| CTRI Number |
CTRI/2018/07/014764 [Registered on: 09/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Other (Specify) [Ultrasound guided injection] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of wrist pain due to repeated movements of the thumb. |
|
Scientific Title of Study
|
To compare the effectiveness of Ultrasound-guided infiltration of steroids vs surgical release in de Quervains tenosynovitis |
| Trial Acronym |
USG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Mathew |
| Designation |
PG resident, Department of Orthopaedics |
| Affiliation |
Father Muller Medical College and Hospital |
| Address |
Department of Orthopaedics
Father Muller Medical College and Hospital,
Kankanady,
Mangalore 575001
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8310454177 |
| Fax |
|
| Email |
ash.9mathew@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Latheesh Leo |
| Designation |
Unit Chief, Hand and Micro surgery |
| Affiliation |
Father muller medical college and hospital |
| Address |
Department of Orthopaedics
Father Muller Medical College and Hospital,
Kankanady,
Mangalore 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8277466976 |
| Fax |
|
| Email |
latheeshlatheesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Mathew |
| Designation |
Orthopedics Resident |
| Affiliation |
Father muller medical college and hospital |
| Address |
Department of Orthopaedics
Father Muller Medical College and Hospital,
Kankanady,
Mangalore 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8310454177 |
| Fax |
|
| Email |
ash.9mathew@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,
Father Muller Medical College and Hospital,
Kankanady, Mangalore
Karnatake India 575001 |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College and Hospital |
| Address |
Kankanady,
Mangalore
Karnatake India 575001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ashish Mathew |
Father Muller Medical College and Hospital Kankanady, Mangalore |
Department of Orthopaedics,Father Muller Medical College and Hospital
Kankanady, Mangalore Karnatake India 575001
Dakshina Kannada
KARNATAKA |
8310454177
ash.9mathew@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients who have been diagnosed to have de Quervains tenosynovitis, (1) ICD-10 Condition: M654||Radial styloid tenosynovitis [de Quervain], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound guided corticosteroid injection( Triamcinolone injection)., |
Triamcinolone injection 1 ml dose 20mg was taken and under ultrasound guidance the 1st extensor compartment of the involved wrist was visualised and the tendon sheath was infiltrated with the steroid under aseptic precautions. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
cases with a documented history of pain over the radial aspect of the wrist, aggravated by excessive use of the thumb,
a documented physician’s diagnosis of de Quervain’s tenosynovitis,
and a documented positive Finkelstein’s test in the patient’s medical record. |
|
| ExclusionCriteria |
| Details |
minor age (< 18),
presence of a separate compartment for EPB presence of an absolute contraindication for corticosteroid injection,
prior treatment in the last six months with steroid injection and/or surgery at the same anatomical location,
and possible traumatic or neoplastic origin of symptoms. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptomatic relief that was calculated based on DASH score( Disability of Arm, Shoulder and Hand)post procedure. |
DASH scores that were calculated after 2 weeks ,2 months and 6 months post the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Delay the need for surgery |
2 years |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2017 |
| Date of Study Completion (India) |
01/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/08/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: de Quervain’s tenosynovitis is a stenosing tenosynovitis of the first extensor compartment of the wrist and leads to wrist pain along with impaired function of the wrist and hand. Local steroid injection and surgical release forms the mainstay treatment in the conservative and surgical line of treatment respectively till date. This study aims to bring out the effectiveness of local steroid injection given accurately under ultrasound guidance making it comparable to surgical release in the short term period , thereby emerging as an immediate and cost – effective line of management. MATERIAL & METHODS: Twenty three patients diagnosed with de Quervain’s tenosynovitis were included in this study whom did not show any relief of symptoms when conservative mode was used namely rest and analgesics and splinting in certain cases. Clinically patients were assessed using DASH score based on the severity of condition before the procedure and after the procedure. A mixture of 1 ml of triamciniolone and 1 ml of 1% lidocaine hydrochloride was taken under aseptic precautions and was injected into the involved compartment under expert guidance with help of ultrasound imaging. Clinical improvement was later evaluated by analyzing the pre procedural and post procedural DASH (Disabilities of the Arm, the Shoulder and the Hand) score indexes comparing it to surgical release.8 RESULTS: 22 patients (96% were symptom-free) out of the 23 patients that were included, after the 1st injection at two weeks. At the end 6 months 22 (96%) patients were symptom free and were fully satisfied with the gratifying outcome. No recurrence in these patients after a 1 year of follow-up was recorded. The one failed patient underwent surgery for release of the first extensor compartment and was symptom-free at the 2 weeks post –op after assessment. Adverse reaction of the steroids were incidentally seen in 2/23 (16%) of the patients, which eventually subsided in 20 weeks. Incidence of nerve injury, infection, or tendon rupture did not occur. CONCLUSION: We draw to close that selective infiltration of steroids in the common sheath of the EPB and APL under Ultrasound -guidance provides an evocative improvement of pain and function in greater number of patients with de Quervain’s Syndrome thereby avoiding a possible surgery. Keyword: Ultrasound guided, infiltration, DASH |