Low-frequency Electrical Stimulation of Acupuncture Points

NCT06061731 | Completed Early Phase 1

• 1 other identifier: 12230000414003578W
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (1)

• sEMG eigenvalues

  sEMG 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.

  Three weeks

Secondary Outcomes (5)

• CSS score

  Three weeks

• Brunnstrom's method of motor function evaluation

  Three weeks

• Modified Ashworth Scale

  Three weeks

• Lindmark hand function score

  Three weeks

• Lovett muscle strength classification

  Three weeks

Other Outcomes (1)

• Clinical efficacy evaluation

  Three weeks

Study Arms (2)

Low frequency group treatment

ACTIVE COMPARATOR

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.

Drug: low-frequency acupoint electrical stimulation

Electroacupuncture group treatment

NO INTERVENTION

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.

Interventions

low-frequency acupoint electrical stimulation DRUG

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

Also known as: electroacupuncture

Low frequency group treatment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xue Xia: lead

Study Sites (1)

Low-Frequency Acupoint Electrical Stimulation

Harbin, Heilongjiang, 150040, China

Location

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Xue Xia

  Heilongjiang University of Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate

Model Details: low-frequency acupoint electrical stimulation

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)