| CTRI Number |
CTRI/2026/02/102979 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Interventional comparison study of effectiveness of dextrose and NS in rotatore cuff tendinopathy in shoulder pain |
|
Scientific Title of Study
|
A double blind comparison randomized control study to determine the efficacy of hypertonic dextrose prolotherapy in patients of supraspinatus tendinopathy in chronic shoulder pain in SMS Medical collage and hospital , jaipur , Rajasthan. |
| 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 Mrinal Joshi |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and Hospital |
| Address |
Room no 15 1st floor department of PMR RRC SMS Medical College and Hospital Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414057864 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrinal Joshi |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and Hospital |
| Address |
Room no 15 1st floor department of PMR RRC SMS Medical College and Hospital Jaipur
RAJASTHAN
302004
India |
| Phone |
9414057864 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul mudgal |
| Designation |
Junior resident |
| Affiliation |
Sms Medical College and Hospital |
| Address |
Department of PMR RRC SMS Medical College and Hospital Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7597836717 |
| Fax |
|
| Email |
Mudaliar.raj191@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PMR, RRC SMS medical collage and hospital Jaipur Rajasthan India
Pin 302004 |
|
|
Primary Sponsor
|
| Name |
Department of PMR, SMS medical college and hospital |
| Address |
Department of PMR RRC sms hospital and medical collage tonk road Jaipur rajasthan 302004 |
| 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 Rahul Mudgal |
SMS medical college and hospital |
Department of PMR RRC sms medical college and hospital jaipur
Jaipur
RAJASTHAN |
7597836717
mudgal.raj191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M679||Unspecified disorder of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection dextrose |
5 ml of 25% of dextrose solution given in supraspinatus insertion site and total duration of the intervention is 5 minutes. |
| Comparator Agent |
Injection NS |
Injection NS solution 5ml given in supraspinatus insertion site and total duration of this intervention is about 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
6 month history of shoulder pain
Usg diagnostic of supraspinatus tendinopathy |
|
| ExclusionCriteria |
| Details |
Experiencing pain comorbid with adhesive capsulitis and limited ROM
having received a steroid, PRP inj or any other injection in shoulder joint within 3 month
H/o receiving joint replacement or arthroscopy surgery on the affected shoulder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hypertonic dextrose prolotherapy and placebo in reducing pain and improving the ROM and functional capacity in patients with degenerative chronic supraspinatus tendinopathy in terms of VAS and SPADI scale. |
Outcome is assessed at baseline followed by follow up at 2 , 4 and 6 week after the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effect occurs after the intervention |
Assessed at the time of intervention & after the intervention up to 6 week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
In pain in shoulder is so much common problem in clinical practice and pain in the shoulder may be due to rotator cuff and specially due to supraspinatus tendinopathy. So in this study our aim is to find the efficacy of hypertonic dextrose solution and normal saline solution in improving pain ROM and functional status of shoulder affected by chronic supraspinatus tendinopathy. |