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CTRI Number  CTRI/2025/04/085203 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 12/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Chronic Pain Management with Mobile App at Primary Healthcare Centres 
Scientific Title of Study   Artificial Intelligence-Driven Chronic Pain Management with Mobile App Integration for Empowering Primary Healthcare Physicians 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujeet Kumar Singh Gautam 
Designation  Professor 
Affiliation  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  A block, Room no. 17, Department of Anaesthesiology, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222495527  
Fax    
Email  docsksg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sujeet Kumar Singh Gautam 
Designation  Professor 
Affiliation  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  A block, Room no. 17, Department of Anaesthesiology, SGPGIMS, Lucknow


UTTAR PRADESH
226014
India 
Phone  05222495527  
Fax    
Email  docsksg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sujeet Kumar Singh Gautam 
Designation  Professor 
Affiliation  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  A block, Room no. 17, Department of Anaesthesiology, SGPGIMS, Lucknow


UTTAR PRADESH
226014
India 
Phone  05222495527  
Fax    
Email  docsksg@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  SGPGIMS, Raibareli Road, Lucknow-226014 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujeet Kumar Singh Gautam  Sanjay Gandhi Post-graduate Institute of Medical Sciences  Pain Clinic, Department of Anaesthesiology, SGPGIMS
Lucknow
UTTAR PRADESH 
9839048754

docsksg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with chronic pain diseases 
 
ExclusionCriteria 
Details  Patient Refusal
Patients with following red flag conditions:
Malignancy
Motor deficit or progressive neurological deficit
Osteoporosis
Trauma
Infection
Immunosuppression
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Probability of provision of correct diagnosis and management by app  2-3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Primary care physician satisfaction  2-3 years 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   01/12/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Rationale: Chronic pain affects 20-30% of the population, often untreated due to a lack of specialists. This project aims to bridge this gap by developing a mobile app integrated with artificial intelligence (AI), empowering primary care physicians in diagnosing and managing chronic pain.

 

Study Design:

Pilot Study.

 

Inclusion Criteria:

Patients with chronic pain diseases will be enrolled to prepare clinical feature databank and pilot testing of the app; chronic pain diseases that will be included are listed at the end of proposal

Exclusion Criteria:

Patient Refusal

Patients with following red flag conditions:

Malignancy

Motor deficit or progressive neurological deficit 

Osteoporosis

Trauma

Infection

Immunosuppression

 

Objectives:

Develop an AI-based mobile app capable of diagnosing and managing chronic-pain diseases.

Evaluate the feasibility of chronic-pain management by primary care physicians using the AI-based app.

Establish a clinical feature databank of prevalent chronic-pain conditions in India to support the app’s algorithm.

 

Methods: A multidisciplinary team will develop an AI-based mobile app for chronic-pain management, utilizing advanced deep-learning and machine-learning techniques. Pain specialists will categorize conditions and use clinical data to train the algorithm. Advanced deep-learning models like CNNs, transformers, attention models and RNNs will extract patterns. Pilot studies will assess primary care physicians’ ability to manage chronic-pain using the app, supported by training modules. The project aims to deliver an AI-powered app and promote AI adoption in medical sciences, particularly in Uttar Pradesh, with accompanying AI lab facilities.

 

Expected Outcomes:

Development of an AI-based mobile-app for diagnosing and managing chronic-pain diseases.

Establishment of AI lab facilities at SGPGIMS, Lucknow.

Creation of training modules to raise awareness of AI’s application in medical sciences, particularly in Uttar Pradesh.

 

Outcome Measures:

Primary Outcome Measure: Probability of provision of correct diagnosis and management by app

Secondary Outcome measures: Primary care physician satisfaction

 

Sample size estimation and sampling strategy:

Based on the data reported at different centres, about 20-30% patients are diagnosed with chronic pain among the individuals seeking treatment for the pain. Taking the incidence of 20%, at minimum two-sided 95% confidence interval and 20% relative error in the reported incidence, required at least 385 patients. Considering the possible data loss and to increase the accuracy of the findings, 500 subjects will be included in the study. Power analysis and sample size version-16 (PASS-16, NCSS) was used for the sample size estimation.

For the validation of app, further 100 consecutive eligible patients will be enrolled.

Chronic Pain Diseases:

Head and Neck

Migraine

Tension headache

Trigeminal autonomic cephalalgias

Occipital Neuralgia

Neck:

 Cervical facet pain

Myofascial pain

Cervical disc prolapse

 Cervical spondylitis

 Face:

Trigeminal Neuralgia

Atypical Facial pain

Trigeminal neuropathy

Post-herpetic neuralgia

Glossopharyngeal neuralgia

Upper Back:

 Myofascial pain

Vertebral compression fracture

Nerve entrapment pain

Thoracic facet joint pain

Chest

Chest wall pain

Nerve entrapment pain

Myofascial pain

Post-herpetic neuralgia

Lower Back

 Facet joint pain

Sacro-iliac joint pain

Myofascial pain

Vertebral compression fracture

Lumbar disc prolapse

Abdomen

Antero-cutaneous nerve entrapment pain

Myofascial pain

Scar neuralgia

Bladder pain syndrome

Upper limb

 Frozen shoulder

Cervical disc prolapse

Cervical facet joint pain

Myofascial pain

Sympathetic pain

Lower limb:

Lumbar disc prolapse

umbar facet joint pain

Myofascial pain

Sympathetic pain

Joint Pain (Knee, shoulder and other joints)

Osteoarthritis

Rheumatoid arthritis

Ankylosing spondylitis

 
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