Clinical trial NCT04002037: Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
Official title: Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Trigger Finger
Keywords: Trigger Finger
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Injection of corticosteroid into the area immediately surrounding the A1 pulley and flexor tendon
2. Surgical release of the A1 pulley

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), QuickDASH (Disabilities of the Arm, Shoulder and Hand) and PROMIS Upper Extremity scores, VAS.

Inclusion/Exclusion:

Inclusion criteria:

1. Adults aged 18 years and older
2. At least one symptomatic trigger finger
3. Patients recommended to receive corticosteroid injections

Exclusion criteria:

1. Previous surgeries/injections for trigger fingers in digit being treated for study
2. Participating in another clinical trial
3. Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
4. Unable to sign informed consent
5. Pregnant or plan to become pregnant

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 QuickDASH surveys to collect data at baseline.

Enrolled patients will be randomized to one of three treatment arms:

1. Triamcinolone 40mg/mL
2. Triamcinolone 10mg/mL
3. Soluble dexamethasone 4mg/mL

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:

* QuickDASH
* PROMIS scores
* VAS Second Corticosteroid injection (if subject still symptomatic)

  12 Week (3 Month) Follow-Up (if applicable):

Objective Measures:

- Grade of triggering (Green classification of trigger finger severity1)

Subjective Measures:

- QuickDASH

- 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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 years and older
2. At least one symptomatic trigger finger
3. Patients recommended to receive corticosteroid injections

Exclusion Criteria:

1. Previous surgeries/injections for trigger fingers in digit being treated for study
2. Participating in another clinical trial
3. Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
4. Unable to sign informed consent
5. Pregnant or plan to become pregnant

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 6 Weeks
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 12 Weeks
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 6 Month
measure: Pain Visual Analog Score (VAS)
timeFrame: 6 Weeks
measure: Pain Visual Analog Score (VAS)
timeFrame: 12 Weeks
measure: Pain Visual Analog Score (VAS)
timeFrame: 6 Month
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
timeFrame: 6 Weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
timeFrame: 12 Weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
timeFrame: 6 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Daniel London, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.