FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close