Pelvic Pain Electro-Acupuncture

NCT07305025 | Not Yet Recruiting

• 1 other identifier: REK 910176
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to investigate if a series of up to 9 treatment sessions of electroacupuncture can be used to alleviate pain in women with suspected endometriosis, scheduled for diagnostic laparoscopy

Conditions

Pelvic Pain; Endometriosis

Keywords

pelvic pain; endometriosis; acupuncture; sexual function; quality of life; pelvic floor muscle function

Outcome Measures

Primary Outcomes (4)

• NRS

  Changes in pain intensity measured via validated pain scale NRS

  Baseline, after three months, and the day of surgery, average 6 months after baseline

• Quality of life SF-36

  standardized questionnaire measuring quality of life (SF-36)

  Baseline, after three months, and the day of surgery, average 6 months after baseline

• Change in pain medication use

  Change in pain medication use

  Baseline, after three months, and the day of surgery, average 6 months after baseline

• Amsterdam complex pelvic pain scale

  Changes in Amsterdam complex pelvic pain scale

  Baseline, after three months, and the day of surgery, average 6 months after baseline

Secondary Outcomes (3)

• FSFI

  Baseline, after three months, and the day of surgery, average 6 months after baseline

• FSDS-r

  Baseline, after three months, and the day of surgery, average 6 months after baseline

• levator hiatal dimensions

  Baseline and the day of surgery, average 6 months after baseline

Study Arms (2)

Intervention, electroacupuncture

EXPERIMENTAL

Frequency: 3 sessions per week for 3 weeks. Needle retention time: \~30 minutes per session. Electroacupuncture at a frequency of 2 Hz Electroacupuncture Stimulation Parameters Electroacupuncture will be administered at a frequency of 2 Hz, as this has been shown to stimulate the release of endogenous opioids, including endorphins and enkephalins. These neuropeptides contribute to pain modulation and inflammation reduction via activation of the body's natural analgesic pathways (7). Additionally, low-frequency stimulation at 2 Hz has been associated with parasympathetic nervous system activation, which may further enhance pain relief by reducing stress-related sympathetic activity and promoting a relaxed physiological state. This dual mechanism makes 2 Hz electroacupuncture a suitable intervention for chronic and inflammatory pain conditions. Electrode placement and treatment duration will be standardized across participants to ensure consistency in stimulation intensity, needle depth

Device: Electro acupuncture

Control

NO INTERVENTION

Waiting as usual prior to surgery

Interventions

Electro acupuncture DEVICE

Frequency: 3 sessions per week for 3 weeks. Needle retention time: \~30 minutes per session. Electroacupuncture at a frequency of 2 Hz Electroacupuncture Stimulation Parameters Electroacupuncture will be administered at a frequency of 2 Hz, as this has been shown to stimulate the release of endogenous opioids, including endorphins and enkephalins. These neuropeptides contribute to pain modulation and inflammation reduction via activation of the body's natural analgesic pathways (7). Additionally, low-frequency stimulation at 2 Hz has been associated with parasympathetic nervous system activation, which may further enhance pain relief by reducing stress-related sympathetic activity and promoting a relaxed physiological state. This dual mechanism makes 2 Hz electroacupuncture a suitable intervention for chronic and inflammatory pain conditions. Electrode placement and treatment duration will be standardized across participants to ensure consistency in stimulation intensity, needle depth

Intervention, electroacupuncture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years referred for diagnostic laparoscopy with suspicion of endometriosis
• Experiencing moderate to severe pelvic pain
• Willing to commit to the treatment schedule and follow-up
• Understanding Norwegian or English to be able to communicate and fill out questionnaires

You may not qualify if:

• Pregnancy
• Use of opioid pain relief
• Concurrent participation in other pain management trials

Sponsors & Collaborators

• St. Olavs Hospital: lead

Related Links

• Related Info

MeSH Terms

Conditions

Pelvic Pain; Endometriosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ingrid Volløyhaug, PhD

  St.Olavs Hopsital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Volløyhaug, PhD

CONTACT

+47 72573831; ingrid.volloyhaug@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share