| CTRI Number |
CTRI/2025/11/097394 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| 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
|
How Pelvic Proprioception Exercises Help Reduce Low Back Pain in Women After Multiple Pregnancies |
|
Scientific Title of Study
|
EFFECT OF PELVIC PROPRIOCEPTION TRAINING ON LOW BACK PAIN AND FUNCTIONAL MOBILITY IN MULTIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Thakur |
| Designation |
MPT |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University, Kanpur |
| Address |
School of Health Sciences Department of Physiotherapy SHS 101 CSJMU Kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7807341872 |
| Fax |
|
| Email |
dikshagautam00726@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Shukla |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University, Kanpur |
| Address |
School of Health Sciences Department of Physiotherapy SHS 101 CSJMU Kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7985159439 |
| Fax |
|
| Email |
nehacsjmu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Shukla |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University, Kanpur |
| Address |
School of Health Sciences Department of Physiotherapy SHS 101 CSJMU Kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7985159439 |
| Fax |
|
| Email |
nehacsjmu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Diksha Thakur |
| Address |
School of Health Sciences Department of Physiotherapy SHS 101 CSJMU Kanpur Nagar UTTAR PRADESH 208024 India |
| 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 Diksha Thakur |
Physiotherapy OPD 101 School of Health Sciences CSJMU Kanpur Nagar UTTAR PRADESH 208024 India |
School of Health Sciences Department of Physiotherapy-Physiotherapy OPD SHS 101 CSJMU Kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH |
7807341872
dikshagautam00726@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, Chhatrapati Shahu Ji Maharaj University, Kanpur, India, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy training |
Spinal Hyperextension 10 repetition/2-3 sets/day/week
Prone on elbow 10 repetition/2-3 sets/day/week
Abdominal exercises 10 repetition/2-3 sets/day/week |
| Intervention |
Pelvic proprioception training |
Pelvic floor exercise 10 repetition/2-3 sets/day/week
Pelvic tilt exercise 10 repetition/2-3 sets/day/week
Partial Curls10 repetition/2-3 sets/day/week
Diagonal Curls10 repetition/2-3 sets/day/week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Multiparous women
Chronic Low Back Pain
more than 6 months after Postpartum
more than 18 years age
Signed Informed Consent form |
|
| ExclusionCriteria |
| Details |
Pregnant Women
Urinary Incontinence
Any spine/Disc pathological Condition
Psychological Condition
Pelvic Inflammatory Disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| G power |
The effect size was calculated by using g power and two tailed test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain by NPRS |
At baseline & after 3 weeks of intervention & at 2 weeks follow up |
| FUNCTIONAL MOBILITY BY ODI |
At baseline & after 3 weeks of intervention & at 2 weeks follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="44"
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)
|
02/12/2025 |
| 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="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Low back pain is globally more prevalent among women, and impaired pelvic floor proprioception has been identified as a contributing factor. Women have been experiencing these issues for decades, yet the extent of impairment and its relationship with parity remains underexplored. The present study aims to determine the level of proprioceptive impairment in women with low back pain and to investigate whether parity is indirectly associated with weakened proprioception and increased incidence of LBP. Participants diagnosed with low back pain and reduced pelvic floor proprioception will be divided into two groups: one receiving conventional physiotherapy treatment and the other receiving a modified physiotherapy intervention. Baseline data will be collected prior to treatment, and outcomes will be evaluated post-intervention to compare the effectiveness of both approaches.
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