EndometriosisNCT06460376
Comparative Effects of Wurn Technique and Mercier Therapy in Women With Endometriosis
A study testing Wurn Technique and Mercier Therapy in people with Endometriosis, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 43 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Wurn Technique and Mercier Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesPakistan
- Study dates
- Jun 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Malignancy
- Pregnancy
- Fibroids
- Pelvic congestion syndrome
- Pelvic inflammatory disease
- Females having IUD (inter uterine device)
- Recent abdominal or pelvic surgery
- Ovarian abscess
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
DHQ Hospital Narowal
Narowal, Punjab Province
Hafiza Neelam, MS, 03204097476, hafiza.neelam@riphah.edu.pk
Rimsha Azhar, MS-WH
THQ Hospital Shakargarh
Shakargarh, Punjab Province
Hafiza Neelam, MS, 03204097476, hafiza.neelam@riphah.edu.pk
Rimsha Azhar, MS-WH
About this study
Official title: 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
Read the detailed description
Endometriosis is the condition involving the presence of glands or stroma of the endometrial lining outside the uterus cavity. Its characteristics include unpleasant pain in the pelvic region, impaired fertility, pain during or after sex, and heavy bleeding during periods. Endometriosis occurs as a result of genetic, angiogenic, immunological, and inflammatory factors. In endometriosis, adhesions may be formed due to local inflammation. It can also occur as the blood-filled implants start bleeding in their surroundings. As a result of this bleeding healing occurs which causes scar formation. Pharmacologically, NSAIDS are used for instant pain relief. The most common surgical approach is laparoscopy. Physiotherapy in its various forms can be an excellent complement to the gynecological treatment of endometriosis. as previous studies also reported the effect of pelvic massage, pelvic manipulation, kinesiotherapy, and hydrotherapy. According to researcher knowledge, there is limited evidence on wurn technique and mercier therapy and how these techniques improve dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. This study aims to see the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis.
- Conditions
- Endometriosis
- Being tested
- Wurn Technique, Mercier Therapy
- Keywords
- Dyspareunia, Dysmenorrhea, endometriosis
- Medical subject headings
- Endometriosis, Dyspareunia, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wurn TechniqueOther
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.
Mercier TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mercier Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 Weeks
Secondary outcomes (1)
Mankoski Pain Scale
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460376
- Sponsor's protocol ID
- REC/RCR & AHS/23/0563
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34899597Lee 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.
PubMed 32764213International 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.
PubMed 34693033Vallve-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.
PubMed 31424502Smolarz 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.
PubMed 34638893Kapoor 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.
PubMed 34769130Arafah M, Rashid S, Akhtar M. Endometriosis: A Comprehensive Review. Adv Anat Pathol. 2021 Jan;28(1):30-43. doi: 10.1097/PAP.0000000000000288.
PubMed 33044230Christ 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.
PubMed 34147493
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Wurn Technique and Mercier Therapy on Dyspareunia, Dysmenorrhea, and Quality of Life in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT06460376
- Acronym / sponsor ID
- REC/RCR & AHS/23/0563
- Conditions
- Endometriosis
- Keywords
- Dyspareunia, Dysmenorrhea, endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Endometriosis is the condition involving the presence of glands or stroma of the endometrial lining outside the uterus cavity. Its characteristics include unpleasant pain in the pelvic region, impaired fertility, pain during or after sex, and heavy bleeding during periods. Endometriosis occurs as a result of genetic, angiogenic, immunological, and inflammatory factors. In endometriosis, adhesions may be formed due to local inflammation. It can also occur as the blood-filled implants start bleeding in their surroundings. As a result of this bleeding healing occurs which causes scar formation. Pharmacologically, NSAIDS are used for instant pain relief. The most common surgical approach is laparoscopy. Physiotherapy in its various forms can be an excellent complement to the gynecological treatment of endometriosis. as previous studies also reported the effect of pelvic massage, pelvic manipulation, kinesiotherapy, and hydrotherapy. According to researcher knowledge, there is limited evidence on wurn technique and mercier therapy and how these techniques improve dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. This study aims to see the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wurn technique | Experimental | Other: Wurn TechniqueThe 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. |
| Mercier therapy | Active comparator | Other: Mercier TherapyThe 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. |
Who may qualify
- Ages
- 25 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Malignancy
- Pregnancy
- Fibroids
- Pelvic congestion syndrome
- Pelvic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wurn TechniqueTreatment: 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. | Other | Wurn technique |
| Mercier TherapyTreatment: 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 | Other | Mercier therapy |
Primary outcome
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)
1 secondary outcome
Mankoski Pain Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 34899597Koninckx 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.
- Background: PubMed 32764213Lee 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.
- Background: PubMed 34693033International 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.
- Background: PubMed 31424502Vallve-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.
- Background: PubMed 34638893Smolarz 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.
- Background: PubMed 34769130Kapoor 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.
- Background: PubMed 33044230Arafah M, Rashid S, Akhtar M. Endometriosis: A Comprehensive Review. Adv Anat Pathol. 2021 Jan;28(1):30-43. doi: 10.1097/PAP.0000000000000288.
- Background: PubMed 34147493Christ 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafiza Neelam principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wurn Technique and Mercier Therapy in people with Endometriosis, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis Health Profile Questionnaire (EHP 30) (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460376, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.