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Electroacupuncture for Poststroke Patients With Shoulder Pain (EAPSSP)

Primary Purpose

Stroke, Shoulder Pain, Stroke, Complication

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
electroacupuncture
sham electroacupuncture
Sponsored by
Kyunghee University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring electroacupuncture, randomized controlled trial

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kyung Hee University Korean Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

verum electroacupuncture

sham electroacupuncture

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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°)
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 26, 2017
Last Updated
November 30, 2017
Sponsor
Kyunghee University
Collaborators
Wonkwang University Gwangju Medical Center, National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03086863
Brief Title
Electroacupuncture for Poststroke Patients With Shoulder Pain
Acronym
EAPSSP
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University
Collaborators
Wonkwang University Gwangju Medical Center, National Rehabilitation Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Shoulder Pain, Stroke, Complication, Cerebral Infarction, Cerebral Hemorrhage
Keywords
electroacupuncture, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verum electroacupuncture
Arm Type
Experimental
Arm 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.
Arm Title
sham electroacupuncture
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Other Intervention Name(s)
verum EA
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
sham electroacupuncture
Other Intervention Name(s)
sham EA
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mean difference of visual analogue scale (VAS) between baseline and endpoint
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
before-after change of visual analogue scale (VAS) (intragroup effect)
Description
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.
Time Frame
1~3 weeks
Title
Mean difference of pain rating scale (PRS) between baseline and endpoint
Description
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).
Time Frame
3 weeks
Title
Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint
Description
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°)
Time Frame
3 weeks
Title
Mean difference of passive ranges of motion (PROM) between baseline and endpoint
Description
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.
Time Frame
3 weeks
Title
Mean difference of manual muscle test (MMT) between baseline and endpoint
Description
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.
Time Frame
3 weeks
Title
Mean difference of modified Ashworth scale (MAS) between baseline and endpoint
Description
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.
Time Frame
3 weeks
Title
Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint
Description
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.
Time Frame
3 weeks
Title
Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint
Description
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.
Time Frame
3 weeks
Title
mean difference of the occurrence numbers of adverse events
Description
At every visit, assessors will ask a post-interventional question about adverse events. The number of adverse events will be recorded for each group.
Time Frame
3 times per week, 3 weeks, through study completion,
Other Pre-specified Outcome Measures:
Title
new Blinding index (BI)
Description
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.
Time Frame
3 weeks (only at the end of the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Euiji Lee, Ph.D.
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Korean Medicine Hospital
City
Seoul
ZIP/Postal Code
156-853
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27547224
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.
Results Reference
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PubMed Identifier
15020033
Citation
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.
Results Reference
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PubMed Identifier
12512790
Citation
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.
Results Reference
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PubMed Identifier
6226917
Citation
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.
Results Reference
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Citation
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)
Results Reference
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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.
Results Reference
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PubMed Identifier
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Citation
Mendell JR, Florence J. Manual muscle testing. Muscle Nerve. 1990;13 Suppl:S16-20. doi: 10.1002/mus.880131307. No abstract available.
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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.
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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)
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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)
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Results Reference
derived

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Electroacupuncture for Poststroke Patients With Shoulder Pain

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