| 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
|
|
|
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
|
|
|
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:
-
To assess pain intensity before and after intervention.
-
To evaluate functional disability related to low back pain.
-
To examine changes in foot posture and pronation control.
-
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:
-
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 |