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Percutaneous Release vs Steroid Injection for Trigger Finger

Primary Purpose

Trigger Finger

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Percutaneous release
Sponsored by
Armed Police Force Hospital, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring Trigger fingers, Trigger digits, Steroid injection, Percutaneous release

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants aged 18 years and above
  • Duration of symptoms :≥ 3 months
  • Triggering in any of the digits of hand
  • Trigger finger type II-IV based on Quinnell classification

Exclusion Criteria:

  • There is prior treatment for trigger finger, or Trigger thumb
  • There had been previous surgery or other hand pathology such as rheumatoid arthritis, osteoarthritis, Dupuytren's contracture and diabetic mellitus.

Sites / Locations

  • Armed Police Force Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

percutaneous release

Steroid injection

Arm Description

Percutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed.

The steroid injection mixed with 1 ml of methyl prednisone (40mg) with 0.5 ml of 2% plain lidocaine will be inserted into the flexor tendon sheath over the A1 pulley, which will also be performed in the operation theater for patient safety.

Outcomes

Primary Outcome Measures

Functional mobility improvement
Compare the effects of percutaneous release versus steroid injection on functional mobility at baseline, one month and three months.
Pain reduction
Compare the effects of percutaneous release versus steroid injection on pain reduction at baseline, one month and three months.

Secondary Outcome Measures

Decrease in the thickness of the A1 pulley
Compare the effects of percutaneous release versus steroid injection on decrease in the thickness at baseline, one month and three months.
Recurrence of problem within 3 months
Compare the effects of percutaneous release with steroid injection on problem recurrence in three months.

Full Information

First Posted
May 17, 2022
Last Updated
February 23, 2023
Sponsor
Armed Police Force Hospital, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT05383040
Brief Title
Percutaneous Release vs Steroid Injection for Trigger Finger
Official Title
Comparison of Percutaneous Release and Local Steroid Injection for the Treatment of Trigger Fingers: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Police Force Hospital, Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Trigger fingers (TF) is the common cause of pain and disturbed function of hand. Many studies show that percutaneous release of A1 pulley has better outcome than the steroid injection. However, over the past many years, steroid injection has been considered as the choice of treatment after the failure of conservative treatment methods. The aim of this study is to assess the effect of percutaneous release of A1 pulley compared with the local Steroid injection in the treatment of trigger fingers. This study is based on a randomized clinical trial to compare the effect of the percutaneous release of A1 pulley with steroid injection in trigger fingers. A total of 112 participants aged 18 years and above suffering from trigger fingers with failed conservative treatment will be intervened randomly (56 participants in injection group and 56 participants in percutaneous release group). The Quinnell's classification, VAS scoring system and active range of movement in the affected site will be assessed at the baseline and the same criteria will be at one month and three month as end line assessment. Statistical analyses will be performed using independent t-test and Mann Whitney U test to compare between the two means. The outcome of this study will help to guide the physicians to choose the better therapeutic approach among the patients suffering from trigger fingers.
Detailed Description
Stenosing flexor tenosynovitis also known as trigger finger. It is a common clinical condition where there is locking and clicking during flexion and extension of the involved digit or even locking. The trigger ring finger is the first commonest, and the trigger thumb is the second commonest of trigger fingers. Flexor tendon gliding motion is dependent on a 'Critical Tendon Sheath Caliber Tolerance' which allows passage of flexor tendon through the A1 pulley in the Metacarpophalangeal joint. The prevalence of trigger finger is 2 % in the general population, which is most common in women in the fifth or sixth decade of life. The possibility of a trigger finger is between 2 and 3% during the lifetime, which increases up to 10 % in diabetic patients. The trigger finger in diabetic patients suffered from worse renal function and glycemic control, along with a higher incidence of cardiovascular disease. The causes of Trigger finger are still not well known, some factors may increase the risk of developing the condition such as forceful hand activities (mechanical irritation, congenital and medical conditions (Diabetes and Rheumatoid arthritis). Trigger thumb is caused by thickening of flexor tendon gliding at the tendon A1 pulley interface or thickening of A1 pulley. Diagnosis is primarily made based on physical examination. The patients often present with pain or clicking at the metacarpal head, which causes difficulty in holding or grasping objects. In most advanced cases, there is locking in flexion or extension position. Nowadays, the morphological changes in the case of trigger fingers can be ruled out by high-resolution ultrasonography with a high-frequency transducer, and it has been found that the cut-off for pathological findings is a 20% increase in tendon thickness compared to the contralateral tendon. The average width and thickness of the A1 pulley are 7.1 mm and less than 1 mm respectively. Treatment of Trigger fingers includes conservative such as splinting, oral medications, injection, and surgical management such as open release, and percutaneous release. Steroid injection has been serving us as a traditional way of injection therapy for many years for those who are not getting better with oral medications and physiotherapy. Steroid injection is effective because of its anti-inflammatory properties. The first percutaneous release was performed in 1958 and the success rate was 100% without any reported complications. Percutaneous A1 pulley release has been the method of choice for patients who does not respond to conservative treatment (local steroid) with low complication rates. There is a concern regarding percutaneous release in the thumb, where tendon sheath and neurovascular bundle are in proximity. The technique of local steroid injection into the flexor sheath was described by Howard in 1953. It has become an accepted initial treatment for trigger fingers largely due to its use within the outpatient department and its low complication rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Trigger fingers, Trigger digits, Steroid injection, Percutaneous release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A hospital-based randomized clinical trial study will be carried out to compare the effect of percutaneous release of A1 pulley with steroid injection in the treatment for trigger finger.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
percutaneous release
Arm Type
Experimental
Arm Description
Percutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed.
Arm Title
Steroid injection
Arm Type
No Intervention
Arm Description
The steroid injection mixed with 1 ml of methyl prednisone (40mg) with 0.5 ml of 2% plain lidocaine will be inserted into the flexor tendon sheath over the A1 pulley, which will also be performed in the operation theater for patient safety.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous release
Intervention Description
Percutaneous release of A1 pulley release will be performed in the well-managed operation theater set up, using an 18 gauge hypodermic needle, after preparation of the skin and injection of 1ml 2% plain lidocaine. The proper location of the pulley will be defined using surface landmarks in each digit after waiting a few minutes to allow the anesthetic to take effect the 18 gauge needle will be longitudinally moved to keep the level of the needle parallel with the tendon grating sensation will be elucidated confirming the cut of pulley until there is no grating sensation felt and improvement of symptoms. A sterile dressing will be placed.
Primary Outcome Measure Information:
Title
Functional mobility improvement
Description
Compare the effects of percutaneous release versus steroid injection on functional mobility at baseline, one month and three months.
Time Frame
3 months
Title
Pain reduction
Description
Compare the effects of percutaneous release versus steroid injection on pain reduction at baseline, one month and three months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Decrease in the thickness of the A1 pulley
Description
Compare the effects of percutaneous release versus steroid injection on decrease in the thickness at baseline, one month and three months.
Time Frame
3 months
Title
Recurrence of problem within 3 months
Description
Compare the effects of percutaneous release with steroid injection on problem recurrence in three months.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants aged 18 years and above Duration of symptoms :≥ 3 months Triggering in any of the digits of hand Trigger finger type II-IV based on Quinnell classification Exclusion Criteria: There is prior treatment for trigger finger, or Trigger thumb There had been previous surgery or other hand pathology such as rheumatoid arthritis, osteoarthritis, Dupuytren's contracture and diabetic mellitus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandeep Karki, MS
Organizational Affiliation
Nepal Orthopedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Police Force Hospital
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
+9779851147339
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Percutaneous Release vs Steroid Injection for Trigger Finger

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