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Low-frequency Electrical Stimulation of Acupuncture Points

Master's Degree Candidate in Acupuncture and Tuina

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06061731
Enrollment
57
Registered
2023-09-29
Start date
2022-01-01
Completion date
2022-12-12
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Sequelae

Brief summary

Abstract: Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.

Detailed description

Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment.

Interventions

DRUGlow-frequency acupoint electrical stimulation

In order to determine the efficacy of low-frequency acupoint electrical stimulation and electroacupuncture to improve thumb to finger action after stroke

Sponsors

Xue Xia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

low-frequency acupoint electrical stimulation

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

①Diagnostic criteria for upper extremity motor dysfunction after stroke. ②Age 35-75 years and duration of illness is 2 weeks to 3 months. ③ Impaired hand function with Lovett classification ≥ grade 2 and MAS ≤ grade 2. ④No organ dysfunction such as heart, liver, lung, kidney or blood circulation dysfunction. ⑤Clear consciousness, no major impairment in intelligence, hearing or speech, and stable condition. ⑥Patients voluntarily participated in this subject trial and signed the informed consent form.

Exclusion criteria

* Presence of neurological or musculoskeletal disorders affecting functional recovery prior to the onset of the disease. ②Brainstem infarction, bilateral cerebral infarction or transient ischemic attack.

Design outcomes

Primary

MeasureTime frameDescription
sEMG eigenvaluesThree weekssEMG eigenvalues: two main aspects, maximum value (MAX), and root mean square value (RMS). MAX reflects the maximum contraction strength of the measured muscle. RMS is the root mean square of the EMG transient amplitude over time, which reflects the average change in EMG signal and is therefore used as an evaluation of muscle contraction performance.

Secondary

MeasureTime frameDescription
CSS scoreThree weeksIn this study, the upper extremity and hand muscle strength and motor function were assessed to evaluate the efficacy of patients, and the consciousness, upper extremity and hand evaluation components were selected for assessment. The lower the CSS score, the better the improvement in neurological deficits.
Brunnstrom's method of motor function evaluationThree weeksGrade I: no movement; Grade II: only weak flexion and extension; Grade III: hook grasp, but not finger extension; Grade IV: able to pinch laterally and thumb release, fingers can be extended semi-randomly and to a small extent; Grade V: can ball and column grasp, fingers extend simultaneously, but not individually; Grade VI: all grasps can be completed, but the speed and accuracy are worse than the non-involved side.
Lindmark hand function scoreThree weeks1 point: gripping action can be completed, but can not resist tiny resistance; 2 points: can hold an object for 5s, but can not resist medium resistance, or grip is not standard, uncoordinated; 3 points: grip is normal, can hold an object against larger resistance for 5s, and can release the hand like normal people, the total score is 24 points, the higher the score, the The higher the score, the better the hand function.
Lovett muscle strength classificationThree weeksGrade 0: complete muscle paralysis, palpation muscle completely no contraction; Grade I: slight muscle contraction, but can not cause joint movement; Grade II: can drive the joint horizontal activity, but can not fight gravity; Grade III: can fight gravity to do active joint activity, but can not fight resistance; Grade IV: can fight a larger resistance, but weaker than normal; Grade V: normal muscle strength .
Modified Ashworth ScaleThree weeksno increase in muscle tone; Grade 1: mildly increased muscle tone, with minor resistance felt during passive flexion/extension to the maximum extent in grasping movements; Grade 1+: slightly increased muscle tone, with minor resistance felt during flexion/extension to more than 1/2 range in grasping movements; Grade 2: heavy resistance felt in most ranges of motion, but passive activities can be performed Grade 3: muscle tone is significantly elevated and passive activities are not easily performed; Grade 4: the affected portion of the limb exhibits tonic extension or flexion.

Other

MeasureTime frameDescription
Clinical efficacy evaluationThree weeksClinical efficacy was assessed using the nimodipine method as a percentage reduction in CSS score: \[(pre-treatment score - post-treatment score)/pre-treatment score\] × 100%. Basic healing: reduction rate ≥90%; Significant improvement: 46%≤ minus rate \<90%; Progress: 18%≤ minus rate \<46%; The ratio of the sum of basic healing, obvious progress, and progress to the sample size of a single group is the total effective rate of the group.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026