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CTRI Number  CTRI/2024/04/065817 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Preventive
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Corticosteroid injection vs. Ultrasound therapy : Which works better for trigger finger?  
Scientific Title of Study   A comparative study of the efficacy of corticosteroid injection against ultrasound therapy in trigger finger. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arnab Halder 
Designation  Post graduate trainee 
Affiliation  Sambhu Nath Pandit hospital 
Address  Department of physical medicine and rehabilitation , Sambhu Nath Pandit hospital , 11 Lala Lajpat Rai Sarani , Kolkata , West Bengal-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9804254096  
Fax    
Email  itsarnab.2016@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jayanta Saha 
Designation  MBBS , MD PMR 
Affiliation  Sambhu Nath Pandit hospital 
Address  Department of physical medicine and rehabilitation , Sambhu Nath Pandit hospital , 11 Lala Lajpat Rai Sarani , Kolkata , West Bengal-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433094843  
Fax    
Email  djayantas@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Jayanta Saha 
Designation  MBBS , MD PMR 
Affiliation  Sambhu Nath Pandit hospital 
Address  Department of physical medicine and rehabilitation , Sambhu Nath Pandit hospital , 11 Lala Lajpat Rai Sarani , Kolkata , West Bengal-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433094843  
Fax    
Email  djayantas@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Arnab Halder 
Address  Department of physical medicine and rehabilitation , Sambhu Nath Pandit hospital , 11 Lala Lajpat Rai Sarani , Kolkata , West Bengal-700020 
Type of Sponsor  Other [Self] 
 
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 Jayanta Saha  Sambhu Nath Pandit Hospita  Department of Physical Medicine and Rehabilitation, 11 Lala Lajpat Rai Sarani,Kolkata, West Bengal-700020 Kolkata
Kolkata
WEST BENGAL 
9433094843

djayantas@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M653||Trigger finger,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound therapy   Patients will receive Therapeutic Ultrasound for 2 weeks followed by therapeutic exercise and a splint and analgesic as paracetamol (500mg) sos. Therapeutic Ultrasound will be as follows: Duration – 6 days/week for 2 weeks for 3 min treatment sessions (area over the maximum tenderness site and peripheral tissues of the nodule) each session. Intensity- 2 watt/cm2 , Frequency- 1 MHZ , Mode- continuous mode 
Intervention  Corticosteroid injection   Corticosteroid Injection : in a sterile environment Patients will receive injection of 1ml 40mg/ml Triamcinolone acetonide into the peritendinous soft tissues , deliberately avoiding the tendon. Followed by therapeutic exercise and a splint and analgesic as paracetamol 500mg sos.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Adult Trigger finger who had not responded to conservative treatment .
2)Recurrent trigger finger inspite of local steroid injection at least for two episodes.
 
 
ExclusionCriteria 
Details  1)Patient not fit for percutaneous release.
2)Bony deformities.
3)Diabetic Patients.
4)Local sepsis .
5)Immuno suppressed patient .
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of corticosteroid injection against ultrasound therapy in trigger digits . Splints and exercise were advised in both groups .   At baseline,2 weeks, 4 weeks ,6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare efficacy of corticosteroid injection against ultrasound therapy in trigger digits . Splints & exercise were advised in both groups .   At baseline,2 weeks, 4 weeks ,6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   26/04/2024 
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="0"
Months="8"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Trigger finger (TF), also known as stenosing tenovaginitis or tenosynovitis, is an hand disorder due to hypertrophy of the tendon sheath at the intersection of the tendon with its pulley; the subsequent constriction on the tendon prevents it from gliding through ligament’s pulley, causing a sudden release or locking of a finger during flexion or extension, pain and functional limitation.1
Pinching of the tendon can lead to nodule formation and patients typically present with a locking, popping sensation as the nodule catches at the constriction.2
In some cases, it resolves spontaneously; however, if left untreated, trigger digit may gradually progress until the affected finger is permanently locked in flexion.
Histologically, the A1 pulley exhibits fibrocartilaginous metaplasia, and in the tendon tissue, areas of hyalinosis, mucoid degeneration, and chondral metaplasia are found.
Trigger finger is usually classified as an idiopathic condition, but some other etiologic hypothesis was proposed. It has been postulated that this disorder is caused by high pressure at the proximal edge of the A1 pulley and the discrepancy between the diameter of the flexor tendon and its sheath at the metacarpal head.3 Some authors argue that there is a possible correlation with hand overuse and repetitive blunt trauma. Other potential risk factors include rheumatoid arthritis, diabetes mellitus, carpal tunnel syndrome, Dupuytren’s disease, amyloidosis, hypothyroidism, mucopolysaccharide storage disorders, congestive heart failure, and genetic predisposition. However; the main etiology is still unclear.
Trigger finger is the most common flexor tendinopathy, with highest incidence is between 52 and 62 years and in women (75%). Thumb and fourth digit (ring finger) are the most commonly affected fingers, the right hand is more frequently involved compared to the left hand and the dominant hand is more frequently involved compared to the non-dominant hand.
Diagnosis of Trigger finger is based on history of pain, morning stiffness, h/o triggering and tenderness on the A1 pulley, and on clinical examination. Treatment aims to eliminate pain and stop triggering.
Trigger finger’s therapy can be divided into conservative and surgical treatment. The currently accepted conservative treatments included medications, usually oral NSAIDS , ultrasound therapy and local corticosteroid injection (CI), with rehabilitative interventions, including extension splint, physiotherapy programs, with mobilization and stretching exercises and physical therapy. Surgical treatment involves percutaneous and open release of the A1 pulley, and it’s recommended only when Trigger finger has been unresponsive to conservative therapies. Corticosteroid injection and surgery are reported to be effective for the remission of symptoms. Corticosteroid injection have the greatest success rate among conservative treatments, but they are effective only for some patients, and could predispose to tendon rupture when repeated over time. Surgery is associated with longer recovery times and more complications including tendon bowstringing, digital ulnar drift, and nerve injuries. Recently, extracorporeal shock wave therapy (ESWT) is getting popular as an alternative to surgery for the treatment of musculoskeletal disorders in patients unresponsive to conservative approach. Extracorporeal shock wave therapy has been reported to be effective in several tendinopathies, such as calcific tendinopathies of the shoulder.4 lateral epicondylitis of the elbow, patellar tendinopathy, hamstrings tendinopathy and plantar fasciitis.5
A variety of treatments have been described in literature for Trigger finger, but the most effective treatment is still under debate.
 
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