Intrasynovial Digital Anesthesia in Trigger Finger

August 15, 2024 updated by: Kevin Zuo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network - Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Kevin Zuo, MD, MASc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dorsal Webspace Approach
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
The dorsal webspace injection consists of a 1cc mixture of 0.5cc triamcinolone (Kenalog) 10mg/mL and 0.5cc 1% lidocaine for analgesic purposes.
Active Comparator: Palmar Approach
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
The palmar injection consists of a 1cc mixture of 0.5cc triamcinolone (Kenalog) 10mg/mL and 0.5cc 1% lidocaine for analgesic purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) - Pain
Time Frame: measured at 0 hours, 4 hours, and 24 hours post-injection
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
Time Frame: measured at 0 hours, 4 hours, and 24 hours post-injection
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)
Time Frame: measured at 0 hours, 4 hours, and 24 hours post-injection
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Assessment - Light Touch
Time Frame: measured at 0 hours post-injection
Semmes-Weinstein 2.0g monofilament test as threshold of sensory impairment
measured at 0 hours post-injection
Sensory Assessment - Pain
Time Frame: measured at 0 hours post-injection
Pinprick pain sensation with an 18-gauge sharp needle tip
measured at 0 hours post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kevin Zuo

Investigators

  • Principal Investigator: Kevin Zuo, MD, MASc, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5288

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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