FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080004 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of steroid injection versus dextrose injection, also known as prolotherapy in patients with carpal tunnel syndrome. 
Scientific Title of Study   Efficacy of single dose of perineural prolotherapy and corticosteroid injections in primary Carpal Tunnel Syndrome at a tertiary care hospital in India - A randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC/AIIMS BBSR/PG Thesis/2024-25/03   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshmi Sajith 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Physical Medicine and Rehabilitation AIIMS Bhubaneswar Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  8073930152  
Fax    
Email  lakshmi6896@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Apurba Barman 
Designation  Additional Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Physical Medicine and Rehabilitation AIIMS Bhubaneswar Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9438884211  
Fax    
Email  pmr_apurba@aiimsbhubaneswar.edu.in   
 
Details of Contact Person
Public Query  
Name  Dr Apurba Barman 
Designation  Additional Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Physical Medicine and Rehabilitation AIIMS Bhubaneswar Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9438884211  
Fax    
Email  pmr_apurba@aiimsbhubaneswar.edu.in   
 
Source of Monetary or Material Support  
AIIMS BHUBANESWAR Odisha PO Dumuduma Dist Khurda PIN 751019  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar Odisha 
Address  AIIMS BHUBANESWAR ODISHA SIJUA PATRAPADA PO Dumduduma Dist Khurda PIN 751019 
Type of Sponsor  Government medical college 
 
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 LAKSHMI SAJITH  AIIMS  ROOM NO 5 DEPARTMENT OF PMR AIIMS BHUBANESWAR
Khordha
ORISSA 		 8073930152

lakshmi6896@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CORTICOSTEROID INJECTION  Group B- Patients will receive a single dose of 40mg corticosteroid injection (1ml) and 4 ml Lignocaine perineurally 
Intervention  DEXTROSE PROLOTHERAPY,  Group A- Patients will receive a single dose of (5%) dextrose prolotherapy injection (5ml) perineurally 
Intervention  NORMAL SALINE (PLACEBO)  Group C- Control group- Patients will receive a single dose of perineural Normal Saline (0.9%) injection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients aged above 18 years
2.Patients with Nocturnal paresthesia, symptomatically getting relief after shaking the hands.
3.Pain, paresthesia or sensory symptoms in the area of the median nerve over the thumb and finger.
4.Symptoms longer than 4 weeks duration.
5.Numbness in sensory distribution of median nerve.
6.Weakness with atrophic change of median nerve innervated thenar muscles.
7.Phalen test +, and or Tinel Sign +. 
 
ExclusionCriteria 
Details  1.Pregnancy
2.H/O of polyneuropathy, brachial plexopathy, thoracic outlet syndrome.
3.H/O Inflammatory arthritis, Type 2 DM, Rheumatologic disorder.
4.Previous h/o CS Injection, Skin infection on injection site, trauma or neoplasm at injection site, hypersensitivity to corticosteroid.
5.Current warfarin use. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.To measure pain relief following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.  1. 0 weeks (V0)
2. 6 weeks (V1)
3. 12 weeks (V2) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To measure functional improvement following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.  2 years 
To measure the change in quality of life following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.  2 years 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   15/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

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

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 28-01-2025 and end date provided 28-01-2027?
    Response - Immediately following publication. No end date.

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

We aim to investigate the effectiveness of dextrose prolotherapy compared to corticosteroid injection in reducing pain and improving function in patients with Carpal Tunnel Syndrome. We hypothesize that dextrose prolotherapy injection will be superior to corticosteroid injection in terms of pain relief and functional improvement. This study has the potential to provide valuable insights into the use of regenerative injections in Carpal Tunnel Syndrome management and contribute to better outcomes for patients.

 
Close