Electroacupuncture for Poststroke Patients With Shoulder Pain (EAPSSP)

November 30, 2017 updated by: Lee Eui-ju, Kyunghee University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-853
        • Kyung Hee University Korean Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: verum electroacupuncture
  • 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
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).
Other Names:
  • verum EA
Sham Comparator: sham electroacupuncture
  • 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
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).
Other Names:
  • sham EA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference of visual analogue scale (VAS) between baseline and endpoint
Time Frame: 3 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
before-after change of visual analogue scale (VAS) (intragroup effect)
Time Frame: 1~3 weeks
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.
1~3 weeks
Mean difference of pain rating scale (PRS) between baseline and endpoint
Time Frame: 3 weeks
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).
3 weeks
Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint
Time Frame: 3 weeks
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°)
3 weeks
Mean difference of passive ranges of motion (PROM) between baseline and endpoint
Time Frame: 3 weeks
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.
3 weeks
Mean difference of manual muscle test (MMT) between baseline and endpoint
Time Frame: 3 weeks
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.
3 weeks
Mean difference of modified Ashworth scale (MAS) between baseline and endpoint
Time Frame: 3 weeks
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.
3 weeks
Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint
Time Frame: 3 weeks
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.
3 weeks
Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint
Time Frame: 3 weeks
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.
3 weeks
mean difference of the occurrence numbers of adverse events
Time Frame: 3 times per week, 3 weeks, through study completion,
At every visit, assessors will ask a post-interventional question about adverse events. The number of adverse events will be recorded for each group.
3 times per week, 3 weeks, through study completion,

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
new Blinding index (BI)
Time Frame: 3 weeks (only at the end of the study)
Patients and outcome assesses will be asked which group they think they belong to and select one of the answers (verum electroacupuncture group, sham electroacupuncture group, or unknown). With the answers, the new BI will be calculated with mean and variances following the preceding study. The index score varies from 1 of complete lack of blinding, 0 of consistency with perfect blinding, or -1 of opposite guessing of their groups.
3 weeks (only at the end of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University

Collaborators

National Rehabilitation Center, Seoul, Korea
Wonkwang University Gwangju Medical Center

Investigators

  • Principal Investigator: Euiji Lee, Ph.D., Kyunghee University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Actual)

November 29, 2017

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

February 26, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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