Clinical trial NCT06208059: Electroacupuncture of Scalp Motor Area to Improve Post-Stroke Wrist Dyskinesia
Official title: Electroacupuncture of Scalp Motor Area to Improve Post-Stroke Wrist Dyskinesia and Its Effect on Muscle Function: a Single-Blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Movement Disorders
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the clinical efficacy of electroacupuncture and manual acupuncture in stimulating the scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related active muscles. The main question it aims to answer is: which method of stimulating the scalp motor area is more effective in the recovery of wrist motor function after stroke? Participants will be given routine Western medicine treatment and acupuncture treatment on the hemiplegic side. In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side. The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. The score of Chinese Stroke Scale (CSS), the score of the upper limb of the Barthel Index (BI), the active range of motion (AROM) of wrist joint, and the surface electromyography (sEMG) was used to measure the root mean square (RMS) of extensor carpi radialis longus, extensor digitorum, flexor carpi radialis and flexor carpi ulnaris on the hemiplegic side of the patients before and after the 3-week treatment period, respectively compare the clinical efficacy of the two groups.

Detailed description: Participants will be randomly divided into an electroacupuncture group and a manual acupuncture group according to a ratio of 1: 1. In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side and left in place for 30 minutes after obtaining qi. During needle retention, the needles will be intermittently twisted for 2min twice, with a frequency of about 200 r/min. The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. After obtaining qi, electroacupuncture stimulation will be applied using a continuous wave at a frequency of 2 Hz. The stimulation intensity will be adjusted based on the patient's tolerance, and each treatment will be lasted for 30 minutes. Participants patients in both groups will be treated once a day and rest for one day after six consecutive days of treatment, for a total of three weeks.

Eligibility criteria: Inclusion Criteria:

1. patients with upper limb movement disorders who meet the diagnostic criteria for stroke;
2. 40 years old ≤ age ≤ 75 years old, gender is not limited;
3. head MRI or CT scanning found responsible lesions;
4. first onset of the disease, disease duration of 2 weeks to 6 months, stable condition, stable vital signs, conscious without unconsciousness;
5. upper limb muscle strength on the affected side ≥ grade 3, wrist dorsiflexion muscle strength ≥ grade 2, wrist flexion muscle strength ≥ grade 2;
6. no serious cardiac, pulmonary, or renal impairment;
7. voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

1. a previous history of stroke or other brain disease;
2. with severe mental retardation and/or severe aphasia that interferes with communication;
3. with severe cardiac, pulmonary, and renal impairment in an unstable condition;
4. inability to autonomously perform wrist flexion and extension movements on the hemiplegic side;
5. neurological or musculoskeletal diseases affecting the recovery of limb function before the onset of the disease, with pre-existing abnormalities in bilateral wrist movements;
6. allergy to adhesive tape, solid gel, etc.; bleeding tendency, acute suppurative inflammation, combined ulcers, infections, scars and tumors at acupuncture points and nearby areas; installation of pacemakers;
7. transient ischemic attack, rebleeding after infarction, bilateral cerebral infarction, brain stem infarction, excessive cerebral hemorrhage or cranial defect;
8. history of needle fainting or fear of needling.

Primary outcomes:
measure: Chinese Stroke Scale
timeFrame: 1 day before treatment and at the end of 3 weeks of treatment
Secondary outcomes:
measure: the Barthel Index of ADL
timeFrame: 1 day before treatment and at the end of 3 weeks of treatment
measure: Active Range of Motion
timeFrame: 1 day before treatment and at the end of 3 weeks of treatment
measure: Root Mean Square
timeFrame: 1 day before treatment and at the end of 3 weeks of treatment
Other outcomes:
measure: Clinical efficacy evaluation
timeFrame: the end of 3 weeks of treatment
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
name: Dongyan Wang, PhD
role: STUDY_DIRECTOR
References: