| CTRI Number |
CTRI/2025/07/090723 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Calf Muscle Pain in Diabetic Neuropathy |
|
Scientific Title of Study
|
A Comparative study to find the effectiveness of myofascial release over conventional exercise on calif muscle pain
and functional activities in diabetic neuropathy patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARAVANAN |
| Designation |
Research Scholar |
| Affiliation |
Dr MGR Educational and Research Institute |
| Address |
Faculty Of Physiotherapy
poonamalli High road
Velappanchavadi
PhysioPlus
Appu Street
mylapore
Chennai
TAMIL NADU
600077
India |
| Phone |
9444259862 |
| Fax |
|
| Email |
drsspt14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G MOHANKUMAR |
| Designation |
Professor |
| Affiliation |
Dr MGR Educational and Research institute |
| Address |
Faculty Of Physiotherapy
ACS Medical college and Hospital velappanchavadi
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9791072249 |
| Fax |
|
| Email |
mohankumar.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
SARAVANAN |
| Designation |
Research Scholar |
| Affiliation |
Dr MGR Educational and Research Institute |
| Address |
ACS Medical College and Hospital
Velappanchavadi
Chennai
PhysioPlus
73/38 Appu Street
Mylaopore
Chennai
TAMIL NADU
600077
India |
| Phone |
09444259862 |
| Fax |
|
| Email |
drsspt14@gmail.com |
|
|
Source of Monetary or Material Support
|
| college of physiotherapy ACS Medical college and Hospital, Dr MGR Educational and Research institute Velappanchavadi Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
ACS Medical College and Hospital |
| Address |
Velappanchavadi
Chennai 600077 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| SARAVANAN |
Physiotherapy OPD ACS Medical college and Hospital |
Velappanchavadi
Chennai
TAMIL NADU |
09444259862
drsspt14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F||Physical Rehabilitation and Diagnostic Audiology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercise including stretching and strengthening. |
To evaluate the effectiveness of calf muscles pain intensity strength and Functional movements of Diabetic Neuropathy patients |
| Intervention |
Myofascial Release |
To evaluate the effectiveness of myofascial release in calf muscles to reducing pain Diabetic Neuropathy patients |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 30-70 years diagnosed with type 2 diabetes mellitus.
2. Confirmed diagnosis of diabetic neuropathy (based on clinical tests like Michigan Neuropathy Screening Instrument or nerve conduction studies).
3. Presence of calf muscle dysfunction, including symptoms such as pain, stiffness, reduced strength, or limited range of motion.
4. Pain intensity in the calf region rated as greater than 4 on the Numeric Pain Rating Scale(NRS).
5. Ability to walk independently or with minimal assistance.
6. Willingness to participate and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1 Diagnosis of type 1 diabetes or other non-diabetic neuropathies
2 Presence of severe peripheral arterial disease ankle-branchial index is lesser than 0.7
3 History of lower limb fractures surgeries or conditions like Achilles tendonitis or plantar fasciitis in the past 6 months
4 Severe musculoskeletal disorders affecting the lower limbs arthritis or joint deformities
5 Any coexisting neurological conditions eg stroke multiple sclerosis) that may interfere with functional assessment
6 Active foot ulcers, infections, or other diabetic foot complications
7 Use of opioids or other strong analgesics that may alter pain perception during the study period.
8. Participation in another clinical trial or physical therapy program in the last 3 months.
9. Pregnancy or lactation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Calf Muscle Pain |
Calf Muscle Function
Improvement in muscle strength, as measured by a handheld dynamometer.
Increased range of motion (ROM) in the ankle joint, assessed using a
goniometer.
Enhanced flexibility of the calf muscles, as determined by standard flexibility
Tests.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the impact of myofascial release versus conventional exercise on pain intensity in the calf muscles, as measured by the Numeric Pain Rating Scale NRS
2 To assess the changes in functional activity using the Lower Extremity Functional Scale LEFS in both intervention groups
3 To determine the effects of the interventions on muscle stiffness & tension in the calf muscles
4 To analyses participant-reported satisfaction & perceived benefits of each intervention.
5 To investigate the potential role of myofascial release & conventional exercise in reducing the risk of falls & improving balance in individuals with diabetic neuropathy
6. To compare the long-term sustainability of the functional & pain-relief benefits provided by the two interventions
|
18 session of six week period |
Improvement in muscle strength, as measured by a handheld dynamometer.
Increased range of motion (ROM) in the ankle joint, assessed using a
goniometer.
Enhanced flexibility of the calf muscles, as determined by standard flexibility
|
LEFS
BIOTHESIOMETER
GONIOMETER |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
01/08/2025 |
| 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="0"
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
|
Aim To evaluate and compare the effectiveness of myofascial release therapy and conventional exercise in improving calf muscle function, reducing pain intensity, and enhancing functional mobility in individuals with diabetic neuropathy. Primary Objective • To compare the effectiveness of myofascial release and conventional exercise in improving calf muscle function (strength, flexibility, and range of motion) in individuals with diabetic neuropathy. Secondary Objectives To evaluate the impact of myofascial release versus conventional exercise on pain intensity in the calf muscles, as measured by the Visual Analog Scale (VAS). 2. To assess the changes in functional mobility using the Timed Up and Go (TUG) test in both intervention groups. 3. To determine the effects of the interventions on muscle stiffness and tension in the calf muscles. 4. To analyze participant-reported satisfaction and perceived benefits of each intervention. 5. To investigate the potential role of myofascial release and conventional exercise in reducing the risk of falls and improving balance in individuals with diabetic neuropathy. 6. To compare the long-term sustainability of the functional and pain-relief benefits provided by the two interventions.
|