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Trigger Finger DisorderNCT06476977

Intrasynovial Digital Anesthesia in Trigger Finger

A study testing Dorsal webspace combined corticosteroid and anesthetic injection and Palmar combined corticosteroid and anesthetic injection in people with Trigger Finger Disorder, run by Kevin Zuo at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trigger Finger Disorder
What is being tested?
Dorsal webspace combined corticosteroid and anesthetic injection and Palmar combined corticosteroid and anesthetic injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
3 Jul 2024to Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kevin Zuo, MD, MASc contact

416-603-5802

kevin.zuo@uhn.ca

Canada1 site, 1 recruiting
  • University Health Network - Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

    Kevin Zuo, MD, MASc, 416-603-5802, kevin.zuo@uhn.ca

    Kevin Zuo, MD, MASc

    Recruiting

Other trials in Canada

About this study

Official title: Trigger Finger Corticosteroid Injection Pain: Palmar Injection Versus Dorsal Intrasynovial (Transthecal) Injection

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.

Read the detailed description

Trigger finger (stenosing tenosynovitis) is one of the most common pathologies assessed by hand surgeons in clinic. Trigger finger involves inflammation or edema of the flexor tendon causing friction of the tendon at the site of the A1 annular pulley located at the base of the affected finger in the palm. Trigger finger is typically managed non-surgically in a clinic setting with percutaneous corticosteroid injection (CSI) which can be successful in alleviating symptoms. Patients with trigger finger who do not respond to CSI, have incomplete relief, and/or who have recurrent symptoms may then receive surgical management with release of the A1 pulley.

CSIs for trigger fingers are among the most common procedures performed by hand surgeons and are often administered multiple times in a single clinic day. CSIs are frequently mixed 50:50 with 1% lidocaine to provide post-injection analgesia for patients as well as symptomatic relief of the trigger finger if acutely inflamed. These injections are commonly administered from a palmar approach into the A1 pulley of the affected digit. Numerous technical variations of palmar trigger finger injections have been described involving either subcutaneous injection superficial to the flexor tendon sheath or intrasynovial (transthecal) injection into the flexor tendon sheath.

Unfortunately, given the rich sensory innervation of the palmar skin, palmar injections are associated with significant pain as the needle pierces the skin. An alternative technique is to provide digital anesthesia from a dorsal webspace approach, injecting the local anesthetic into the flexor tendon synovial sheath. This intrasynovial or transthecal technique has the benefit of a dorsal approach where the skin is less sensitive resulting in less pain (6). This technique has been described previously but is not familiar to many hand surgeons and is not routinely used in North America.

Anecdotally, patients report significantly decreased pain with the dorsal intrasynovial injection technique for trigger finger injections, but pain scores have not been quantitatively evaluated or compared to the pain scores of traditional palmar trigger finger injections. Furthermore, it is not known what distribution of digital sensory blockade is achieved with this intrasynovial technique, particularly on the dorsal surface of the digit which is discontinuous with the flexor tendon sheath and innervated by the sensory branch of the radial nerve.

Accordingly, it is hypothesized that injecting corticosteroids into the synovial sheath of the flexor tendon will result in less pain over 24 hours if performed through the dorsal webspace versus the palmar side of the affected digit.

Being tested
Dorsal webspace combined corticosteroid and anesthetic injection, Palmar combined corticosteroid and anesthetic injection
Keywords
trigger finger, stenosing tenosynovitis, corticosteroid injection, palmar, dorsal, pain
Medical subject headings
Trigger Finger Disorder, Tendon Entrapment, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dorsal webspace combined corticosteroid and anesthetic injectionProcedure or surgery

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

  • Palmar combined corticosteroid and anesthetic injectionProcedure or surgery

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

Study groups in NCT06476977
Study groupRoleWhat they receive
Dorsal Webspace ApproachExperimentalA 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.
Receives: Procedure: Dorsal webspace combined corticosteroid and anesthetic injection
Palmar ApproachActive comparatorStandard 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.
Receives: Procedure: Palmar combined corticosteroid and anesthetic injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: measured at 0 hours, 4 hours, and 24 hours post-injection

  2. 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: measured at 0 hours, 4 hours, and 24 hours post-injection

  3. 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: measured at 0 hours, 4 hours, and 24 hours post-injection

Secondary outcomes (2)
  1. Sensory Assessment - Light Touch

    Semmes-Weinstein 2.0g monofilament test as threshold of sensory impairment

    Measured: measured at 0 hours post-injection

  2. Sensory Assessment - Pain

    Pinprick pain sensation with an 18-gauge sharp needle tip

    Measured: measured at 0 hours post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study start3 Jul 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476977
Sponsor's protocol ID
24-5288
Status last verified
Aug 2024
First submitted
20 Jun 2024
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15994689
  • 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.

    PubMed 19468879
  • 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.

    PubMed 17341673
  • 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.

    PubMed 32686570
  • 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.

    PubMed 31690121
  • 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.

    PubMed 32493111
  • 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.

    PubMed 37218106
  • 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.

    PubMed 28443675
  • 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.

    PubMed 24876694
  • 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.

    PubMed 34366261
  • 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.

    PubMed 16320034
  • 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.

    PubMed 1235985

Questions about this trial

What is this clinical trial studying?

A study testing Dorsal webspace combined corticosteroid and anesthetic injection and Palmar combined corticosteroid and anesthetic injection in people with Trigger Finger Disorder, run by Kevin Zuo at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kevin Zuo, MD, MASc (416-603-5802, kevin.zuo@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) - Pain (time frame: measured at 0 hours, 4 hours, and 24 hours post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476977, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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