| CTRI Number |
CTRI/2025/07/091361 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective cohort study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding nerve related pain in lower limb injuries that are not caused by accidents how common it is and what factors are linked to it |
|
Scientific Title of Study
|
Analysis of neuropathic pain in nontraumatic lower limb musculoskeletal injuries Prevalence and associated factors |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharun Vidya Dsouza |
| Designation |
Student |
| Affiliation |
AlVAS COLLEGE OF PHYSIOTHERAPY |
| Address |
Out Patient Department Department of Physiotherapy Alvas Health Centre Alvas Health Centre Complex Alvas Health Centre Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9980101134 |
| Fax |
|
| Email |
sharunvidya90@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
AMRATHA G SHETTY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AlVAS COLLEGE OF PHYSIOTHERAPY |
| Address |
Out Patient Department Department of Physiotherapy Alvas Health Centre Alvas Health Centre Complex Alvas Health Centre Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9945208205 |
| Fax |
|
| Email |
amrathagshetty@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sharun Vidya Dsouza |
| Designation |
Student |
| Affiliation |
AlVAS COLLEGE OF PHYSIOTHERAPY |
| Address |
Out Patient Department Department of Physiotherapy Alvas Health Centre Alvas Health Centre Complex Alvas Health Centre Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9980101134 |
| Fax |
|
| Email |
sharunvidya90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College Of Physiotherapy Out Patient Musculoskeletal Department |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 0 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALVAS COLLEGE OF PHYSIOTHERAPY ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults between the age if 18 and 65;The ability to think with sufficient clarity to accurately fill out pain questionnaire; The identification of non traumatic injuries to the lower extremities; The participant must consent in order to participate |
|
| ExclusionCriteria |
| Details |
A history of recurring discomfort that has no connection to the present musculoskeletal condition; Comorbid condition in the system such as GB syndrome DM; Deficiencies with particular vitamins may trigger neuropathy; Psychosocial conditions that were identified prior to or following musculoskeletal pain commenced; History of surgery or trauma related to lower extremities; Medication for persistent neuropathic pain; Confounding comorbidities are becoming more common in people over 65; Declining to participate in the research |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain DETECT questionnaire;
The hospital and depression scale; Pain catastrophizing scale |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
18/08/2025 |
| 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="0" Months="8" 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
|
Neuropathic pain (NP) is a type of pain that originates from damage or dysfunction within the nervous system. Unlike typical musculoskeletal pain, which is often mechanical or inflammatory in nature, NP can present as burning, tingling, or electric shock-like sensations, often without any visible injury. In clinical practice, this form of pain is frequently under recognized, especially in individuals with nontraumatic musculoskeletal (MSK) conditions such as tendinopathies, plantar fasciitis, patellofemoral pain, and osteoarthritis of the lower limbs. Many patients continue to experience discomfort even during or after standard physiotherapy treatments. One possible reason for this persistent pain is the overlooked presence of a neuropathic component, which is not routinely screened for during conventional MSK assessments. This can lead to incomplete recovery, prolonged suffering, and frustration for both patients and healthcare providers.This study aims to assess how commonly NP occurs in nontraumatic lower limb MSK injuries and to explore the various risk factors that may be linked with it. These include lifestyle and psychosocial factors like physical inactivity, obesity, smoking, poor sleep quality, emotional distress, and anxiety or depression all of which may contribute to pain becoming chronic through central sensitization. To evaluate this, patients will be assessed through validated tools such as the painDETECT questionnaire, the Pain Catastrophizing Scale (PCS), and the Hospital Anxiety and Depression Scale (HADS), alongside clinical tests for nerve sensitivity and physical function. These tools help differentiate between nociceptive (mechanical) and neuropathic pain origins and provide insight into psychological influences on pain perception. By identifying the hidden neuropathic pain component in MSK conditions, this study aims to support a more mechanism based, individualized approach to physiotherapy. This shift is crucial, as unrecognized NP can lead to prolonged suffering, patient dissatisfaction, and incomplete recovery. Ultimately, the research hopes to empower physiotherapists with better screening strategies to offer more effective and targeted rehabilitation. Ultimately, this research addresses a critical gap in physiotherapy practice by emphasizing the need to identify hidden neuropathic components in musculoskeletal pain for better, individualized patient care. |