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CTRI Number  CTRI/2024/12/077964 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Physiotherapy treatment for low back pain in women after cesarean delivery 
Scientific Title of Study   Efficacy of muscle energy technique versus core stabilization exercise in the management of postpartum low back pain in women after cesarean section 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskaan Kumar  
Designation  Research Scholar 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313)

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9821033897  
Fax    
Email  muskaan.delhi2584@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjib Kumar Das 
Designation  Associate Professor 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313)

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  8879485847  
Fax    
Email  skdas@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sanjib Kumar Das 
Designation  Associate Professor 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313)

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  8879485847  
Fax    
Email  skdas@amity.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh Pin 201313 INDIA 
 
Primary Sponsor  
Name  Muskaan Kumar  
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sanjib Kumar Das  Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Muskaan Kumar   Amity Institute of Health Allied Sciences  Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh Pin 201313 INDIA
Gautam Buddha Nagar
UTTAR PRADESH 		 9821033897

muskaan.delhi2584@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional NTCC Committee Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain, (2) ICD-10 Condition: O268||Other specified pregnancy relatedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core Stabilization Exercise   Three levels of core Stabilization exercise given to patient for 3 weeks Frequency: 4 sessions per week, 2 sets per session, with 10 repetitions and a 10-second hold for each exercise. • Level 1 (Weeks 1): Abdominal draw-in with single knee-to-chest, heel slides, and double knee-to-chest. Supine twist, prone bridging on elbows, supine bridging with arms at the side or crossed on the chest, single-leg lift. • Level 2 (Weeks 2): Abdominal draw-in with feet on a Swiss ball, supine dead bug. Prone bridging on elbows with leg extension, side bridging with single-leg abduction, quadruped position with opposite leg raise. • Level 3 (Weeks 3): Prone bridging, side bridging with hip abduction, flexion, and extension movements, and bridging with head supported on a physio ball.  
Comparator Agent  Muscle Energy Technique  The intervention targets three primary muscles: Quadratus Lumborum, Erector Spinae, and Abdominal muscles (Transverse and Rectus Abdominis), with a dosage of four sessions per week on alternate days. Each session involves positioning the muscle to its restriction barrier, followed by the patient applying 30% effort against the therapists resistance for 7–10 seconds while exhaling. The therapist then moves the muscle to a new restriction barrier and holds the position for 10–60 seconds, performing 3–5 repetitions. For the Quadratus Lumborum, the patient lies sideways, extending their upper arm overhead and raising their upper leg until the muscle activates. During exhalation, the therapist stretches the pelvis away from the lower ribs for 30 seconds. For the Erector Spinae, the patient sits while the therapist guides flexion, side bending, and rotation. The patient looks in the direction of rotation, holding their breath for 7–10 seconds. For Abdominal muscles, the therapist assists the patient in engaging restrictive barriers through trunk movements, applying 20–30% isometric contractions for 5–10 repetitions, each held for 30 seconds. This process is repeated until improved movement is achieved, progressively addressing the limiting factors. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Postpartum women who have undergone C-section with healed incision without any postoperative complications and are within the postpartum phase (up to 1 year of post-delivery).
2. Age Range: Women between 25- and 40-year-old.
3. Women diagnosed with postpartum low back pain minimum 1 month following Cesarean delivery.
4. Women willing to participate in the study and commit to regular follow-up for the intervention period.
5. No Prior Physiotherapy for Low Back Pain, Women who have not previously undergone MET or Core Stabilization Exercises for postpartum low back pain.
6. Women who have poor core strength and can perform MET and Core Stabilization Exercises.

 
 
ExclusionCriteria 
Details  1. Women having low back pain for less than 1 month.
2. Women who have complications during or after Cesarean delivery that would contraindicate physical exercise (e.g., severe hemorrhage, infection, or ongoing complications).
3. Women with pre-existing neurological deficits, spinal surgery, or orthopedic conditions (for example: lumbar stenosis, spondylitis, spondylolisthesis, lumbar radiculopathy, fracture, herniated lumbar disc, rheumatoid arthritis, osteoporosis, psychological disorder or physical disability) affecting their ability to perform MET or Core Stabilization Exercises.
4. Women whose low back pain is due to causes unrelated to postpartum changes, such as herniated discs, tumors, or infections.
5. Women currently participating in another study related to postpartum rehabilitation or low back pain.
6. Women unwilling to follow the study protocol or attend follow-up sessions regularly.
 
 
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 
Pain, Functional disability with low back pain, Strength And Stability   Baseline assessment - before intervention
Follow up assessment - after 4 sessions till 3 weeks
Final assessment - 12th Day (3rd week)  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   30/12/2024 
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="4"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [muskaan.delhi2584@gmail.com].

  6. For how long will this data be available start date provided 06-12-2025 and end date provided 05-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Lower back discomfort is frequently experienced by postpartum women, especially those who have had caesarean sections, as a result of postural alterations, changed biomechanics, and weak core muscles. Although there is no data comparing the effectiveness of Muscle Energy Technique versus Core Stabilization Exercises in post-cesarean populations, both are frequently utilized to address these problems. In order to improve treatment outcomes and guide professional practice, this study compares therapies with an emphasis on pain management, functional disability and core strength as the general postpartum recovery.

Need of the Study – Addressing the high incidence of low back pain following caesarean sections in women requires the investigation. Although widely used, there is not enough data to compare the benefits of Muscle Energy Technique (MET) and core stabilization exercises in this particular demographic. Whichever method provides the best pain relief and improves core strength with improved functional disability will be recognized, and this knowledge will improve postpartum rehabilitation results, and direct clinical practice.

Aim – The study aims to compare the effectiveness of Core Stabilization Exercises and Muscle Energy Technique (MET) in treating postpartum low back pain in women after Cesarean sections.

 

Objectives –

1.     To evaluate the efficacy of Muscle Energy Technique (MET) in reducing postpartum low back pain in women after Cesarean section.

2.     To evaluate the effectiveness of Core Stabilization Exercises (CSE) in managing postpartum low back pain in women following Cesarean section.


Hypothesis –  

  • Null Hypothesis (Hâ‚€): There is no significant correlation in pain relief outcomes between Muscle Energy Technique (MET) and Core Stabilization Exercises in postpartum women after Cesarean section.
  • Alternative Hypothesis (H₁): There is a significant correlation in pain relief outcomes between Muscle Energy Technique (MET) and Core Stabilization Exercises in postpartum women after Cesarean section.


 
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