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CTRI Number  CTRI/2023/11/059972 [Registered on: 17/11/2023] Trial Registered Prospectively
Last Modified On: 17/01/2026
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   Comparing two drugs around nerves in patients with long term muscle pain. 
Scientific Title of Study   A Double blinded Randomized controlled trial comparing the effectiveness of Perineural prolotherapy versus local anesthetic injections of Spinal Accessory Nerve and Dorsal Scapular Nerve in Chronic Myofascial Pain Syndrome 
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 Nitesh Manohar Gonnade 
Designation  Additional Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No 6 PMR OPD ground floor AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9530199967  
Fax    
Email  drniteshgonnade9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitesh Manohar Gonnade 
Designation  Additional Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No. 6 PMR OPD ground floor AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9530199967  
Fax    
Email  drniteshgonnade9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nitesh Manohar Gonnade 
Designation  additional professor 
Affiliation  AIIMS Jodhpur 
Address  Room No. 6 PMR OPD ground floor AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9530199967  
Fax    
Email  drniteshgonnade9@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES [AIIMS], JODHPUR 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
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 Parthkumar  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, AIIMS Jodhpur   PMR OPD ground floor, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 8347975058

parthtrivedi8347@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Perineural Lignocaine  Injecting 1O mL 1% Lignocaine Perineurally to both nerves as two injections one month apart. 
Intervention  Perineural Prolotherapy  Injecting 1O mL 5% Dextrose Perineurally to both nerves as two injections one month apart. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosis of MFPS in the upper trapezius muscle in accordance with Simons and Travell’s essential criteria.
No treatment, including injection, dry needling, and physical modalities, in the past 3 months.
No h/o intake of NSAIDS in the past 7 days before injection.
VAS > 5
 
 
ExclusionCriteria 
Details  Bleeding tendency
History of neck and shoulder trauma
History of other disease affecting neck and shoulder pain, such as fibromyalgia, cervical radiculopathy, or adhesive capsulitis
Allergy to lignocaine
Uncontrolled diabetes mellitus
Infection at injection site
Patient refuse to participate
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain improvement using VAS-10  At baseline and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life using SF-12  At baseline & 3 months. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   Phase 3 
Date of First Enrollment (India)   27/11/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Chronic myofascial pain syndrome is common cause of upper back pain and significantly affect patients’ quality of life. There are studies targeting various nerves for the management of MFPS via various treatment modalities such as- plain local anesthetic injections, steroid injections and prolotherapy. The nerves I am targeting in my study- Spinal Accessory Nerve and Dorsal Scapular Nerve, are not studied extensively and there is a lacuna in research for these two nerves supplying Trapezius and Rhomboids muscle groups. With the help of my study, I aim to establish the effectiveness of perineural prolotherapy of these two nerves in the treatment of MFPS.  
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