| CTRI Number |
CTRI/2025/07/090266 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [MULTIMODAL ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of multidisciplinary programme on chronic pelvic pain |
|
Scientific Title of Study
|
Multidisciplinary programme of care for women with endometriosis and its effect on chronic pelvic pain and quality of life-A Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrita Gaurav |
| Designation |
Additional Professor |
| Affiliation |
Department of Obstetrics and Gynaecology |
| Address |
Department of Obstetrics and Gynecology
All India institute of medical sciences, Rishikesh, Veerbhadra Marg, Pashulok
Uttarakhand-249201
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8171025511 |
| Fax |
|
| Email |
aamrity@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Gaurav |
| Designation |
Additional Professor |
| Affiliation |
Department of Obstetrics and Gynaecology |
| Address |
Department of Obstetrics and Gynaecology
All India institute of medical sciences, Rishikesh, Veerbhadra Marg, Pashulok-249201
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8171025511 |
| Fax |
|
| Email |
aamrity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Gaurav |
| Designation |
Additional Professor |
| Affiliation |
Department of Obstetrics and Gynaecology |
| Address |
Department of Obstetrics and gynaecology, All India institute of medical sciences, Rishikesh, Veerbhadra Marg, pashulok- 249201
Dehradun
UTTARANCHAL
249201
India |
| Phone |
8171025511 |
| Fax |
|
| Email |
aamrity@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of medical research |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707
Fax: 91-11-26588662
Email:icmrhqds[at]sansad[dot]nic[dot]in |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amrita Gaurav |
All India institute of medical sciences, Rishikesh |
department of Obstetrics and Gynecology
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL |
8171025511
aamrity@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAIIMSRISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal management |
1.Standard of care
2.Psychological intervention program
3.PELVIC floor muscle therapy
Duration of intervention 12 weeks
|
| Comparator Agent |
Standard of Care |
The Control group will receive traditional single mode approach (medical/surgical treatment). They will receive disease specific standard of care as per Standard Guidelines. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
47.00 Year(s) |
| Gender |
Female |
| Details |
Surgery or MRI confirmed Endometriosis with moderate to severe chronic pelvic pain with NPRS more than 5 |
|
| ExclusionCriteria |
| Details |
(a)Not consenting for the study
(b)Serious physical pain diseases
(e.g., fibromyalgia, Crohn’s disease, Colitis Ulcerosa),
(b) Severe psychiatric diagnosis,
(c) Pregnancy or planned pregnancy during the study period,
(d) Estimated lack of mental or physical surplus to enter into a psychological treatment or cultural barriers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Pain severity using Numerical pain rating scale NPRS (0-10) in both Intervention and Control arm.
2. Assessment of Quality of life using WHOQOL-Bref questionnaire at in both Intervention and Control arm
|
1. At baseline , 6 and 12 weeks of the study in both Intervention and Control arm.
2. At baseline and 12 weeks of the study in both Intervention and Control arm
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Hematological & Biochemical parameters
|
At baseline & 12 weeks of the study & at 3 month follow up.
|
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
RATIONALE OF THE STUDY: Endometriosis is a chronic, inammatory, estrogen-dependent disorder that is linked to pelvic pain, infertility, and a hampered quality of life. Typically, women with endometriosis are treated by a single physician. In this single-provider model of care, women frequently report lengthy diagnostic delays, unresolved pelvic pain, multiple laparoscopic surgeries, sequential consultations, and dissatisfaction with care overall. Multiple care team specialists with expertise in specic therapeutic areas treat patients with endometriosis and associated comorbidities in a coordinated, patient-centered manner. Novelty: The present study aims to study the eect of a multidisciplinary program of care on chronic pelvic pain and overall quality of life in women with endometriosis. There is a paucity of prospective randomized control trials. addressing this aspect of treatment, and there are no similar studies in the Indian population. OBJECTIVES- PRIMARY OBJECTIVES to study the eect of a multidisciplinary program of care on chronic pelvic pain and overall quality of life in women with endometriosis. . SECONDARY OBJECTIVES 1. To study the eect of a multidisciplinary program of care on hematological and biochemical parameters in women with endometriosis. 2. To perform next-generation sequencing analyses targeting novel variants of endometriosis in treatment-resistant patients. METHODS- Study design: open label A randomized controlled trial Study site- 1. Department of Obstetrics and Gynecology, AIIMS Rishikesh, in collaboration with the Department of Physical Medicine and Rehabilitation, the Department of Biochemistry, Intervention Arm: Multidisciplinary program of care along with standard of care treatment Control Arm: Standard of Care Treatment OUTCOMES - 1. Assessment of pain severity using the numerical pain rating scale NPRS (0–10) at 0, 6, and 12 weeks of the study in both the intervention and control arms. 2. Assessment of quality of life using the WHOQOL-Bref questionnaire at 0 and 12 weeks of the study in both the intervention and control arms 3. Assessment of hematological and biochemical parameters at 0 and 12 weeks of the study |