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CTRI Number  CTRI/2025/08/092334 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Heat therapy and Exercises with medicines in Chronic low back pain. 
Scientific Title of Study   Efficacy of Combination of Pharmacotherapy and Hot fomentation with Combination of lower back streching exercise and Pharmacotherapy in assessing the pain scores in patient with non-specific chronic low back pain- A prospective,randomised controlled trail. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pranav Purohit  
Designation  Junior Resident  
Affiliation  Institute of medical sciences, BHU 
Address  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9627289596  
Fax    
Email  pranav.purohit2708@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Prakash  
Designation  Professor  
Affiliation  Institute of medical sciences, BHU 
Address  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9453047154  
Fax    
Email  drshashiprakash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pranav Purohit  
Designation  Junior Resident  
Affiliation  Institute of medical sciences, BHU 
Address  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9627289596  
Fax    
Email  pranav.purohit2708@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Pranav Purohit 
Address  Junior Resident Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India Pincode-221005 
Type of Sponsor  Other [self] 
 
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 Shashi Prakash   Institute of Medical Sciences, BHU  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH 		 9453047154

drshashiprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IMS,BHU Varanasi 221005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M538||Other specified dorsopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pharmacotherapy with Hot fomentation  Patients will receive standard pharmacotherapy(Acetaminophen 500mg QID,Etoricoxib 60mg with Thiocolchiside 4mg )along with local hot fomentation applied to lower back for 20 minutes. 
Intervention  Pharmacotherapy with Stretching exercises  Patients will receive standard pharmacotherapy(Acetaminophen 500mg QID, Etoricoxib 60mg with Thiocolchiside 4mg )along with lower back stretching exercises for 30 minutes daily.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Non-specific low back pain.
Pain has persistent at least 3 month.
Patient willing to participating in the study. 
 
ExclusionCriteria 
Details  1. History of spinal surgery
2. Specific causes of back pain (e.g., infection, tumor, fracture)
3. Neurological deficits (e.g., foot drop, severe sciatica)
4. Pregnancy or lactation
5. Known allergy to NSAIDs or muscle relaxants
6. Unable to participate in exercise therapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the NRS(Numeric Rating Scale)score between the groups.  1week,15days,4weeks,8weeks,12weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the disability using Hindi version of Roland-Morris disability questionnairs between the groups.
2.To compare the patient satisfaction score using 5 points Likerts scale between the grops. 		 1week,15days,4weeks,8weeks,12weeks 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This is a prospective randomized controlled trial designed to compare the efficacy of pharmacotherapy combined with hot fomentation versus pharmacotherapy combined with stretching exercises in patients with non-specific chronic low back pain .The aim is to assess improvement in pain intensity and functional status over a period of 12 weeks. Participants will be randomly allocated into two groups and evaluated using standard outcome measures such as the Numeric rating scale and Roland Morris Disability Questionnaire.   
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