Pelvic Pain Electro-Acupuncture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSt. Olavs Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Use of opioid pain relief

Concurrent participation in other pain management trials

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Intervention, electroacupunctureExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

NRS

Changes in pain intensity measured via validated pain scale NRS

Time frame
Baseline, after three months, and the day of surgery, average 6 months after baseline
2

Quality of life SF-36

standardized questionnaire measuring quality of life (SF-36)

Time frame
Baseline, after three months, and the day of surgery, average 6 months after baseline
3

Change in pain medication use

Change in pain medication use

Time frame
Baseline, after three months, and the day of surgery, average 6 months after baseline
4

Amsterdam complex pelvic pain scale

Changes in Amsterdam complex pelvic pain scale

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

Secondary outcomes

1

FSFI

Changes in sexual function FSFI

Time frame
Baseline, after three months, and the day of surgery, average 6 months after baseline
2

FSDS-r

Changes in sexual function (FSDS-r)

Time frame
Baseline, after three months, and the day of surgery, average 6 months after baseline
3

levator hiatal dimensions

Chenges in levator hiatal area and anteroposterior diameter measured at rest and contraction

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

Other outcomes

Sponsors and contacts

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