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A Randomized Controlled Trial on the Application of "Regulating Wei and Promoting Qi" Using Shallow Needle with Trembling Technique for Post-Stroke Sensory Disorders

A Randomized Controlled Trial on the Application of "Regulating Wei and Promoting Qi" Using Shallow Needle with Trembling Technique for Post-Stroke Sensory Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001897
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Sensory impairment after stroke

Interventions

Thalamic Sensory Impairment Group:Tremulous Shallow Needling
Healthy Volunteer Control Group:No intervention
Non-Thalamic Sensory Impairment:Tremulous Shallow Needling

Sponsors

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Inclusion Criteria for the Sensory Impairment Group: 1) Meet the diagnostic criteria for cerebral infarction as outlined in the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 and the diagnostic criteria for cerebral hemorrhage as per the Chinese Guidelines for Diagnosis and Treatment of Cerebral Hemorrhage 2019, with confirmation by cranial MRI or CT; 2) Aged 40–80 years, experiencing a first-ever stroke, or with a history of stroke but no significant sequelae or sensory impairment; 3) Presence of hemisensory impairment, with a superficial sensation score of <20 on the FLA (Functional Limb Assessment) and a VAS (Visual Analog Scale) score of =5 on the affected side; 4) Disease duration of 14 days to 3 months, falling within the recovery phase post-stroke; 5) Clear consciousness, cooperative during examination, stable vital signs, and good communication skills. (2) Inclusion Criteria for the Healthy Control Group: 1) Age (40–80 years) and gender matched with the patient group; 2) No history of stroke; 3) No history of sensory impairment; 4) Absence of conditions that may affect sensory function, such as severe diabetes, peripheral neuropathy, severe cardiovascular, hepatic, pulmonary, or renal diseases, malignant tumors, or psychiatric disorders; 5) Clear consciousness, cooperative during examination, stable vital signs, and good communication skills; 6) Voluntary participation and provision of signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Exclusion Criteria for the Sensory Impairment Group: 1) Sensory impairment caused by brain tumors or traumatic brain injury, as confirmed by imaging or related examinations; 2) Presence of peripheral neuropathy due to severe diabetes or other peripheral nerve disorders; 3) Comorbidities with other severe diseases, such as heart, liver, lung, or kidney failure, malignant tumors, etc.; 4) Accompanying motor, cognitive, or speech impairments, psychiatric disorders, or other conditions that may affect cooperation with treatment; 5) Pregnant or lactating women; 6) Contraindications to acupuncture therapy, such as local skin infection at the acupuncture site, acute infectious diseases, or coagulation disorders; 7) History of severe adverse reactions to acupuncture, such as acupuncture syncope (fainting during acupuncture). (2) Exclusion Criteria for the Healthy Control Group: 1) Any sensory dysfunction caused by diseases (e.g., severe diabetes, peripheral neuropathy) as confirmed by standard sensory examinations; 2) Comorbidities with other severe diseases, such as heart, liver, lung, or kidney failure, malignant tumors, etc.; 3) Accompanying motor, cognitive, or speech impairments, psychiatric disorders, or other conditions that may affect cooperation with treatment; 4) Pregnant or lactating women; 5) Contraindications to acupuncture therapy, such as local skin infection at the acupuncture site, acute infectious diseases, or coagulation disorders; 6) History of severe adverse reactions to acupuncture, such as acupuncture syncope (fainting during acupuncture).

Design outcomes

Primary

MeasureTime frame
Visual Analogue Pain Scale;Functional magnetic resonance imaging;Synchronized transcranial electrical stimulation and electroencephalogram;

Secondary

MeasureTime frame
Standardized Sensory Impairment Rating Scale; MASS Needle Sensation Assessment Scale;Electromyography (EMG) and Evoked Potential Testing;Semmes-Weinstein Monofilament Test;Vibration Testing;

Countries

China

Contacts

Public ContactBangqi Wu

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

wbqwbq587@outlook.com13622026323

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026