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Clinical Efficacy and Brain Functional Mechanisms of Jin's Three-Needle Therapy for Post-Stroke Fatigue: A Randomized Controlled Trial

Clinical Efficacy and Brain Functional Mechanisms of Jin's Three-Needle Therapy for Post-Stroke Fatigue: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001274
Enrollment
Unknown
Registered
2026-05-18
Start date
2026-05-18
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Post-Stroke Fatigue

Interventions

Acupuncture Group : Jin's Three-Needle Therapy
Sham Acupuncture Group:Sham Acupuncture

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Diagnostic Criteria for Post-Stroke Fatigue (PSF) Stroke patients who meet the following criteria: (1) Persistent fatigue occurring daily or almost daily for at least 2 weeks within the recent month, characterized by exhaustion or significant fatigue with decreased energy as the predominant features, requiring increased rest time, and disproportionate to physical or mental exertion; (2) Presence of the above symptoms plus any 3 of the following: 1) Fatigue not effectively relieved or restored by sleep or rest; 2) Motivation for rehabilitation exercises remains but efficiency declines; 3) Motor weakness requires continuous self-cognitive effort to overcome; 4) Difficulty initiating or maintaining daily activities due to subjective fatigue; 5) Post-exertional discomfort lasting several hours or longer; 6) Obvious preoccupation with fatigue sensations. Inclusion Criteria 1) Patients meeting the above diagnostic criteria for PSF; 2) Stroke onset =2 weeks and =1 year; 3) Male or female patients, first-ever stroke, aged 18–75 years; 4) Modified Rankin Scale (mRS) score =4, and Fatigue Severity Scale (FSS-7) mean score =4; 5) Good general condition, able to cooperate with fMRI and complete corresponding rehabilitation training; 6) Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: 1)Individuals not meeting the above inclusion criteria; 2)Severe cognitive impairment or other psychiatric disorders preventing cooperation; 3)Pre-stroke fatigue symptoms or concomitant diseases prone to cause fatigue, such as Parkinson's disease, multiple sclerosis, etc.; 4)Contraindications to acupuncture, including ulcers, abscesses, or skin infections at the needling sites; 5)Severe primary diseases of the circulatory, respiratory, digestive, urinary, endocrine, or hematopoietic systems; 6)Uncorrectable disseminated intravascular coagulation or severe thrombocytopenia with bleeding tendency (i.e., platelet count 1.5, hemoglobin <=90 g/L, or leukocyte count <=4*10^9/L); 7)Claustrophobia or contraindications to fMRI.

Design outcomes

Primary

MeasureTime frame
Fatigue Severity Scale (FSS-7);

Secondary

MeasureTime frame
Multidimensional Fatigue Scale (MFI-20);modified Rankin Scale (mRS);Energy Domain of the Stroke-Specific Quality of Life Scale (SS-QOL);Patient Health Questionnaire-9 (PHQ-9);Functional Independence Measure (FIM);Resting-state functional magnetic resonance imaging (rs-fMRI);

Countries

China

Contacts

Public ContactWang Bihan

Shenzhen Hospital of Southern Medical University

313253288@qq.com18818682441

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026