Stroke Clinical Trial
— EAPSSPOfficial 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
Verified date | November 2017 |
Source | Kyunghee University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 29, 2017 |
Est. primary completion date | November 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Korean Medicine Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyunghee University | National Rehabilitation Center, Seoul, Korea, Wonkwang University Gwangju Medical Center |
Korea, Republic of,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | new Blinding index (BI) | 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) | |
Primary | 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 | 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. | 1~3 weeks | |
Secondary | 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). | 3 weeks | |
Secondary | 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°) | 3 weeks | |
Secondary | 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. | 3 weeks | |
Secondary | 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. | 3 weeks | |
Secondary | 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. | 3 weeks | |
Secondary | 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. | 3 weeks | |
Secondary | 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. | 3 weeks | |
Secondary | 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. | 3 times per week, 3 weeks, through study completion, |
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