Thread Embedding vs. Electroacupuncture for Post-Stroke Aphasia

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-07-31

Brief Summary

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The goal of this clinical trial was to learn if thread embedding or electroacupuncture can treat language function impairment in patients with post-stroke aphasia, a condition affecting communication after a stroke. The main questions it aimed to answer were:

Does thread embedding improve overall language function more effectively than electroacupuncture, as measured by the Goodglass and Kaplan Aphasia Severity Rating Scale (ASRS)? How do thread embedding and electroacupuncture compare in improving specific language skills, such as motor speech, sensory language, reading, and naming, as assessed by the Boston Diagnostic Aphasia Examination (BDAE)? Researchers compared thread embedding (TE group) to electroacupuncture (EA group) to see if thread embedding provides better or similar effects on language recovery.

Participants:

Underwent a 30-day intervention with language assessments at the start and end of the period.

Were randomly assigned to either the thread embedding group, receiving treatment every 10 days, or the electroacupuncture group, receiving daily 20-minute sessions.

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Detailed Description

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This study was designed as a randomized, open-label, parallel-group trial conducted at the Traditional Medicine Hospital in Dak Lak, Vietnam. It received ethical approval from the Biomedical Research Ethic Committee at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 739/HĐĐĐ-ĐHYD, dated December 14, 2021). The interventions were delivered by certified traditional medicine practitioners following strict protocols (STRICTA 2010).

Catgut Thread Embedding (TE group): Participants received thread embedding at the EX-HN21 acupoint.

Electroacupuncture (EA group): Participants underwent daily 20-minute sessions in 30 days.

Language function was assessed using standardized tools, and data were analyzed with R. Statistical tests (chi-square, t-tests) compared baseline characteristics and outcomes, with a significance level of p \< 0.05.

Conditions

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Post-stroke Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cagut Thread Embedding Group

Patients received catgut thread embedding at day 0, day 10 and day 20.

Group Type EXPERIMENTAL

Catgut Thread Embedding

Intervention Type PROCEDURE

Catgut Thread Embedding involved implanting chromic catgut size 4.0 thread, which is attached to a 23G guide needle, into subcutaneous tissue at EX-HN21 acupoint. The guide needle was removed after insertion, while the thread remained and dissolved over 10-15 days to provide continuous stimulation.

Electroacupuncture Group

Patients received daily electroacupuncture for 20 minutes over 30 days.

Group Type ACTIVE_COMPARATOR

Electroacupuncture

Intervention Type PROCEDURE

Electroacupuncture was administered using four needles (0.3 × 25 mm, diameter × length) inserted at GV-20, EX-HN21, external EX-HN12, and external EX-HN13 acupoints. Electrical stimulation was delivered via the KWD-808I Multipurpose Health Device (Changzhou Yingdi Electronic Medical Device Co., China) with parameters set at 3 Hz frequency and 0.6 ms pulse width, the intensity was adjusted according to the patient's perception. Electroacupuncture was performed daily, except on Saturdays, Sundays, and Vietnamese national holidays, over a treatment course of 30 days.

Interventions

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Catgut Thread Embedding

Catgut Thread Embedding involved implanting chromic catgut size 4.0 thread, which is attached to a 23G guide needle, into subcutaneous tissue at EX-HN21 acupoint. The guide needle was removed after insertion, while the thread remained and dissolved over 10-15 days to provide continuous stimulation.

Intervention Type PROCEDURE

Electroacupuncture

Electroacupuncture was administered using four needles (0.3 × 25 mm, diameter × length) inserted at GV-20, EX-HN21, external EX-HN12, and external EX-HN13 acupoints. Electrical stimulation was delivered via the KWD-808I Multipurpose Health Device (Changzhou Yingdi Electronic Medical Device Co., China) with parameters set at 3 Hz frequency and 0.6 ms pulse width, the intensity was adjusted according to the patient's perception. Electroacupuncture was performed daily, except on Saturdays, Sundays, and Vietnamese national holidays, over a treatment course of 30 days.

Intervention Type PROCEDURE

Other Intervention Names

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Thread Embedding Catgut Embedding Electrical Acupuncture Electrical Stimulation Acupuncture

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with post-stroke aphasia (severity levels 0-4 on the Goodglass and Kaplan scale)
* Aged 18 years or older
* Fluent in Vietnamese
* Alert and mentally competent (no psychiatric or neurological disorders affecting communication)
* No pre-existing speech or language disorders
* Willing to participate and provide signed informed consent
* Treated as inpatients at the Traditional Medicine Hospital, Dak Lak

Exclusion Criteria

* Severe physical exhaustion or skin ulcers/infections at intervention sites
* Presence of a pacemaker
* Allergy to catgut threads
* Post-stroke patients awaiting cranioplasty
* Complex disease progression requiring alternative treatments during the study (data analyzed as treatment failures)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No