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CTRI Number  CTRI/2025/05/087473 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Sugar Water (Dextrose) and Steroid Injections for Knee Joint PainInjections for Pain and Function in Knee Osteoarthritis” 
Scientific Title of Study   Comparative Effects of Intra-articular Dextrose Prolotherapy and Intra-articular Triamcinolone Acetonide on Pain and Function in Knee Osteoarthritis: A Randomized Controlled Trial. 
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 Ravi Gaur 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Jodhpur 
Address  AIIMS Jodhpur Basni industrial area ,PMR department room no 15 Rajasthan, India
AIIMS JodhpAIIMS Jodhpur Basni industrial area ,PMR department room no 15 Rajasthan, Indiaur, Rajasthan India
Jodhpur
RAJASTHAN
342005
India 
Phone  9947332918  
Fax    
Email  ravisms80@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Gaur 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Jodhpur 
Address  AIIMS Jodhpur Basni industrial area ,PMR department room no 15 Rajasthan, India
AIIMS Jodhpur Basni industrial area ,PMR department room no 15 Rajasthan, India
Jodhpur
RAJASTHAN
342005
India 
Phone  9947332918  
Fax    
Email  ravisms80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Gaur 
Designation  Additional Professor 
Affiliation   
Address  AIIMS Jodhpur RajAIIMS Jodhpur Basni industrial area ,PMR department room no 15 Rajasthan, Indiaasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  9947332918  
Fax    
Email  ravisms80@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences AIIMS Jodhpur 
Address  All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan 
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 Ravi Gaur  AIIMS JODHPUR  PMR Department OPD ,1-5 AIIMS Jodhpur ,Rajasthan,342005
Jodhpur
RAJASTHAN 		 9947332918

ravisms80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intra-articular Dextrose Prolotherapy  Intervention: Name: Dextrose Prolotherapy Details: Group A will receive: Intra-articular injection of 5 ml 20% dextrose solution into the affected knee joint Frequency: Two sessions, 2 weeks apart Route: Intra-articular and perineural (ultrasound-guided) Concomitant therapy: All patients will undergo a standardized rehabilitation program comprising quadriceps strengthening, range of motion (ROM) exercises, gait training, and education on joint protection and activity modification. Adequate pain management provided. 
Intervention  Intra-articular Triamcinolone Acetonide  The comparator in this study is intra-articular triamcinolone acetonide, a corticosteroid drug administered in the form of an injection. Participants in this group will receive a single dose of 40 mg/mL triamcinolone acetonide injected directly into the affected knee joint. All participants will undergo a standardized rehabilitation program following the injection.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  78.00 Year(s)
Gender  Both 
Details  Adults aged 18 years or older

Radiologically confirmed knee osteoarthritis (Kellgren-Lawrence Grade II to IV)

Experiencing moderate to severe knee pain

Able to walk unassisted or with minimal assistance

Willing to participate in the study, receive injections, and attend follow-up visits 
 
ExclusionCriteria 
Details  Previous knee surgery within the past 6 months

Presence of inflammatory joint diseases (e.g., rheumatoid arthritis)

Active infection in or around the knee joint

Known allergy to dextrose or triamcinolone acetonide

Untreated blood clotting disorders

Pregnancy or breastfeeding 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the change in pain scores between the dextrose prolotherapy and triamcinolone acetonide groups in VAS score
2. To evaluate the changes in functional outcomes in WOMAC following dextrose prolotherapy compared to triamcinolone acetonide injections
 		 (Week 0), Week 4, Week 12, and Week 24 
 
Secondary Outcome  
Outcome  TimePoints 
I. To monitor and compare the incidence of adverse events between the dextrose prolotherapy and triamcinolone acetonide groups.
II. To assess quality of life in SF 36 scale outcomes following dextrose prolotherapy versus triamcinolone acetonide injections.
III. To evaluate the changes in Quadriceps hamstring ,tibilais muscles thickness measurement using ultrasound
IV. To evaluate the changes in Surface electromyography (sEMG) for muscle activation patterns during gait analysis
V. To evaluate the changes in Gait analysis using gait analysis system
VI. Assessing changes in femoral Cartilage thickness with ultrasound
 		 (Week 0), Week 4, Week 12, and Week 24 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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/ Phase 4 
Date of First Enrollment (India)   30/05/2025 
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="1"
Months="9"
Days="9" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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   This randomized controlled trial aims to compare the effectiveness of intra-articular dextrose prolotherapy versus intra-articular triamcinolone acetonide injection in patients with knee osteoarthritis. The study evaluates outcomes related to pain reduction, joint function, quality of life, and muscle parameters. The hypothesis is that dextrose prolotherapy provides longer-lasting pain relief and functional improvement compared to corticosteroid injections. A total of 112 participants will be randomly assigned to either intervention. Assessments will include Visual Analog Scale (VAS), WOMAC index, SF-36, ultrasound-based muscle thickness, and surface EMG analysis. Follow-up will be conducted over 6 months. 
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