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Non-inferiority Randomized Controlled Trial Comparing Long Electroacupuncture Deep Needling at Xialiao (BL34) and Huiyang (BL35) with Electromyographic Biofeedback Therapy for Levator Ani Syndrome (LAS)

Non-inferiority Randomized Controlled Trial Comparing Long Electroacupuncture Deep Needling at Xialiao (BL34) and Huiyang (BL35) with Electromyographic Biofeedback Therapy for Levator Ani Syndrome (LAS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000207
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Levator Ani Syndrome

Interventions

Electroacupuncture Group:Bilateral Xialiao (BL34) and Huiyang (BL35) long electroacupuncture deep needling, 3 sessions/week for 8 weeks (24 sessions), 30 minutes/session with 2Hz low-frequency stimula
Biofeedback:Weisi EMG biofeedback system training, 3 sessions/week for 8 weeks (24 sessions), 30 minutes/session pelvic floor relaxation and coordination training

Sponsors

Suzhou Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged 18-75 years; Meet Rome IV LAS criteria with positive digital rectal exam for puborectalis/levator ani tenderness; Baseline "7-day average pain NRS (0-10) =4"; Allow comorbid constipation/defecation disorders (recorded for subgroup analysis); Able to complete study and provide informed consent.

Exclusion criteria

Exclusion criteria: Organic anorectal diseases explaining symptoms (e.g., tumors, active inflammation, acute abscess/infection); Major anorectal surgery or acute perianal infection within 3 months; Severe cardiopulmonary diseases, bleeding tendencies, pacemakers/implantable defibrillators; Pregnancy/lactation; Severe mental/cognitive impairment affecting compliance; Other conditions deemed unsuitable by investigators.

Design outcomes

Primary

MeasureTime frame
numerical rating scale;

Secondary

MeasureTime frame
Tenderness Score;Patient Global Impression of Change and Adequate Relief;Short Form-36;Patient Assessment of Constipation Symptoms;Anorectal Manometry and Balloon Expulsion Test;Safety Index;

Countries

China

Contacts

Public ContactWu Bensheng

Suzhou Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine

fsyy00531@njucm.edu.cn0512-67872186

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026