, Lim SM. Acupuncture for Poststroke Shoulder Pain: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2016;2016:3549878. doi: 10.1155/2016/3549878. Epub 2016 Jul 31.
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citation: Kim HS, Her JG, Ko JY, Park DS, Woo JH, You YY, Choi YE. Reliability, concurrent validity, and responsiveness of the Fugl-Meyer assessment (FMA) for hemiplegic patients. Journal of Physical Therapy Science 24(9):893-899, 2012.
citation: Mendell JR, Florence J. Manual muscle testing. Muscle Nerve. 1990;13 Suppl:S16-20. doi: 10.1002/mus.880131307. No abstract available.
citation: Gregson JM, Leathley M, Moore AP, Sharma AK, Smith TL, Watkins CL. Reliability of the Tone Assessment Scale and the modified Ashworth scale as clinical tools for assessing poststroke spasticity. Arch Phys Med Rehabil. 1999 Sep;80(9):1013-6. doi: 10.1016/s0003-9993(99)90053-9.
citation: Jung HY, Park BK, Shin HS, Kang YK, Pyun SB, Paik NJ, Kim SH, Kim TH, Han TR. Development of the Korean version of modified barthel index (K-MBI): multi-center study for subjects with Stroke. Journal of Korean Acamedy of Rehabilitation Medicine 31(3):283-297, 2007. (Korean)
citation: Rhee MK, Lee YH, Park SH, Sohn CH, Chung YC, Hong SK, Lee BK, Chang P, Yoon AR. A stadardization study of beck depression inventory Ⅰ - Korean version (K-BDI): reliability and factor analysis. The Korean Journal of Psychopathology 4(1):77-95, 1995. (Korean)
citation: Rhee MK, Lee YH, Jung HY, Chio JH, Kim SH, Kim YK, Lee SK. A stadardization study of beck depression inventory Ⅱ - Korean version (K-BDI): validity. The Korean Journal of Psychopathology 4(1):96-104, 1995 . (Korean)
citation: Wang KF, Zhang LJ, Lu F, Lu YH, Yang CH. Can Ashi points stimulation have specific effects on shoulder pain? A systematic review of randomized controlled trials. Chin J Integr Med. 2016 Jun;22(6):467-72. doi: 10.1007/s11655-015-2107-4. Epub 2015 Jun 30.
citation: Shin S, Yang SP, Yu A, Yoo J, Lim SM, Lee E. Effectiveness and safety of electroacupuncture for poststroke patients with shoulder pain: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial. BMC Complement Altern Med. 2019 Mar 12;19(1):58. doi: 10.1186/s12906-019-2468-x.