Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04002037 |
|
Recruitment Status :
Recruiting
First Posted : June 28, 2019
Last Update Posted : October 30, 2020
|
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 21, 2019 | ||||||||
| First Posted Date ICMJE | June 28, 2019 | ||||||||
| Last Update Posted Date | October 30, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 25, 2019 | ||||||||
| Estimated Primary Completion Date | June 15, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE |
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis | ||||||||
| Official Title ICMJE | Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial | ||||||||
| Brief Summary | Trigger finger is a common cause of hand pain and dysfunction. Its due to chronic inflammation of the flexor tendon that leads to a pulley system mismatch. Historically it has been managed either conservatively with corticosteroid injections or through a surgical release of the A1 pulley. Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. The purpose of out study is to determine if a 0.5 cc injection of Triamcinolone 40 mg/mL will be the most effective steroid injection for the non-surgical treatment. Approximately 200 subjects will be enrolled and randomized to one of three treatment arms: Triamcinolone 40mg/mL, Triamcinolone 10mg/mL and Soluble dexamethasone 4mg/mL. Treatment success will be defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months). | ||||||||
| Detailed Description | Idiopathic stenosing tenosynovitis of the digits, more commonly known as "trigger finger", is a common cause of hand pain and dysfunction. Many previous studies have described the pathophysiology of this condition and it can be summarized as inflammation of the flexor tendons leading to a size mismatch between the tendon and the flexor pulley system. By far the most common location of this mismatch is at the A1 pulley. The current mainstay of treatment has been:
Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. Less commonly used treatment strategies have included: topical NSAIDs and extracorporeal shock therapy. The typical progression of treatment is one or two steroid injections and then surgical release if injections have failed. To our knowledge, there have been no head to head comparison studies of the efficacy of different corticosteroid formulations in preventing conversion to surgical treatment. In our study, the investigators will look at the efficacy of two of the most commonly used steroids: triamcinolone and dexamethasone. Objectives: Primary outcome: Treatment success, defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months). Secondary outcomes: Grade of triggering (Green classification of trigger finger severity1), DASH (Disabilities of the Arm, Shoulder and Hand) and PROMIS Upper Extremity scores, VAS. Inclusion/Exclusion: Inclusion criteria:
Exclusion criteria:
Study Procedures/Methods: Enrollment/Randomization/Treatment Visit: Eligible patients presenting with primary flexor tenosynovitis will be enrolled on a voluntary basis. Prior to the injection, subjects will be asked to complete the PROMIS and DASH surveys to collect data at baseline. Enrolled patients will be randomized to one of three treatment arms:
Each study patient will receive the appropriate corticosteroid injection in the affected digit(s), consisting of a 1:1 mixture of 1% lidocaine plain and corticosteroid, total volume 1cc. Blinding: Syringes will be prepared and masked with opaque tape by the clinic nurses, thus providing blinding for providers administering the injection. Follow-Up/Clinic Visits: Subjects will be re-evaluated at 6 weeks post-injection and, if still symptomatic, will undergo a second injection of the same corticosteroid solution. At final follow-up (12 weeks), symptomatic patients who have failed treatment after 2 injections will be offered surgical release of the A1 pulley. Subjects who refuse a second injection at 6 weeks follow-up will be offered surgery, and the reason for refusal (treatment failure) will be recorded. The visits and all research activity will be outlined below: 6 Week Follow-Up: Objective Measures: - Grade of triggering (Green classification of trigger finger severity1) Subjective Measures:
Objective Measures: - Grade of triggering (Green classification of trigger finger severity1) Subjective Measures: - DASH - PROMIS scores - VAS 6 Month Follow-Up: The patient will be contacted to check on the status of their condition. If they are still experiencing a degree of triggering they will be advised by their physician to return to clinic for a standard of care visit. If they are no longer experiencing triggering, they will be asked to complete a survey over the phone or online only. Specimen Collection: If a patient is recommended to undergo surgery at the end of the study, the tenosynovium that is normally resected and discarded after surgery will be collected for analysis. After collection these tissues and data will be identified from the patient and assigned a number for use in study analysis. The investigators seek to only collect tissues from patients that are normally removed and discarded during trigger finger release procedures. None of the patients will undergo additional surgical procedures for the collection of tissues in this study. For simplification purposes, potential subjects must agree to the collection of these specimens to participate in the study, even if they do not end up needing surgical intervention. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Trigger Finger | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | 1- Wolfe SW, Hotchkiss RN, Pederson WC, Kozin SH, Tendinopathy, in: Green's Operative Hand Surgery, 6th edition, Churchill Livingstone, Chap. 62, p. 5, 2011. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 15, 2025 | ||||||||
| Estimated Primary Completion Date | June 15, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04002037 | ||||||||
| Other Study ID Numbers ICMJE | 2014036 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Sebastien Lalonde, University of Missouri-Columbia | ||||||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | University of Missouri-Columbia | ||||||||
| Verification Date | October 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||