Skip to content

A multicenter, prospective, randomized, double-blind, controlled study on percutaneous wrist-ankle nerve electrical stimulation for the relief of afterpains

A multicenter, prospective, randomized, double-blind, controlled study on percutaneous wrist-ankle nerve electrical stimulation for the relief of afterpains

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002539
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

afterpains

Interventions

Experimental Group (High-intensity Group):The current intensity is adjusted to the maximum level that the patient can tolerate (above the sensory threshold, with a strong tingling sensation but no pai
Control group (low-intensity group):The device will output a perceptible current within the first 30 seconds (to convince the patient that the treatment has begun), and then automatically reduce to be

Sponsors

The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Full-term pregnant women (=37 weeks) who delivered vaginally or by cesarean section; 2) Age: 18 to 45 years old; 3) Voluntarily participate in this experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Severe pregnancy complications (such as eclampsia, placental abruption); 2) History of implanted cardiac pacemaker or epilepsy; 3) Long-term use of analgesics or chronic pain history; 4) Depression scale, anxiety scale = 50 points (Self-Rating Anxiety Scale/Self-Rating Depression Scale score below 50 points is normal; 50-60 points is mild anxiety; 61-70 points is moderate anxiety; over 70 points is severe anxiety); 5) Other pain-related diseases; 6) Skin damage, dermatitis, infection or abnormal sensation in the area where the electrode patches are attached; 7) Known allergy to electrical stimulation or other contraindications for TENS treatment; 8) Cognitive impairment or mental illness, unable to cooperate with the research assessment; 9) Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The peak pain Visual Analogue Scale (VAS) within 72 hours.;

Secondary

MeasureTime frame
pain intensity;Number of occurrences and frequency of pain;Heart rate at each time point;Galvanic skin response;Short Form McGill Pain Questionnaire;PSQI Score;Rescue Analgesia Rate;First rescue analgesia time;Morphine-equivalent daily dose;Postpartum Recovery Status;Serum ß-endorphin, Substance P, Prostaglandin F2a;Heart Rate Variability;Uterine involution status;Adverse Event;

Countries

China

Contacts

Public ContactJin Yu

The First Affiliated Hospital of Naval Medical University

395005545@163.com021-31161959

Outcome results

None listed

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