| 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
|
|
|
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
|
|
|
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
|
|
|
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. |