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

University Hospital Center (CHU) Dijon Bourgogne

Status: Enrolling

Conditions: Endometriosis; Pain

Treatments: Other: Placebo session; Other: Korean manupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06073379

POUHIN AOIparaM 2021

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Korean manupuncture

Experimental group

Treatment:

Other: Korean manupuncture

Placebo/control

Placebo Comparator group

Treatment:

Other: Placebo session