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CTRI Number  CTRI/2026/02/103656 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
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   Effect of Foot Muscle Strengthening on Mechanical Low Back Pain in Nurses with Pronated Feet 
Scientific Title of Study   Effect of tibialis posterior strengthening program on reducing mechanical low back pain in nursing staff with pronated feet: A Randomized Controlled Trail 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghana Palkhade 
Designation  Associate Professor 
Affiliation  BKL Walawalkar College of Physiotherapy 
Address  BKL Walawalkar College of Physiotherapy Kasarwadi Sawarde Chiplun Ratnagiri Maharashtra – 415606
BKL Walawalkar College of Physiotherapy Kasarwadi Sawarde Chiplun Ratnagiri Maharashtra – 415606
Ratnagiri
MAHARASHTRA
415606
India 
Phone  8999098178  
Fax    
Email  drmeghanapt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nilambari Narendra Vichare 
Designation  PG Student 
Affiliation  BKL Walawalkar College of Physiotherapy 
Address  BKL Walawalkar College of Physiotherapy Chiplun Sawarde 415606
BKL Walawalkar College of Physiotherapy Kasarwadi Sawarde Chiplun Ratnagiri Maharashtra – 415606
Ratnagiri
MAHARASHTRA
415606
India 
Phone  8369033582  
Fax    
Email  vicharenilambari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nilambari Narendra Vichare 
Designation  PG Student 
Affiliation  BKL Walawalkar College of Physiotherapy 
Address  BKL Walawalkar College of Physiotherapy Chiplun Sawarde 415606
BKL Walawalkar College of Physiotherapy Kasarwadi Sawarde Chiplun Ratnagiri Maharashtra – 415606
Ratnagiri
MAHARASHTRA
415606
India 
Phone  8369033582  
Fax    
Email  vicharenilambari@gmail.com  
 
Source of Monetary or Material Support  
BKL Walawalkar College of Physiotherapy sawarde chiplun 415606 India  
 
Primary Sponsor  
Name  Nilambari Vichare  
Address  BKL Walawalkar College of Physiotherapy Chiplun Sawarde 415606 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nilambari Narendra Vichare  BKL Walawalkar College of Physiotherapy  BKL Walawalkar College of Physiotherapy Chiplun Sawarde 415606
Ratnagiri
MAHARASHTRA 
8369033582

vicharenilambari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  flat feet with Lower back pain  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator group Conventional low back pain rehabilitation only Six weeks duration three sessions per week Includes routine physiotherapy for mechanical low back pain such as core stabilization lumbar mobility stretching and ergonomic advice without specific tibialis posterior strengthening  Group B control conventional low back pain rehab only Duration six weeks Frequency three sessions per week Session time twenty to thirty minutes Warm up gentle trunk mobility and stretching Core strengthening abdominal bracing pelvic tilts bridging lumbar stabilization Back extensor and flexibility exercises hamstring and back stretching Posture correction and ergonomic training 
Intervention  Intervention group Tibialis posterior strengthening program plus conventional low back pain rehabilitation Six weeks duration three sessions per week Includes short foot exercise towel curls heel raises resisted tibialis posterior exercises eccentric heel raises and routine low back pain physiotherapy such as core strengthening stretching posture training   Group A Tibialis posterior strengthening plus conventional low back pain rehab Duration six weeks Frequency three sessions per week Session time twenty to thirty minutes Weeks one to three activation phase Warm up ankle rotations seated foot doming short foot exercise toe curls with towel Strengthening heel raises with towel under toes Cool down calf stretching gastrocnemius and soleus Weeks three to six progression phase Warm up ankle rotations seated foot doming short foot exercise toe curls with towel Strengthening resisted tibialis posterior with resistance band eccentric heel raises on step Cool down posterior chain stretching calves hamstrings lower back Conventional low back program for group A Core activation pelvic tilts abdominal bracing lumbar stabilization exercises back mobility stretching and ergonomic advice  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Nursing staff aged 25–50 years
Diagnosed with mechanical low back pain for at least
three months. 
 
ExclusionCriteria 
Details  History of lower limb or spinal surgery.
Neurological conditions affecting gait or posture.
Recent lower limb injury or musculoskeletal
disorders other than pronation.
Pregnancy or systemic diseases affecting
musculoskeletal function.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale (NPRS)  Baseline and after 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index (ODI), Navicular Drop Test (NDT)  Baseline and after 6 weeks 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   21/02/2026 
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="6"
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  

Title:
Effect of Tibialis Posterior Strengthening Program on Reducing Mechanical Low Back Pain in Nursing Staff with Pronated Feet: A Randomized Controlled Trial

Background:
Nursing staff often experience mechanical low back pain (MLBP) due to prolonged standing, walking, lifting patients, and poor lower-limb biomechanics. Pronated feet can alter lower-limb alignment, increase tibial internal rotation, and affect pelvic and lumbar mechanics, thereby contributing to low back pain. The tibialis posterior muscle plays a key role in maintaining the medial longitudinal arch and controlling pronation. Strengthening this muscle may improve foot alignment and reduce stress on the lumbar spine.

Aim:
To determine the effectiveness of a tibialis posterior strengthening program in reducing mechanical low back pain among nursing staff with pronated feet.

Objectives:

  1. To assess pain intensity before and after intervention.

  2. To evaluate functional disability related to low back pain.

  3. To examine changes in foot posture and pronation control.

  4. To compare outcomes between experimental and control groups.

Methodology:

  • Design: Randomized controlled trial.

  • Participants: Nursing staff with mechanical low back pain and pronated feet (based on foot posture index/navicular drop test).

  • Sample: Participants randomly divided into:

    • Experimental group – received tibialis posterior strengthening + conventional physiotherapy.

    • Control group – received only conventional physiotherapy or general exercises.

  • Intervention duration: 6 weeks 3 sessions/week

  • Outcome measures:

    • Pain: Numerical Rating Scale (NPRS)

    • Disability: Oswestry Disability Index (ODI) or Roland-Morris Questionnaire

    • Foot posture: Navicular drop test 

Intervention (Experimental):
Specific tibialis posterior strengthening exercises such as:

  • Resisted foot inversion with plantarflexion

  • Heel raises with medial arch support

  • Short foot exercises

  • Functional weight-bearing strengthening

 
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