| CTRI Number |
CTRI/2025/12/098856 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of hip Strengthening Exercises to Reduce Shin Pain and Improve Leg Function |
|
Scientific Title of Study
|
Effects of hip muscle strengthening exercises on
Pain, Functional ability and Biomechanical characteristics in subjects with MEDIAL
TIBIAL STRESS SYNDROME |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAHALAKSHMI S |
| Designation |
Associate Professor |
| Affiliation |
RVS College of Physiotherapy |
| Address |
RVS College of Physiotherapy, Department of Musculoskeletal and sports Physiotherapy,
Room No 111
Sulur,
Coimbatore 641402
Tamil Nadu.
Coimbatore
TAMIL NADU
641402
India |
| Phone |
7548816116 |
| Fax |
|
| Email |
mahasusila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAHALAKSHMI S |
| Designation |
Associate Professor |
| Affiliation |
RVS College of Physiotherapy |
| Address |
RVS College of Physiotherapy, Department of Musculoskeletal and sports Physiotherapy,
Room No 111
Sulur,
Coimbatore 641402
Tamil Nadu.
Coimbatore
TAMIL NADU
641402
India |
| Phone |
7548816116 |
| Fax |
|
| Email |
mahasusila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAHALAKSHMI S |
| Designation |
Associate Professor |
| Affiliation |
RVS College of Physiotherapy |
| Address |
RVS College of Physiotherapy, Department of Musculoskeletal and sports Physiotherapy,
Room No 111
Sulur,
Coimbatore 641402
Tamil Nadu.
Coimbatore
TAMIL NADU
641402
India |
| Phone |
7548816116 |
| Fax |
|
| Email |
mahasusila@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MAHALAKSHMI S |
| Address |
RVS College of Physiotherapy, Department of Musculoskeletal and sports Physiotherapy,
Room No 111
Sulur,
Coimbatore 641402
Tamil Nadu.
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mahalakshmi S |
KMCH Hospital |
242-B,Trichy Road, Sulur, Coimbatore-641402
Coimbatore
TAMIL NADU |
7548816116
mahasusila@gmail.com |
| Mahalakshmi S |
Physiotherapy Out Patient Department |
RVS College of Physiotherapy, Department of Musculoskeletal and sports Physiotherapy,
Room No 111
Sulur,
Coimbatore 641402
Tamil Nadu.
Coimbatore
TAMIL NADU |
7458816116
mahasusila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee RVS College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional group |
Control group will receive following exercises_
Standard exercises
_ intrinsic foot muscle Strengthening exercises
1. Foot adduction exercise
2. Foot supination exercise
3. Short foot exercise
_off the-shelf basic foot orthotic (BFO)
_ Calf stretches.
All the above exercises will be given for 3-5sessions/week
for 6 weeks |
| Intervention |
Experimental group |
Experimental group will receive following exercises_ Hip strengthening exercise
and intrinsic foot muscle
Strengthening exercises
-off the-shelf basic foot orthotic
_ Calf stretches. In above treatment plan
Hip muscle strengthening
exercises will be
1. Side-Lying Hip Abduction with Hip Internal Rotation
2. Clamshell exercise 3. Hip hitches.
Intrinsic foot muscle strengthening exercises will be
1. Foot adduction exercise
2. Foot supination exercise
3. Short foot exercise
All the above exercise will be given for 3-5sessions/week
for 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed with Medial Tibial Stress
Syndrome subjects.
2. Subjects those who diagnosed with physical
examination criteria for MTSS, as outlined by
Kortebein PM10.
3. Subjects with positive one leg hop test. |
|
| ExclusionCriteria |
| Details |
1. History of surgical procedures around the knee and
ankle.
2. Genu varum or valgum deformity or hyperextended
knee.
3. Lower limb length discrepancy.
4. Recent soft tissue lesions around knee and ankle
joints.
5. Recent fracture and deformities of lower limb.
6. Sciatica patients.
7. Central nervous system dysfunction.
8. Neurological disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected results of the study analyzing the effect of hip strengthening exercises on pain,
functional ability and biomechanical characteristic in medial tibial stress syndrome subjects. Hip strengthening exercises along with conventional treatment provide better stability to the pelvis
and lower limbs during weight-bearing activities. This stability can help distribute forces more
evenly throughout the lower body, reducing the strain on the shins. Hip strengthening exercises can play a crucial role in managing MTSS by improving the
biomechanical characteristics of lower extremity. Weakness or imbalance in the hip muscles can
lead to altered lower limb mechanics during activities like running or jumping. Strengthening the
hip muscles can help correct these biomechanical abnormalities, reducing the excessive stress on
the tibia. |
pre test measurement at zero week and post test measurement after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
24/12/2025 |
| 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="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
|
The study investigates the effects of hip muscle strengthening exercises on pain, functional ability, navicular drop height, and plantar pressure in subjects with medial tibial stress syndrome . MTSS is a common overuse injury characterized by pain along the medial border of the tibia, often affecting runners and active individuals. The condition is linked to biomechanical factors such as overpronation and hip muscle weakness, which can alter lower limb alignment and mechanics.
The research is designed as an experimental study involving 70 clinically diagnosed MTSS subjects divided into two groups. Group A receives hip muscle strengthening exercises along with intrinsic foot muscle strengthening, while Group B receives only intrinsic foot muscle strengthening exercises. The intervention aims to assess pain relief, improvement in functional ability measured by a functional disability scale, changes in navicular drop height, and plantar pressure distribution using pressure sensor footwear.
Measurements include pain pressure threshold using algometry, functional ability via the Lower Extremity Functional Scale , navicular drop test for foot posture, and plantar pressure analysis across six foot regions on various inclined planes. The hypothesis tests whether hip muscle strengthening combined with conventional treatment significantly improves these parameters compared to conventional treatment alone.
The study setting is at R.V.S. College of Physiotherapy outpatient department, with a one-year duration. Ethical clearance has been obtained, and participant consent will be ensured. This research aims to provide evidence for incorporating hip strengthening in MTSS rehabilitation to optimize pain management and biomechanical function.
This summary encapsulates the study’s background, purpose, methodology, and expected outcomes in addressing MTSS through targeted hip muscle exercises. |