Trigger Finger Clinical Trial
Official title:
Effectiveness of Cortisone Injection and Splinting for Trigger Finger: A Prospective Randomized Controlled Trial
Trigger finger has a prevalence rate of up to 3%. There are many approaches available to manage this condition. While corticosteroid injection is widely accepted as the most common first-line treatment, its superiority over splint treatment has not been established. This study aims to test the effectiveness of cortisone injections, splint and cortisone+splint to resolve symptoms.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Skeletally mature adults 2. Symptom duration of at least 3 months 3. Diagnosis of trigger finger: based on history of triggering and physical examination (pain over the flexor tendon, tenderness or nodule over the A1 pulley, stiffness, and reproducible locking or triggering). 4. Green's Grade 1-3 (Green's Classification to Grade the Severity of Trigger Finger) Exclusion Criteria: 1. Congenital trigger thumb 2. Green's Grade 4 (fixed flexion contracture) 3. Previous treatment for trigger finger (injection or surgery) 4. Allergy to cortisone 5. Multiple digits (>2 digits) |
Country | Name | City | State |
---|---|---|---|
Canada | Lawson Health Research Institute | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Castellanos J, Muñoz-Mahamud E, Domínguez E, Del Amo P, Izquierdo O, Fillat P. Long-term effectiveness of corticosteroid injections for trigger finger and thumb. J Hand Surg Am. 2015 Jan;40(1):121-6. doi: 10.1016/j.jhsa.2014.09.006. Epub 2014 Oct 14. — View Citation
Nimigan AS, Ross DC, Gan BS. Steroid injections in the management of trigger fingers. Am J Phys Med Rehabil. 2006 Jan;85(1):36-43. — View Citation
Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of symptoms | complete relief/partial relief/no relief | 6 week | |
Primary | Resolution of symptoms | complete relief/partial relief/no relief | 3 month | |
Primary | Resolution of symptoms | complete relief/partial relief/no relief | 6 month | |
Primary | Resolution of symptoms | complete relief/partial relief/no relief | 1 year | |
Secondary | Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 6 week | |
Secondary | Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 3 month | |
Secondary | Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 6 month | |
Secondary | Patients' experiences with the splint - Compliance | 1 poor 2 fair 3 good 4 very good 5 excellent | 1 year | |
Secondary | Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 6 week | |
Secondary | Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 3 month | |
Secondary | Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 6 month | |
Secondary | Patients' experiences with the splint - Comfort | 1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable | 1 year | |
Secondary | Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 6 week | |
Secondary | Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 3 month | |
Secondary | Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 6 month | |
Secondary | Patients' experiences with the splint - Ease of use | 1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use | 1 year | |
Secondary | Pain (Visual analogue scale) | on a scale ranging from "No pain" to "Pain as bad as it could possibly be") | 6 week | |
Secondary | Pain (Visual analogue scale) | on a scale ranging from "No pain" to "Pain as bad as it could possibly be") | 3 month | |
Secondary | Pain (Visual analogue scale) | on a scale ranging from "No pain" to "Pain as bad as it could possibly be") | 6 month | |
Secondary | Pain (Visual analogue scale) | on a scale ranging from "No pain" to "Pain as bad as it could possibly be") | 1 year | |
Secondary | Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 6 weeks | |
Secondary | Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 3 month | |
Secondary | Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 6 month | |
Secondary | Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts | Number of times | 1 year | |
Secondary | Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 6 week | |
Secondary | Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 3 month | |
Secondary | Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 6 month | |
Secondary | Incidence of Triggering: Severity (on Greens Grading Criteria) | Grade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture | 1 year | |
Secondary | Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 6 week | |
Secondary | Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 3 month | |
Secondary | Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 6 month | |
Secondary | Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire | on a scale of 0 (good) to 100 (poor) | 1 year | |
Secondary | Grip Strength (Affected hand) | Kilogram (Kg) | 6 week | |
Secondary | Grip Strength (Affected hand) | Kilogram (Kg) | 3 month | |
Secondary | Grip Strength (Affected hand) | Kilogram (Kg) | 6 month | |
Secondary | Grip Strength (Affected hand) | Kilogram (Kg) | 1 year | |
Secondary | Grip Strength (Un-affected hand) | Kilogram (Kg) | 6 weeks | |
Secondary | Grip Strength (Un-affected hand) | Kilogram (Kg) | 3 month | |
Secondary | Grip Strength (Un-affected hand) | Kilogram (Kg) | 6 month | |
Secondary | Grip Strength (Un-affected hand) | Kilogram (Kg) | 1 year | |
Secondary | Range of motion (Extensor lag) | degrees | 6 weeks | |
Secondary | Range of motion (Extensor lag) | degrees | 3 month | |
Secondary | Range of motion (Extensor lag) | degrees | 6 month | |
Secondary | Range of motion (Extensor lag) | degrees | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04094389 -
Comparison of Trigger Finger Orthotic Wearing Schedules
|
N/A | |
Completed |
NCT05435950 -
Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
|
N/A | |
Completed |
NCT04900220 -
Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections
|
Phase 4 | |
Completed |
NCT06401473 -
Using the Gate Control Theory of Pain to Decrease Pain During Trigger Finger Corticosteroid Injections
|
N/A | |
Completed |
NCT04354415 -
Tourniquet vs. No Tourniquet for Carpal Tunnel and Trigger Finger Release
|
N/A | |
Recruiting |
NCT06296017 -
Effectiveness of Conservative Interventions in the Treatment of Trigger Finger
|
N/A | |
Completed |
NCT06288685 -
Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone
|
Phase 3 | |
Completed |
NCT06382623 -
Efficacies of Different Managements in Patients With Trigger Finger
|
||
Active, not recruiting |
NCT04568993 -
The TriggerHappy Trial
|
N/A | |
Completed |
NCT04023695 -
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
|
Phase 4 | |
Recruiting |
NCT04645303 -
Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger
|
Early Phase 1 | |
Completed |
NCT01987115 -
Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers
|
N/A | |
Completed |
NCT02196233 -
Surgical Treatment of Adult Trigger Finger
|
||
Completed |
NCT01950793 -
A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger
|
N/A | |
Recruiting |
NCT04675892 -
Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers
|
N/A | |
Terminated |
NCT05082480 -
Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery
|
N/A | |
Recruiting |
NCT05045157 -
Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders
|
N/A | |
Active, not recruiting |
NCT01886157 -
Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting
|
N/A | |
Recruiting |
NCT00951236 -
Study Comparing One Versus Two Cortisone Injections for Trigger Finger
|
N/A | |
Withdrawn |
NCT04855942 -
Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger
|
N/A |