Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis

NCT04002037 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2014039
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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).

Conditions

Trigger Finger

Keywords

Trigger Finger

Outcome Measures

Primary Outcomes (9)

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.

  6 Weeks

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.

  12 Weeks

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.

  6 Month

• Pain Visual Analog Score (VAS)

  The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.

  6 Weeks

• Pain Visual Analog Score (VAS)

  The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.

  12 Weeks

• Pain Visual Analog Score (VAS)

  The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.

  6 Month

• Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores

  PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.

  6 Weeks

• Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores

  PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.

  12 Weeks

• Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores

  PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.

  6 Month

Study Arms (3)

Triamcinolone 40mg/mL

ACTIVE COMPARATOR

A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.

Drug: Triamcinolone Acetonide 40mg/mL

Triamcinolone 10mg/mL

ACTIVE COMPARATOR

A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.

Drug: Triamcinolone Acetonide 10mg/mL

Soluble dexamethasone 4mg/mL

ACTIVE COMPARATOR

A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.

Drug: Dexamethasone 4 mg/ml

Interventions

Triamcinolone Acetonide 40mg/mL DRUG

Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

Triamcinolone 40mg/mL

Triamcinolone Acetonide 10mg/mL DRUG

Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

Triamcinolone 10mg/mL

Dexamethasone 4 mg/ml DRUG

Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

Soluble dexamethasone 4mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• At least one symptomatic trigger finger
• Patients recommended to receive corticosteroid injections

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Triamcinolone Acetonide; Dexamethasone

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienetriols

Results Point of Contact

• Title: Vicki L Jones
• Organization: UMissourri

jonesvicki@health.missouri.edu

573-882-7583

Study Officials

• Daniel London, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 28, 2019
• Study Start: June 25, 2019
• Primary Completion: May 19, 2022
• Study Completion: January 1, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Locations

US (1)