| CTRI Number |
CTRI/2026/01/100577 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Trial Comparing Effectiveness of Dextrose Prolotherapy Versus Corticosteroids for Managing Pain in Moderate Knee Osteoarthritis |
|
Scientific Title of Study
|
Comparative Efficacy of Dextrose Prolotherapy and Intra Articular Corticosteroids in Grade II 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 |
Premi Sapam |
| Designation |
Post graduate trainee |
| Affiliation |
NRS Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,Nil Ratan Sircar Medical College and Hospital,138 AJC Bose Road Kolkata.
Kolkata
WEST BENGAL
700014
India |
| Phone |
7005842614 |
| Fax |
|
| Email |
imerpmapas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Partha Pratim Das |
| Designation |
Professor |
| Affiliation |
NRS Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,Nil Ratan Sircar Medical College and Hospital,138 AJC Bose Road Kolkata.
Kolkata
WEST BENGAL
700014
India |
| Phone |
9433943719 |
| Fax |
|
| Email |
drppdaspmr74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Partha Pratim Das |
| Designation |
Professor |
| Affiliation |
NRS Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,Nil Ratan Sircar Medical College and Hospital,138 AJC Bose Road Kolkata.
Kolkata
WEST BENGAL
700014
India |
| Phone |
9433943719 |
| Fax |
|
| Email |
drppdaspmr74@gmail.com |
|
|
Source of Monetary or Material Support
|
| NRS Medical College and Hospital 138 AJC BOSE road Sealdah, Kolkata 700014 West Bengal India |
|
|
Primary Sponsor
|
| Name |
Nil Ratan Sircar Medical College and Hospital Kolkata |
| Address |
Nil Ratan Sircar Medical College and Hospital 138 AJC Bose Road Kolkata 700014 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Partha Pratim Das |
NRS Medical College Kolkata |
Department of Physical Medicine and Rehabilitation,Elliot Building Ground floor 138 AJC Bose Road Kolkata 700014
Kolkata
WEST BENGAL |
9433943719
drppdaspmr74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nil Ratan Sircar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dextrose Prolotherapy |
Participants will be positioned supine with the target knee flexed 10–15° and prepared under strict aseptic precautions using povidone-iodine and alcohol.Ultrasound probe will be placed longitudinally over the superior border of the patella to identify the suprapatellar recess. Sterile draping and a covered ultrasound probe with coupling gel will be used throughout the procedure. Using an in-plane lateral-to-medial approach, a 1.5-inch 25-gauge needle will be advanced under real-time ultrasound guidance, with aspiration of synovial fluid when present. Then 5 ml of 25% dextrose will be administered slowly under direct visualization.Total duration 18 months |
| Comparator Agent |
Intra Articular Corticosteroids |
Participants will be positioned supine with the target knee flexed 10–15° and prepared under strict aseptic precautions using povidone-iodine and alcohol.Ultrasound probe will be placed longitudinally over the superior border of the patella to identify the suprapatellar recess. Sterile draping and a covered ultrasound probe with coupling gel will be used throughout the procedure. Using an in-plane lateral-to-medial approach, a 1.5-inch 25-gauge needle will be advanced under real-time ultrasound guidance, with aspiration of synovial fluid when present. Then 1ml of triamcinolone acetate mixed with 4 ml of normal saline will be administered slowly under direct visualization.Total duration 18 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with primary knee osteoarthritis fulfulling ACR criteria.
2.Radiologically confirmed Kellgren Lawrence Grade II knee Osteoarthritis.
3.VAS pain score more than or equal to 6 in past 2 weeks.
4.Willing and able to provide informed consent and comply with study follow up. |
|
| ExclusionCriteria |
| Details |
1.Intra-articular injection in any joint within the past 6 months.
2.Use of NSAIDs, analgesics, or slow-acting OA drugs within the restricted time frame.
3.History of knee surgery or arthroscopic procedure in the last 1 year.
4.Secondary or inflammatory arthritis, generalized OA, or coexisting hip/foot OA or back pain.
5.Ligament or meniscal injury, tense effusion, or cutaneous lesions over the knee.
6.BMI more than 35
7.Haemoglobin less than 10 g/dL.
8.Bleeding disorders, or anticoagulant therapy.
9.Presence of active infection, immunosuppression, neoplasm, or systemic illness (e.g., uncontrolled diabetes, thyroid disease).
10.Presence of nociplastic pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain reduction measured by Visual Analogue Scale (VAS) |
Baeline
4 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional outcome assessed by KOOS (Knee injury and Osteoarthritis Outcome Score).
Duration of effect.
Adverse events,if any.
|
Baseline
4 weeks
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 4 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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)
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 single blind two arm clinical trial aims to compare the effectiveness of dextrose prolotherapy and intra articular corticosteroid injection in patients with grade II knee osteoarthritis. A total of 126 adults aged 40 to 80 years with at least 6 months of knee pain not responding to conservative treatment will be enrolled and randomized equally into two groups. All procedures will be performed under ultrasound guidance using standard drug protocols. The primary objective is to assess pain reduction using Visual Analogue Scale, secondary objectives include assessment of functional improvement using the Knee Injury and Osteoarthritis Outcome Score, duration of relief and adverse effects. Follow up assessment will be conducted at 4 and 12 weeks. Patients with recent trauma or surgery, Intra-articular injection in the past 6 months, secondary OA or inflammatory arthritis, bleeding disorders or anticoagulant therapy, active infection or systemic illness will be excluded. Data will be analyzed using appropriate parametric and non parametric tests. The study is expected to identify whether dextrose prolotherapy provides superior clinical improvement compared to corticosteroid injection in early knee osteoarthritis |