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StrokeEAPSSPNCT03086863

Electroacupuncture for Poststroke Patients With Shoulder Pain

A study testing electroacupuncture in people with Stroke and Shoulder Pain, run by Kyunghee University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke, Shoulder Pain, Stroke, Complication
What is being tested?
electroacupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteSouth Korea
Study dates
3 Apr 2017to 29 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Korean Medicine Hospital

    Seoul, 156-853

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
electroacupuncture, sham electroacupuncture
Keywords
electroacupuncture, randomized controlled trial
Medical subject headings
Stroke, Shoulder Pain, Cerebral Infarction, Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroacupunctureDevice

    Also called verum EA

    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).

  • sham electroacupunctureDevice

    Also called sham EA

    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).

Study groups in NCT03086863
Study groupRoleWhat they receive
verum electroacupunctureExperimental* 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.
Receives: Device: electroacupuncture
sham electroacupunctureSham 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.
Receives: Device: sham electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 weeks

Secondary outcomes (9)

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

    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.

    Measured: 1~3 weeks

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

    PRS is a patient-rated outcome to assess pain with 4 items for intensity (0-10 points), frequency (0-5 points), duration (0-5 points) and aggravating factors (0-5 points). The pain score is the product of the intensity point and the sum of frequency, duration, aggravating factors points (0-150 points in total).

    Measured: 3 weeks

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

    FMA-UE assesses physical performance of upper extremity following stroke. The original FMA scale includes 4 domains of motor function, sensation qualities, passive range of motion, and joint pain with 3-point items ('cannot perform' for 0, 'perform partially' for 1, and 'perform fully' for 2). We are going to measure only 8 items for upper extremity (shoulder retraction, elevation, abduction, abduction to 90°, adduction/internal rotation, external rotation, flexion 0-90°, and flexion 90-180°)

    Measured: 3 weeks

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

    PROM for shoulder flexion, abduction, and extension will be measured with goniometer. The maximum degrees under passive movement of shoulder unless patients suffer from pain will be tested.

    Measured: 3 weeks

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

    MMT assesses muscle strength in poststroke shoulder injury. Assessors will rate on a grade of 0 (no contraction at all) to 5 (complete range of motion against gravity with maximum resistance) for hemiplegic shoulder.

    Measured: 3 weeks

  6. Mean difference of modified Ashworth scale (MAS) between baseline and endpoint

    MAS is a clinical rating scale to measure tonal abnormality after stroke. Assessors should grade from 0, meaning no increase in muscle tone, to 5, meaning that rigid shoulder on flexion or extension.

    Measured: 3 weeks

  7. Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint

    K-MBI is an ordinal scale used to measure performance in activities of daily living. Ten items (personal hygiene, bathing, feeding, toilet use, stair climbing, dressing, bowel control, bladder control, walking, and chair/bed transfers) will be graded between 1 (completely dependent on others to perform) and 5 (completely independent on others to perform), respectively, and it scores up to 100 points in total.

    Measured: 3 weeks

  8. Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint

    K-BDI is a patient-rated outcome with 21 items, 0 to 3 points of each item. The higher the total score is, the severe the depressive level is.

    Measured: 3 weeks

  9. mean difference of the occurrence numbers of adverse events

    At every visit, assessors will ask a post-interventional question about adverse events. The number of adverse events will be recorded for each group.

    Measured: 3 times per week, 3 weeks, through study completion,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study start3 Apr 2017
  3. Primary completion29 Nov 2017
  4. Study completion29 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086863
Sponsor's protocol ID
2017005
Acronym
EAPSSP
Status last verified
Nov 2017
First submitted
26 Feb 2017
Last updated
2 Dec 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27547224

  • 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.

    PubMed 15020033

  • 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.

    PubMed 12512790

  • 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.

    PubMed 6226917

  • 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)

  • 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.

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

    PubMed 2233877

  • 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.

    PubMed 10489001

  • 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)

  • 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)

  • 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)

  • 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.

    PubMed 26129899

  • 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.

    PubMed 30866914

Questions about this trial

What is this clinical trial studying?

A study testing electroacupuncture in people with Stroke and Shoulder Pain, run by Kyunghee University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean difference of visual analogue scale (VAS) between baseline and endpoint (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03086863, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.

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