Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial

Pain Clinical Trial

— ENVOL  

Official title:

Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073379
• Other study ID #: POUHIN AOIparaM 2021
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Céline POUHIN
• Phone: 03 80 29 58 41
• Email: celine.pouhin[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endometriosis is defined as the presence and development of hormone-dependent endometrial tissue comprising both glands and stroma outside the endometrium and myometrium. It affects 10-15% of women of childbearing age; of these, 25% are diagnosed following a consultation for infertility, and 25% following a consultation for pelvic pain. This disease has a strong functional (pain and infertility) and organic impact, its numerous symptoms can have a considerable effect on quality of life. Individualized analgesic management with multidisciplinary care (medical, surgical and psychological) can improve quality of life for women with endometriosis, but current treatment remains insufficient. Korean manupuncture is a complementary treatment technique that does not interact with current treatments. It's a holistic discipline that draws up a highly detailed map of the body's correspondence on the hand. Each body zone corresponds to a zone on the hand. The aim of this research is to evaluate the effect of Korean manupuncture on endometriosis-related pain. Patients will be randomly assigned to 2 groups, 30 to the "Korean manupuncture" group and 30 to the "placebo/control" group. Patients will be blinded to their assigned group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Person having given oral consent
• Woman of legal age
• Woman diagnosed with endometriosis consulting for pain management

Exclusion Criteria:

• Not affiliated to the national health insurance system
• Person under legal protection (curatorship, guardianship)
• Person under court order
• Pregnant or breast-feeding women
• Menopausal women (menopause is defined as amenorrhea lasting more than 12 consecutive months)
• An adult unable to give consent
• Women who have had a hysterectomy
• Women who cannot speak or read French
• Hands not accessible for treatment
• Inability to follow the entire protocol
• Cognitive impairment

Related Conditions & MeSH terms

• Endometriosis
• Pain

Intervention

Other:
• Korean manupuncture
Energy assessment on hands and body Correspondence point technique on hands Energy rebalancing with ki Maeks on hands Moxa technique on hands
• Placebo session
Energy assessment on hands and body Correspondence point technique on the hands Energy rebalancing with ki Maeks on hands (use of Qi bong) Moxa technique on hands (placebo moxas)

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in the Visual Analog Scale (VAS)		Between Day 1 and Day 29