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CTRI Number  CTRI/2025/02/081465 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effectiveness of perineural corticosteroid injection and perineural dextrose prolotherapy for treating occipital neuralgia in patients in a Central Indian tertiary care hospital: A , parallel arm, randomised, non-inferior trial  
Scientific Title of Study   Comparison of efficacy of perineural dextrose prolotherapy with perineural corticosteroid injection in the treatment of patients with occipital neuralgia in a tertiary care hospital in the Central India: A non-inferior, randomised, assessor blind, parallel arm study 
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 Sonali Sahani  
Designation  Junior Resident, Department of Physical Medicine and Rehabilitation  
Affiliation  AIIMS, Nagpur 
Address  OPD 111, first floor, OPD complex, Department of Physical Medicine and Rehabilitation, AIIMS Nagpur, Plot no 2, sector 20, Mihan Nagpur.

Nagpur
MAHARASHTRA
441108
India 
Phone  9140495305  
Fax    
Email  sonalisahani24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harshanand Popalwar 
Designation  Associate Professor, Department of Physical Medicine and Rehabilitation  
Affiliation  AIIMS, Nagpur 
Address  OPD 111, first floor, OPD complex, Department of Physical Medicine and Rehabilitation, AIIMS Nagpur, Plot no 2, sector 20, Mihan Nagpur.

Nagpur
MAHARASHTRA
441108
India 
Phone  9424917696  
Fax    
Email  harshanand.popalwar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Sahani  
Designation  Junior Resident, Department of Physical Medicine and Rehabilitation  
Affiliation  AIIMS, Nagpur 
Address  OPD 111, first floor, OPD complex, Department of Physical Medicine and Rehabilitation, AIIMS Nagpur, Plot no 2, sector 20, Mihan Nagpur.

Nagpur
MAHARASHTRA
441108
India 
Phone  9140495305  
Fax    
Email  sonalisahani24@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur.PINCODE:441108  
ICMR, DHR PG Thesis grant, Department of Health Research 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi-110029 
Type of Sponsor  Research institution 
 
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 Sonali Sahani  All India Institute of Medical Sciences, Nagpur, Mihan, Nagpur, Pincode 441108  OPD 111, first floor, Department of Physical Medicine and Rehabilitation,AIIMS Nagpur
Nagpur
MAHARASHTRA 		 9140495305

sonalisahani24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Perineural dextrose prolotherapy   patients with occipital neuralgia will be given perineural injection of 1 ml 5% dextrose and 1 ml 2% lignocaine around Greater, lesser and/or third occipital nerve  
Comparator Agent  Perineural triamcinolone injection   patients with occipital neuralgia will be given perineural injection of 1ml 20 mg triamcinolone and 1 ml 2% lignocaine around Greater, lesser and/or third occipital nerve 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Diagnose case of occipital neuralgia according to ICHD 3 criteria
A Unilateral or bilateral pain fulfilling criteria B to E
B Pain is located in the distribution of the greater, lesser, and/or third occipital nerves
C Pain has two of the following three characteristics
1 Recurring in paroxysmal attacks lasting from a few seconds to minutes
2 Severe intensity
3 Shooting, stabbing, or sharp in quality
D Pain is associated with both of the following
1 Dysaesthesia and/or allodynia apparent during innocuous stimulation of the scalp and/or hair
2 Either or both of the following
a Tenderness over the affected nerve branches
b Trigger points at the emergence of the greater occipital nerve or in the area of distribution
of C2
E Pain is eased temporarily by local anesthetic block of the affected nerve
F Not better accounted for by another ICHD 3 diagnosis 
 
ExclusionCriteria 
Details  1 Pregnant females
2 Patients below the age of 18 and above 75
3 Patient with uncontrolled diabetes mellitus
4 Patient on analgesic medication for condition other than occipital neuralgia
5 Patients with neuralgia due to tumor, acute infection and/or trauma 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
pain reduction via VAS score and Barrow Neurological Pain Scale   1) pre procedure
2) 2 weeks post procedure
3) 4 weeks post procedure
4) 8 weeks post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in quality of life as measure by SF-12 scale  1) pre procedure
2) 2 weeks post procedure
3) 4 weeks post procedure
4) 8 weeks post procedure 
ii) To study the efficacy of perineural dextrose prolotherapy and perineural steroid injection in the treatment of patient with occipital neuralgia  1) pre procedure
2) 2 weeks post procedure
3) 4 weeks post procedure
4) 8 weeks post procedure 
To study the dermatomal distribution of occipital neuralgia in Greater Occipital Nerve, Lesser occipital Nerve and third occipital Nerve   
Document characteristic of background pain (quality, location, and intensity) and pain exacerbations (frequency, duration, quality) in occipital neuralgia   
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   09/02/2026 
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)   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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonalisahani24@gmail.com].

  6. For how long will this data be available start date provided 16-12-2028 and end date provided 16-12-2033?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

According to International Classification of Headache Disorder, Occipital Neuralgia is described as Unilateral or bilateral paroxysmal, shooting or stabbing pain in the posterior part of the scalp, in the distribution(s) of the greater, lesser and/or third occipital nerves, sometimes accompanied by diminished sensation or dysesthesia in the affected area and commonly associated with tenderness over the involved nerve(s).

Occipital neuralgia typically affects the greater occipital nerve (GON) primarily, followed by the lesser occipital nerve (LON) and the third occipital nerve (TON). Currently, primary treatment for occipital neuralgia is an Occipital Nerve block with a local anaesthetic with or without corticosteroid that serve as a both diagnostic and therapeutic modality. While expert consensus supports the utilization of corticosteroids for peripheral nerve blocks, there are notable constraints to its application. For instance, it’s contraindicated in pregnancy and for patients with cosmetic concerns due to potential side effects like alopecia and cutaneous atrophy. As an alternative, we propose to study and compare the effect of perineural dextrose prolotherapy of GON/LON/TON as an alternative treatment for occipital neuralgia versus perineural steroid injection of GON/LON/TON on pain reduction and quality of life.

Yung-Tsan Wu, MD et al. compared the effects of corticosteroid and perineural injections of 5% dextrose around the median nerve in patients with carpal tunnel syndrome. The results showed that, at 4 to 6 months after injection, perineural injections of 5% dextrose were more beneficial than corticosteroid in patients with mild-to-moderate CTS, with a mean reduction of 4.3 VAS score in the dextrose arm and 1.7 in the steroid arm. This study aims to provide a comparison between perineural dextrose prolotherapy with perineural corticosteroid injection for treatment of occipital neuralgia.

 
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