Intrasynovial Digital Anesthesia in Trigger Finger

NCT06476977 | Recruiting

• 1 other identifier: 24-5288
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Trigger finger is a common disease of the hand involving swelling and inflammation of the tendon which flexes a finger, causing catching, locking, and/or pain. Trigger finger is typically treated by hand surgeons with a steroid injection through the front/palm side of the hand into the area near the tendon (i.e., at the base of the affected finger). This steroid injection is often combined with a local anesthetic (numbing agent) to help reduce short-term pain from the injection. However, the front/palm side of the hand is known to be very sensitive, and the steroid injection can be quite painful as the needle pierces the front/palm skin. To reduce the pain of steroid injections for trigger finger, a different approach involves performing the injection from the back/dorsal side of the hand, which is thought to be less sensitive (and therefore less painful) than the front/palm side of the hand. This technique is sometimes used and has been previously studied, but it is not clear if it can offer less injection-related pain than standard treatment. Accordingly, this study will be comparing short-term injection-associated pain between front/palm side and back/dorsal side steroid injections for trigger finger. The study will also seek to understand what area of the hand is numbed by the anesthetic when doing a front/palm side injection versus a back/dorsal side injection of the hand. Overall, the investigators hypothesize that back/dorsal side injections will be less painful than front/palm side injections for trigger fingers and that the area of numbing from the anesthetic will be equivalent between both types of injections.

Conditions

Trigger Finger Disorder

Keywords

trigger finger; stenosing tenosynovitis; corticosteroid injection; palmar; dorsal; pain

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale (VAS) - Pain

  100mm mechanical rating scale for pain, ranging from 0mm ("no pain") to 100mm ("pain as bad as it could be"); higher scores indicate a worse outcome.

  measured at 0 hours, 4 hours, and 24 hours post-injection

• Numerical Rating Scale (NRS) - Pain

  11-point numerical rating scale for pain, ranging from 0 (no pain) to 10 (worst pain ever possible); higher scores indicate a worse outcome.

  measured at 0 hours, 4 hours, and 24 hours post-injection

• Short-Form McGill Pain Questionnaire (SFMPQ) - Present Pain Intensity (PPI)

  5-point combined numerical-word rating scale for pain, ranging from 1 (mild) to 5 (excruciating); higher scores indicate a worse outcome.

  measured at 0 hours, 4 hours, and 24 hours post-injection

Secondary Outcomes (2)

• Sensory Assessment - Light Touch

  measured at 0 hours post-injection

• Sensory Assessment - Pain

  measured at 0 hours post-injection

Study Arms (2)

Dorsal Webspace Approach

EXPERIMENTAL

A dorsal approach involves passing the needle with a 1:1 triamcinolone and lidocaine mixture in the dorsal webspace skin aiming just palmar to the proximal phalanx bone such that the needle is directed into the flexor tendon sheath at the A1 annular pulley.

Procedure: Dorsal webspace combined corticosteroid and anesthetic injection

Palmar Approach

ACTIVE COMPARATOR

Standard approach for injecting the 1:1 triamcinolone and lidocaine mixture involves the needle passing through the cutaneous and subcutaneous layers of the palmar skin surface and into the flexor tendon sheath at the A1 annular pulley.

Procedure: Palmar combined corticosteroid and anesthetic injection

Interventions

Dorsal webspace combined corticosteroid and anesthetic injection PROCEDURE

The dorsal webspace injection consists of a 1cc mixture of 0.5cc triamcinolone (Kenalog) 10mg/mL and 0.5cc 1% lidocaine for analgesic purposes.

Dorsal Webspace Approach

Palmar combined corticosteroid and anesthetic injection PROCEDURE

The palmar injection consists of a 1cc mixture of 0.5cc triamcinolone (Kenalog) 10mg/mL and 0.5cc 1% lidocaine for analgesic purposes.

Palmar Approach

Eligibility Criteria

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

You may qualify if:

• Be 18 years of age or older
• Have a diagnosis of trigger finger (can be any of the 5 digits)
• Opting to receive a CSI for their triggering finger

You may not qualify if:

• Decline to obtain a CSI for trigger finger management
• Receiving multiple CSI for trigger finger management at the appointment
• Past CSI and/or surgery to the digit involved
• Unable to communicate in English

Sponsors & Collaborators

• Kevin Zuo: lead

Study Sites (1)

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (12)

• Akhtar S, Bradley MJ, Quinton DN, Burke FD. Management and referral for trigger finger/thumb. BMJ. 2005 Jul 2;331(7507):30-3. doi: 10.1136/bmj.331.7507.30. No abstract available.

  PMID: 15994689 BACKGROUND

• Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.

  PMID: 19468879 BACKGROUND

• Fleisch SB, Spindler KP, Lee DH. Corticosteroid injections in the treatment of trigger finger: a level I and II systematic review. J Am Acad Orthop Surg. 2007 Mar;15(3):166-71. doi: 10.5435/00124635-200703000-00006.

  PMID: 17341673 BACKGROUND

• Merry SP, O'Grady JS, Boswell CL. Trigger Finger? Just Shoot! J Prim Care Community Health. 2020 Jan-Dec;11:2150132720943345. doi: 10.1177/2150132720943345.

  PMID: 32686570 BACKGROUND

• Patrinely JR Jr, Johnson SP, Drolet BC. Trigger Finger Corticosteroid Injection With and Without Local Anesthetic: A Randomized, Double-Blind Controlled Trial. Hand (N Y). 2021 Sep;16(5):619-623. doi: 10.1177/1558944719884663. Epub 2019 Nov 5.

  PMID: 31690121 BACKGROUND

• Jimenez I, Garces GL, Marcos-Garcia A, Medina J. A randomized controlled trial of dorsal web space versus palmar midline injection of steroid in the treatment of trigger digits. J Hand Surg Eur Vol. 2020 Dec;45(10):1071-1077. doi: 10.1177/1753193420927999. Epub 2020 Jun 3.

  PMID: 32493111 BACKGROUND

• Bitar H, Zachrisson AK, Bystrom M, Stromberg J. Day-by-day symptom relief after corticosteroid injection for trigger digit: a randomized controlled study of two techniques. J Hand Surg Eur Vol. 2023 Oct;48(9):849-856. doi: 10.1177/17531934231177422. Epub 2023 May 22.

  PMID: 37218106 BACKGROUND

• Rosenbaum YA, Benvenuti N, Yang J, Ruff ME, Awan HM, Samora JB. The Effect of Trigger Finger Injection Site on Injection-Related Pain. Hand (N Y). 2018 Mar;13(2):164-169. doi: 10.1177/1558944717703134. Epub 2017 Apr 26.

  PMID: 28443675 BACKGROUND

• Mathew A. Mid-axial injection of steroid into the flexor sheath for trigger fingers. J Hand Microsurg. 2014 Jun;6(1):49-52. doi: 10.1007/s12593-014-0120-z. Epub 2014 Feb 21. No abstract available.

  PMID: 24876694 BACKGROUND

• Jimenez I, Medina J, Marcos-Garcia A, Garces GL. Out-of-sheath corticosteroid injections through the dorsal webspace for trigger finger and trigger thumb. A prospective cohort study. Rev Esp Cir Ortop Traumatol. 2022 Jul-Aug;66(4):260-266. doi: 10.1016/j.recot.2021.03.009. Epub 2021 Aug 6. English, Spanish.

  PMID: 34366261 BACKGROUND

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

• Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.

  PMID: 1235985 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder; Tendon Entrapment; Pain

Interventions

Anesthetics

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Kevin Zuo, MD, MASc

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Zuo, MD, MASc

CONTACT

416-603-5802; kevin.zuo@uhn.ca

Daniel Antflek, BSc

CONTACT

416-603-5800; daniel.antflek@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Surgeon, Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: July 3, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CA (1)