NCT06460376

Brief Summary

This project was a Randomized controlled trial conducted to check the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. The duration was 6 months, convenient sampling was done, subjects following eligibility criteria from DHQ Hospital Narowal and THQ Hospital Shakargarh were randomly assigned, a baseline assessment was done, Group A participants were given baseline treatment along with wurn technique 2 sessions per week for 6 weeks, Group B participants were given baseline treatment along with mercier therapy 1 session per week for 6 weeks, the post-intervention assessment was done, via the Marinoff Scale, Mankoski Pain Scale and Endometriosis Health Profile Questionnaire (EHP 30). Data was analyzed by using SPSS version 26. Detailed Description: Endometriosis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 11, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

DyspareuniaDysmenorrheaendometriosis

Outcome Measures

Primary Outcomes (1)

  • Endometriosis Health Profile Questionnaire (EHP 30)

    Endometriosis health profile questionnaire (EHP 30) is to evaluate the suitably self- report health status. It involves 30 items to identify the health status of patients with endometriosis.A core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being support and self-image). Internal consistency reliability is high for all dimensions (alpha ranged from 0.84 to 0.91)

    6 Weeks

Secondary Outcomes (1)

  • Mankoski Pain Scale

    6 weeks

Other Outcomes (1)

  • Marinoff Scale

    6 weeks

Study Arms (2)

Wurn technique

EXPERIMENTAL

The principle intent of the Wurn Technique is to decrease pain and increase mobility and function of abdominopelvic and reproductive organs by diminishing adhesions. The protocol focuses on deforming the adhesive collagen cross-links comprising adhesions that appear to contribute to the underlying causes of endometriosis.

Other: Wurn Technique

Mercier therapy

ACTIVE COMPARATOR

The principal intent of mercier therapy is visceral pelvic manipulation that addresses scar tissue, adhesions, and the misalignment of pelvic organs. It increases blood flow and circulation to the pelvis.

Other: Mercier Therapy

Interventions

Treatment: Site-specific pressures for 30 seconds across the restrictive bands of adhered tissues and structures, working progressively deeper from the most superficial tissues Traction: focusing on these adhered areas, engage the uterine fundus and sidewalls and traction them to the left. To assist and improve the mobility of the soft tissues, release the traction tension either suddenly or gradually, depending on the desired effect to decrease spasms and adhesions between the uterus and the bladder. The baseline treatment was moist heat. Each therapy session was 30 minutes for 6 weeks and 2 sessions per week. 10 minutes for baseline treatment.

Wurn technique

Treatment: The patient lay face up on a massage or exam table. Feel viscera, major internal organs located in the abdomen by lightly pressing through abdominal muscles. Manual poking, pressing, and massage actions do three things: Reveals visceral adhesions. Find tender spots. Breaks up adhesions. Massaging and pressing stretch the collagen fibers that make up fascia, which loosens tightly bound fibers to break up adhesions. This releases the organs and allows them to move more freely. Abdominal massage with pressing, deep strokes, and friction. The baseline treatment was moist heat. Each therapy session was 25 minutes for 6 weeks and 1 session per week. 10 minutes for baseline treatment

Mercier therapy

Eligibility Criteria

Age25 Years - 43 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranging from 25-43(17)
  • Diagnosed patients with endometriosis
  • BMI (18.5-29.9),(normal and overweight)
  • Multigravida
  • Mode of delivery: vaginal delivery or c section both
  • Females having grade 1 or 2 grade on the dyspareunia scale
  • Females having moderate scores on EHP -30

You may not qualify if:

  • Malignancy
  • Pregnancy
  • Fibroids
  • Pelvic congestion syndrome
  • Pelvic inflammatory disease
  • Females having IUD (inter uterine device)
  • Recent abdominal or pelvic surgery
  • Ovarian abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DHQ Hospital Narowal

Narowal, Punjab Province, Pakistan

Location

THQ Hospital Shakargarh

Shakargarh, Punjab Province, Pakistan

Location

Related Publications (8)

  • Koninckx PR, Fernandes R, Ussia A, Schindler L, Wattiez A, Al-Suwaidi S, Amro B, Al-Maamari B, Hakim Z, Tahlak M. Pathogenesis Based Diagnosis and Treatment of Endometriosis. Front Endocrinol (Lausanne). 2021 Nov 25;12:745548. doi: 10.3389/fendo.2021.745548. eCollection 2021.

    PMID: 34899597BACKGROUND
  • Lee SY, Koo YJ, Lee DH. Classification of endometriosis. Yeungnam Univ J Med. 2021 Jan;38(1):10-18. doi: 10.12701/yujm.2020.00444. Epub 2020 Aug 7.

    PMID: 32764213BACKGROUND
  • International Working Group of AAGL, ESGE, ESHRE and WES; Tomassetti C, Johnson NP, Petrozza J, Abrao MS, Einarsson JI, Horne AW, Lee TTM, Missmer S, Vermeulen N, Zondervan KT, Grimbizis G, De Wilde RL. An international terminology for endometriosis, 2021. Hum Reprod Open. 2021 Oct 22;2021(4):hoab029. doi: 10.1093/hropen/hoab029. eCollection 2021.

    PMID: 34693033BACKGROUND
  • Vallve-Juanico J, Houshdaran S, Giudice LC. The endometrial immune environment of women with endometriosis. Hum Reprod Update. 2019 Sep 11;25(5):564-591. doi: 10.1093/humupd/dmz018.

    PMID: 31424502BACKGROUND
  • Smolarz B, Szyllo K, Romanowicz H. Endometriosis: Epidemiology, Classification, Pathogenesis, Treatment and Genetics (Review of Literature). Int J Mol Sci. 2021 Sep 29;22(19):10554. doi: 10.3390/ijms221910554.

    PMID: 34638893BACKGROUND
  • Kapoor R, Stratopoulou CA, Dolmans MM. Pathogenesis of Endometriosis: New Insights into Prospective Therapies. Int J Mol Sci. 2021 Oct 28;22(21):11700. doi: 10.3390/ijms222111700.

    PMID: 34769130BACKGROUND
  • Arafah M, Rashid S, Akhtar M. Endometriosis: A Comprehensive Review. Adv Anat Pathol. 2021 Jan;28(1):30-43. doi: 10.1097/PAP.0000000000000288.

    PMID: 33044230BACKGROUND
  • Christ JP, Yu O, Schulze-Rath R, Grafton J, Hansen K, Reed SD. Incidence, prevalence, and trends in endometriosis diagnosis: a United States population-based study from 2006 to 2015. Am J Obstet Gynecol. 2021 Nov;225(5):500.e1-500.e9. doi: 10.1016/j.ajog.2021.06.067. Epub 2021 Jun 17.

    PMID: 34147493BACKGROUND

MeSH Terms

Conditions

EndometriosisDyspareuniaDysmenorrhea

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hafiza Neelam

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations