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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06073379

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Pain	Other: Korean manupuncture Other: Placebo session	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Korean manupuncture	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 Comparator: Placebo/control	Other: 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)

Arm

Intervention/Treatment

Experimental: Korean manupuncture

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 Comparator: Placebo/control

Other: 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)

Outcome Measures

Primary Outcome Measures

Variation in the Visual Analog Scale (VAS) [Between Day 1 and Day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Person having given oral consent
Woman aged 18 years or older
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourgogne	Dijon		France

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT06073379

Other Study ID Numbers:

POUHIN AOIparaM 2021

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Oct 10, 2023