Including healthy young individuals, individuals with complete paraplegia, and those with diabetic foot
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Volunteers Inclusion Criteria: Aged 18–30 years; In good general health as confirmed by routine physical examination; No acupuncture or physical therapy received within the past month; Able and willing to provide written informed consent. 2. Patients with Complete Paraplegia Inclusion Criteria: Diagnosis of complete spinal cord injury (ASIA Impairment Scale Grade A, injury level below T6); Aged 18–60 years; Disease duration = 6 months and neurologically stable; Free from severe pressure ulcers or acute complications; Capable of understanding and providing written informed consent. 3. Patients with Diabetic Foot Inclusion Criteria: Diagnosis of diabetic foot (Wagner Grade 0); Presenting with symptoms such as coolness and numbness in the lower limbs; Aged 30–75 years; Disease duration = 1 year and clinically stable; Palpable dorsalis pedis artery pulse; Able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Healthy Volunteers Exclusion Criteria: Severe cardiovascular disease, coagulation disorders, or skin infections; History of allergic diseases, such as eczema and rhinitis; Recent symptoms of autonomic dysfunction such as palpitations and night sweats; History of fainting during acupuncture; Known allergy to electrode coupling gel; Pregnancy or lactation. 2. Patients with Complete Paraplegia Exclusion Criteria: Severe cardiac, hepatic, or renal dysfunction; Acute systemic infections or active autoimmune diseases; Recent use of vasodilators or medications that affect autonomic nerve function; Skin breakdown or infection at the proposed stimulation sites; Significant psychiatric disorders or cognitive impairments that preclude the ability to provide informed consent. 3. Patients with Diabetic Foot Exclusion Criteria: Severe cardiac, hepatic, or renal dysfunction; Extensive foot gangrene or acute severe infection; Recent use of vasodilators or medications affecting autonomic nerve function; Local skin ulceration or infection at the proposed acupuncture points; Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCT 1: 128-channel surface electromyography (EMG) and electroencephalography (EEG) signals;RCT 2: Standard Deviation of Diastolic Blood Pressure (DBP_STD);RCT 2: Heart Rate Variability (HRV);RCT 2: Laser Speckle Microcirculation Parameters;RCT 3: Standard Deviation of Diastolic Blood Pressure (DBP_STD);RCT 4: Standard Deviation of Diastolic Blood Pressure (DBP_STD);RCT 4: Heart Rate Variability (HRV);RCT 5: Laser Speckle Blood Perfusion;Observational Trail 1: Acupuncture Sensation Scale;Observational Trail 2: Acupuncture Sensation;Observational Trail 2: Massachusetts General Hospital Acupuncture Sensation Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| RCT 1: Signal Changes at Baseline, During Needling, and Immediately, 30, and 120 Minutes Post-Needling;RCT2: surface electromyography;RCT 2: Respiratory Rate;RCT 2: Oxygen Saturation;RCT 2: Multiple Signal Coupling Analysis;RCT 3: Heart Rate Variability (HRV);RCT 3: Cardiac Output;RCT 3: surface electromyography;RCT 3: Respiratory Rate;RCT 3: Oxygen Saturation;RCT 3: Laser Speckle Microcirculation Parameters;RCT 4: Cardiac Output;RCT 4: surface electromyography;RCT 4: Respiratory Rate;RCT 4: Oxygen Saturation;RCT 4: Laser Speckle Microcirculation Parameters;RCT 5: Plantar Temperature Changes by Infrared Thermography;RCT 5: Diabetic Foot Assessment Scale;RCT 5: Neurogenic/Myogenic Power from Laser Speckle;Observational Trail 1: Skin Resistance;Observational Experiment 1: Ultrasound Image;Observational Trail 1: Laser Speckle Microcirculation Parameters;Observational Trail 2: Skin Resistance;Observational Trail 2: Laser Speckle Microcirculation Parameters;Observational Trail 2: Ultrasound Image; | — |
Countries
China
Contacts
The Sixth Medical Center of Chinese PLA General Hospital