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CTRI Number  CTRI/2024/08/072131 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study compares two treatment methods for improving pain and function in patients with de Quervain’s tenosynovitis 
Scientific Title of Study   Effectiveness of platelet rich plasma in comparison with Triamcinolone Hexacetonide in improving pain and function in patients with de Quervains tenosynovitis: A Randomised 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  WUPPI MIKU 
Designation  Post graduate trainee 
Affiliation  Department of Physical Medicine and Rehabilitation Regional Institute of medical sciences 
Address  Department of Physical Medicine and Rehabilitation Regional Institute of medical sciences Manipur India

Imphal West
MANIPUR
795001
India 
Phone  9402202314  
Fax    
Email  Woopimiku@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  NAOREM BIMOL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Regional institute of medical sciences 
Address  Department of Physical Medicine and Rehabilitation, RIMS Manipur India

Imphal West
MANIPUR
795004
India 
Phone  7005291542  
Fax    
Email  bimoldr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  NAOREM BIMOL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Regional institute of medical sciences 
Address  Department of physical medicine and rehabilitation , RIMS Manipur, Imphal west India

Imphal West
MANIPUR
795004
India 
Phone  7005291542  
Fax    
Email  bimoldr@yahoo.com  
 
Source of Monetary or Material Support  
Regional Institute of Medical Sciences (RIMS) Imphal west Manipur India 795004  
 
Primary Sponsor  
Name  Regional institute of medical sciences 
Address  Rims Imphal west manipur, 795004 
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 WUPPI MIKU  Regional Institute of Medical Sciences  Department of Physical Medicine and Rehabilitation Regional Institute of Medical sciences Imphal West Pin code: 795004
Imphal West
MANIPUR 		 9402202314

woopimiku@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M654||Radial styloid tenosynovitis [de Quervain],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  triamcinolone hexacetonide   Patient is placed supine position, arms fully adducted at the patient’s side with the ulnar surface of wrist and hand resting on a folded towel to relax affected tendons. After sterile preparation of skin, under ultrasound guidance tendons are identified and 2ml triamcinolone hexacetonide is injected vertically with radial styloid process as landmark.At the end of each procedure patient will be followed up for 1,4,12,24 weeks.  
Intervention  Ultrasound guided platelet rich plasma injection  PRP will be prepared using Double spin method: Whole blood is to be obtained in a 20ml syringe by venipuncture which is then transferred to an acid citrate dextrose tube. Centrifugation of these tubes will be done using a ‘soft’ spin at 2400 rpm for 10 minutes. The supernatant plasma containing platelets will be collected in a separate plasma containing platelets will be centrifuged again at hard spin i.e., 3600 rpm for 15 minutes to obtain a platelet concentrate. The lower 1/3rd is PRP and upper 2/3rd is platelet- poor plasma (PPP). 4ml of PRP will be procured by removing the PPP. Patient is placed supine position, arms fully adducted at the patient’s side with the ulnar surface of wrist and hand resting on a folded towel to relax affected tendons. After sterile preparation of skin, under ultrasound guidance tendons are identified and 2ml of platelet rich plasma is injected vertically with radial styloid process as landmark. At the end of each procedure patient will be followed up for 1,4,12,24 weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
1.Age between 20-60 years of both genders
2.Duration of symptoms less than 6 weeks
3.Visual analogue scale (VAS) ≥ 4
4.Patients willing for study and follow up assessments.
 
 
ExclusionCriteria 
Details  1. Patients with uncontrolled diabetes
2. Congenital deformity of hand
3. Rheumatoid arthritis
4. Pregnancy
5. Local infection
6. Thrombocytopenia
7. Impaired cognition

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale (VAS)
 
1,4,12,24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Quick DASH  1,4,12,24 weeks 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 2 
Date of First Enrollment (India)   20/08/2024 
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="10" 
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   This study is a randomised parallel group active controlled trial comparing ultrasound guided platelet rich plasma injection with Triamcinolone hexacetonide in improving pain and function in patients with de quervain tenosynovitis. Among 52 patients that will be conducted in Dept. of PMR RIMS, Imphal. The outcome measures for the study will be Visual analogue scale and Quick DASH measured at baseline and 1,4,12,24 weeks post intervention. 
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