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

Primary Purpose

Endometriosis, Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Korean manupuncture
Placebo session
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Korean manupuncture

Placebo/control

Arm Description

Outcomes

Primary Outcome Measures

Variation in the Visual Analog Scale (VAS)

Secondary Outcome Measures

Full Information

First Posted
September 29, 2023
Last Updated
October 5, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT06073379
Brief Title
Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial
Acronym
ENVOL
Official Title
Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Korean manupuncture
Arm Type
Experimental
Arm Title
Placebo/control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Korean manupuncture
Intervention Description
Energy assessment on hands and body Correspondence point technique on hands Energy rebalancing with ki Maeks on hands Moxa technique on hands
Intervention Type
Other
Intervention Name(s)
Placebo session
Intervention Description
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)
Primary Outcome Measure Information:
Title
Variation in the Visual Analog Scale (VAS)
Time Frame
Between Day 1 and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline POUHIN
Phone
03 80 29 58 41
Email
celine.pouhin@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline POUHIN
Phone
03 80 29 58 41
Email
celine.pouhin@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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