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CompletedNCT06288685Updated Mar 12, 2024

Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone

A Phase 3 interventional study of percutaneous A1 pulley release and Triamcinolone in Trigger Finger, Percutaneous A1 Pulley Release and Steroid Injection, sponsored by Police General Hospital, Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Police General Hospital, Thailand · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Background:

Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.

Objective:

To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.

Study Design \& Methods:

This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications.

Read the detailed description

Material and Methods

Study Population:

Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study [ ]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases.

Group allocation and Randomization:

Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ).

Surgical Technique:

The surgical procedure followed Eastwood's method [ ], involving the following steps:

  1. Preparation of the sterile field.
  2. Injection of 1% lidocaine with epinephrine at the surgical site.
  3. Insertion of an 18-gauge needle following the tract from the previous injection.
  4. Patient extension of the finger to bring flexor tendons close to the skin, moving the neurovascular structures away.
  5. Slow penetration of the needle until it is over the A1 pulley.
  6. Gentle flexion of the finger while observing the needle tip to prevent penetrating the flexor tendon.
  7. Rotation of the needle bevel into a longitudinal orientation to the flexor tendon.
  8. Release of the A1 pulley by moving the needle upward and downward parallel to the flexor tendon until complete release is achieved.
  9. Withdrawal of the needle while hyperextending the finger.
  10. Flexion and extension of the finger to check for triggering.
  11. Injection of triamcinolone (40mg/ml) 1 ml in the study group.
  12. Closure of the wound with a small elastic dressing.

Postoperative Protocols:

Both groups received identical postoperative protocols, including the same medications (Augmentin, Naproxen, Tolperisone) for 7 days. Patients were encouraged for early finger range of motion without restriction.

Outcome Measures:

The primary outcome measure was pain score assessed by the VAS. Secondary outcomes included quality of life measured by the qDASH score, patient satisfaction, and surgical complications.

Follow-Up:

All cases underwent follow-up via telephone on postoperative days 1 to 6, in the clinic during the first and second weeks, and at 1 to 2 months postoperative.

Statistical analysis In this study, all data calculations were conducted using Stata software (version 17.0). Group comparisons involved the application of Pearson's chi-squared test or Continuity Correction chi-squared test for categorical variables, and the student's t-test was employed for continuous variables. Statistically significant differences were defined as those with a P-value \< 0.05.

02

Conditions studied

  • Trigger Finger
  • Percutaneous A1 Pulley Release
  • Steroid Injection
  • Postoperative Pain
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • clinical diagnosis of trigger finger
  • aged 18 years or older
  • trigger finger are classified under Quinell's grade 2, 3, or 4

Exclusion criteria

Exclusion Criteria:

  • a history of prior hand surgery
  • Dupuytren's disease
  • type 1 diabetes
  • previous phalangeal fractures
  • recent steroid injection within the last month
  • autoimmune diseases
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    group1

    percutaneous A1 pulley release with Triamcinolone injection

    Procedure: percutaneous A1 pulley release · Drug: Triamcinolone

  • Active comparator
    group0

    percutaneous A1 pulley release alone

    Procedure: percutaneous A1 pulley release

Interventions

  • Procedurepercutaneous A1 pulley release

    Treatment trigger finger by release A1 pulley by percutaneous procedure

  • DrugTriamcinolone

    Triamcinolone 40mg/ml 1 ml injection concomitant percutaneous A1 pulley release

05

What researchers measure

Primary outcomes

  1. postoperative pain score

    VAS(visual analog scale) from 0 to 10, 0 mean there is no pain, 10 there is the most pain in participants life

    Time frame: post operative Day0 until 2 months

Secondary outcomes

  1. hand function by quickDASH

    quickDASH(questionnaire in Thai version), score from 0-100, 0 mean there is no limitation of daily hand activity, 100 mean participants got disability in that upper limb

    Time frame: post operative Day0 until 2 months

  2. patients satisfaction

    1 is lowest satisfaction, 5 is most satisfaction

    Time frame: post operative Day0 until 2 months

06

Study locations

1 site
  • Police General Hospital
    Bangkok, Pathumwan 10330, Thailand
07

References and documents

Individual participant data

Plan to share: Yes — Sharing the Dermographic data of the participants including age, BMI, Occupation and sharing of pain score, quality of life and satisfaction in result table

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06288685
Lead sponsor
Police General Hospital, Thailand
Responsible party
Weeraphat Saartying (Orthopedic Resident, Police General Hospital, Thailand) — Principal investigator
First posted
Mar 1, 2024
Start date
Oct 11, 2023
Primary completion
Jan 23, 2024
Completion
Jan 30, 2024
Last update
Mar 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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