- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460376
Comparative Effects of Wurn Technique and Mercier Therapy in Women With Endometriosis
Comparative Effects of Wurn Technique and Mercier Therapy on Dyspareunia, Dysmenorrhea, and Quality of Life in Women With Endometriosis
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, Phd
- Phone Number: 051-5481826
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Narowal, Punjab, Pakistan
- DHQ Hospital Narowal
-
Contact:
- Hafiza Neelam, MS
- Phone Number: 03204097476
- Email: hafiza.neelam@riphah.edu.pk
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Principal Investigator:
- Rimsha Azhar, MS-WH
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Shakargarh, Punjab, Pakistan
- THQ Hospital Shakargarh
-
Contact:
- Hafiza Neelam, MS
- Phone Number: 03204097476
- Email: hafiza.neelam@riphah.edu.pk
-
Principal Investigator:
- Rimsha Azhar, MS-WH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Malignancy
- Pregnancy
- Fibroids
- Pelvic congestion syndrome
- Pelvic inflammatory disease
- Females having IUD (inter uterine device)
- Recent abdominal or pelvic surgery
- Ovarian abscess
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wurn technique
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.
|
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. |
|
Active Comparator: Mercier therapy
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endometriosis Health Profile Questionnaire (EHP 30)
Time Frame: 6 Weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mankoski Pain Scale
Time Frame: 6 weeks
|
The Mankoski Pain Scale is a numerical scale ranging from zero to 10: zero indicates no pain and 10 represents pain so severe that an individual loses consciousness.
It will be used to indicate dysmenorrhea.The reliability of mankoski scale is 0.84
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marinoff Scale
Time Frame: 6 weeks
|
Marinoff scale is used to evaluate dyspareunia.
It includes 4 choices with a score of 0-3.
Reliability of the scale was obtained with a Cronbach's alpha of 0.94
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Neelam, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Arafah M, Rashid S, Akhtar M. Endometriosis: A Comprehensive Review. Adv Anat Pathol. 2021 Jan;28(1):30-43. doi: 10.1097/PAP.0000000000000288.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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