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Low-frequency Electrical Stimulation of Acupuncture Points

NCT ID: NCT06061731

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-12

Brief Summary

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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

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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.

Conditions

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Stroke Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

low-frequency acupoint electrical stimulation
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low frequency group treatment

Low frequency group treatment: The treatment frequency is selected as 50Hz, pulse width 0.3ms, waveform is intermittent waveform, stimulation intensity is tolerated by the patient, the instrument program is set to stimulate the first group of acupoints → second group → first group → third group, forming a set of programmed movements, cyclic operation, appearing alternate movements of flexor and extensor muscles, namely: wrist dorsal extension, five-finger extension → five-finger flexion → wrist dorsal extension, five-finger extension → thumb-index finger pair pinching, simulating fine movements Grasp of the hand, thumb-index finger pair pinch. The treatment course was the same as that of the electroacupuncture group.

Group Type ACTIVE_COMPARATOR

low-frequency acupoint electrical stimulation

Intervention Type DRUG

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

Electroacupuncture group treatment

Electroacupuncture group treatment: After the above acupuncture to deqi, choose KWD-808 Ⅰ type Indy brand pulse acupuncture treatment instrument, the waveform is continuous wave, the stimulation frequency is 2Hz, the intensity to be tolerated by the patient. There should be muscle contraction at the acupuncture site during electroacupuncture treatment. The treatment time should be 30 minutes each time, once a day, 6 days a week with 1 day off, for a total of 3 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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low-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

Intervention Type DRUG

Other Intervention Names

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electroacupuncture

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xue Xia

OTHER

Sponsor Role lead

Responsible Party

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Xue Xia

Graduate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xue Xia

Role: STUDY_CHAIR

Heilongjiang University of Chinese Medicine

Locations

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Low-Frequency Acupoint Electrical Stimulation

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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12230000414003578W

Identifier Type: -

Identifier Source: org_study_id