| CTRI Number |
CTRI/2026/02/104084 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Managing Pelvic Pain After Childbirth in First-Time Mothers Through Pain Awareness and Physiotherapy |
|
Scientific Title of Study
|
Effectiveness of Pain education with Multimodal Physiotherapy on Pain and
Quality of Life, in Primiparous Women with Postpartum Pelvic Girdle Pain: A Randomized
Controlled 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 Suma P Patil |
| Designation |
Assistant Professor Phd Scholar |
| Affiliation |
KAHER (Deemed to be University) Belagavi |
| Address |
Room no. 6,Department of CBR
Physiotherapy,KLE JGMM Medical College, Gabbur Cross
District-Dharwad
City -Hubballi
Karnataka
India - 580020
Dharwad
KARNATAKA
580028
India |
| Phone |
8310212992 |
| Fax |
|
| Email |
drsumap23@kledeemeduniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Mukkannavar |
| Designation |
Professor & Principal HOD of Orthopedic Physiotherapy |
| Affiliation |
KAHER (Deemed to be University) Belagavi |
| Address |
Department of Orthopedic Physiotherapy KLE College of
Physiotherapy Near Kundgol Cross Kotagundhshi Gabbur
Dharwad
KARNATAKA
580028
India
Dharwad
KARNATAKA
580028
India |
| Phone |
9448231520 |
| Fax |
|
| Email |
drprashantm@kledeemeduniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suma P Patil |
| Designation |
Assistant Professor Phd Scholar |
| Affiliation |
KAHER (Deemed-to-be- University), Belagavi |
| Address |
Room no. 6,Department of CBR
Physiotherapy,KLE JGMM Medical College, Gabbur Cross
District-Dharwad
City -Hubballi
Karnataka
India - 580020
Dharwad
KARNATAKA
580028
India |
| Phone |
8310212992 |
| Fax |
|
| Email |
drsumap23@kledeemeduniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Suma P Patil |
| Address |
Room no. 6,Department of CBR
Physiotherapy,KLE JGMM Medical College, Gabbur Cross
District-Dharwad
City -Hubballi
Karnataka
India - 580020 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Suma P Patil |
KLE Jagadguru Gangadhar Mahaswamigalu Moorusaviramath Medical College and Hospital |
Department of
CBR
Physiotherapy,
Room no. 6,
Gabbur Cross,
Hubballi,
Karnataka,
India - 580020
Dharwad
KARNATAKA
Dharwad
KARNATAKA |
08310212992
drsumap23@kledeemeduniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE VK INSTITUTE OF DENTAL SCIENCE BELAGAVI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multimodal Physiotherapy Group |
Participants will receive Multimodal Physiotherapy alone for 8 weeks, consisting of TENS and the same tailored exercise program focusing on lumbopelvic stabilization, strengthening, flexibility, and functional rehabilitation, without structured Pain Education. |
| Intervention |
Pain Education + Multimodal Physiotherapy Group |
Participants will receive structured Pain Education combined with Multimodal Physiotherapy for 8 weeks. Pain Education will be delivered three times per week (10–15 minutes per session) focusing on pain mechanisms, ergonomics, self-management strategies, fear-avoidance reduction, and activity modification. Multimodal Physiotherapy will include TENS and a tailored exercise program |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
i Primiparous women with aged from 20-35 years
ii Postpartum women diagnosed with Pelvic Girdle Pain as per APTA clinical guidelines characterized by pain in the posterior pelvis (sacroiliac joint region) and/or anterior pubic symphysis with a pain intensity of greater then or equal to 4 on the Visual Analog Scale (VAS)
Pain must be aggravated by movement and confirmed by at least two positive pelvic girdle provocation tests as outlined in the Clinical Practice Guidelines by the Academy of Pelvic Health Physical Therapy (2022)
iii Willing to provide informed consent and participate in the Study
|
|
| ExclusionCriteria |
| Details |
i Women with a history of Pelvic trauma Spinal Surgery or any Musculoskeletal or Neurological disorders affecting the pelvis or lower limbs as well as those with serious medical conditions such as Cancer Inflammatory Arthritis or Recent fractures
ii High-risk obstetric conditions that could pose health risks or require different postpartum recovery protocols.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale (VAS 100mm)-VAS
SF-36 Quality of life questionnaire
|
0 6 8 (3 times) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oswestry disability index (ODI 2.0)-
Pain Catastrophizing scale
Tampa Scale of Kinesiophobia (TSK)
|
0 6 8 (3 times) |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="1"
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
|
This randomized controlled trial aims to evaluate the effectiveness of structured Pain Education combined with Multimodal Physiotherapy compared to Multimodal Physiotherapy alone in primiparous women with postpartum pelvic girdle pain (PP-PGP). Postpartum pelvic girdle pain is a common musculoskeletal condition that can significantly affect mobility, daily activities, psychological well-being, and quality of life in first-time mothers.A total of 96 eligible participants aged 20–35 years will be randomly allocated into two groups. Group A will receive Pain Education along with Multimodal Physiotherapy, while Group B will receive Multimodal Physiotherapy alone. The intervention will be conducted over 8 weeks. Primary outcomes include pain intensity (Visual Analog Scale) and quality of life (SF-36). Secondary outcomes include disability (Oswestry Disability Index), pain catastrophizing (Pain Catastrophizing Scale), and kinesiophobia (Tampa Scale for Kinesiophobia). Assessments will be performed at baseline, 6 weeks, and 8 weeks. The study aims to determine whether integrating Pain Education into physiotherapy provides additional benefits in reducing pain, improving psychological factors, and enhancing overall quality of life in primiparous women with PP-PGP. |