Electroacupuncture for Poststroke Patients With Shoulder Pain

NCT03086863 | Completed

• 1 other identifier: 2017005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Shoulder Pain; Stroke, Complication; Cerebral Infarction; Cerebral Hemorrhage

Keywords

electroacupuncture; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• before-after change of visual analogue scale (VAS) (intragroup effect)

  1~3 weeks

• Mean difference of pain rating scale (PRS) between baseline and endpoint

  3 weeks

• Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint

  3 weeks

• Mean difference of passive ranges of motion (PROM) between baseline and endpoint

  3 weeks

• Mean difference of manual muscle test (MMT) between baseline and endpoint

  3 weeks

Other Outcomes (1)

• new Blinding index (BI)

  3 weeks (only at the end of the study)

Study Arms (2)

verum electroacupuncture

EXPERIMENTAL

* 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

sham electroacupuncture

SHAM COMPARATOR

* 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

Interventions

electroacupuncture DEVICE

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).

Also known as: verum EA

verum electroacupuncture

sham electroacupuncture DEVICE

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).

Also known as: sham EA

sham electroacupuncture

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyunghee University: lead
• Wonkwang University Gwangju Medical Center: collaborator
• National Rehabilitation Center, Seoul, Korea: collaborator

Study Sites (1)

Kyung Hee University Korean Medicine Hospital

Seoul, 156-853, South Korea

Location

Related Publications (13)

• 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.

  PMID: 27547224 BACKGROUND

• Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.

  PMID: 15020033 BACKGROUND

• Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med. 2002 Dec;20(4):168-74. doi: 10.1136/aim.20.4.168.

  PMID: 12512790 BACKGROUND

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 BACKGROUND

• Kim C, Kim C, Chun SI. Clinical value of a new self assessment method of pain. Journal of Korean Acamedy of Rehabilitation Medicine 22(2):305-311, 1998. (Korean)

  BACKGROUND

• 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.

  BACKGROUND

• Mendell JR, Florence J. Manual muscle testing. Muscle Nerve. 1990;13 Suppl:S16-20. doi: 10.1002/mus.880131307. No abstract available.

  PMID: 2233877 BACKGROUND

• 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.

  PMID: 10489001 BACKGROUND

• 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)

  BACKGROUND

• 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)

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 26129899 BACKGROUND

• 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.

  PMID: 30866914 DERIVED

MeSH Terms

Conditions

Stroke; Shoulder Pain; Cerebral Infarction; Cerebral Hemorrhage

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Necrosis; Intracranial Hemorrhages; Hemorrhage

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Euiji Lee, Ph.D.

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D. KMD.

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 22, 2017
• Study Start: April 3, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

KR (1)