- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05383040
Percutaneous Release vs Steroid Injection for Trigger Finger
Comparison of Percutaneous Release and Local Steroid Injection for the Treatment of Trigger Fingers: A Randomized Clinical Trial
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dev R Sunuwar, M.Sc
- Phone Number: 9851147339
- Email: devramsunuwar@gmail.com
Study Locations
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Bagmati
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Kathmandu, Bagmati, Nepal, +9779851147339
- Armed Police Force Hospital
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Contact:
- Dev R Sunuwar, M.Sc
- Email: devramsunuwar@gmail.com
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Sub-Investigator:
- Narendra Chaudhary, M.Sc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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: percutaneous release
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.
|
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.
|
No Intervention: Steroid injection
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional mobility improvement
Time Frame: 3 months
|
Compare the effects of percutaneous release versus steroid injection on functional mobility at baseline, one month and three months.
|
3 months
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Pain reduction
Time Frame: 3 months
|
Compare the effects of percutaneous release versus steroid injection on pain reduction at baseline, one month and three months.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in the thickness of the A1 pulley
Time Frame: 3 months
|
Compare the effects of percutaneous release versus steroid injection on decrease in the thickness at baseline, one month and three months.
|
3 months
|
Recurrence of problem within 3 months
Time Frame: 3 months
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Compare the effects of percutaneous release with steroid injection on problem recurrence in three months.
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Mandeep Karki, MS, Nepal Orthopedic Hospital
Publications and helpful links
General Publications
- Moore JS. Flexor tendon entrapment of the digits (trigger finger and trigger thumb). J Occup Environ Med. 2000 May;42(5):526-45. doi: 10.1097/00043764-200005000-00012.
- Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4.
- 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.
- Mineoka Y, Ishii M, Hashimoto Y, Yuge H, Toyoda M, Nakamura N, Katsumi Y, Fukui M. Trigger finger is associated with risk of incident cardiovascular disease in individuals with type 2 diabetes: a retrospective cohort study. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e002070. doi: 10.1136/bmjdrc-2020-002070.
- David M, Rangaraju M, Raine A. Acquired triggering of the fingers and thumb in adults. BMJ. 2017 Nov 30;359:j5285. doi: 10.1136/bmj.j5285. No abstract available.
- Lunsford D, Valdes K, Hengy S. Conservative management of trigger finger: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):212-221. doi: 10.1016/j.jht.2017.10.016. Epub 2017 Dec 28.
- Takahashi M, Sato R, Kondo K, Sairyo K. Morphological alterations of the tendon and pulley on ultrasound after intrasynovial injection of betamethasone for trigger digit. Ultrasonography. 2018 Apr;37(2):134-139. doi: 10.14366/usg.17038. Epub 2017 Jul 25.
- Pan M, Sheng S, Fan Z, Lu H, Yang H, Yan F, E Z. Ultrasound-Guided Percutaneous Release of A1 Pulley by Using a Needle Knife: A Prospective Study of 41 Cases. Front Pharmacol. 2019 Mar 26;10:267. doi: 10.3389/fphar.2019.00267. eCollection 2019.
- Bianchi S, Gitto S, Draghi F. Ultrasound Features of Trigger Finger: Review of the Literature. J Ultrasound Med. 2019 Dec;38(12):3141-3154. doi: 10.1002/jum.15025. Epub 2019 May 20.
- LORTHIOIR J Jr. Surgical treatment of trigger-finger by a subcutaneous method. J Bone Joint Surg Am. 1958 Jul;40-A(4):793-5. No abstract available.
- Blumberg N, Arbel R, Dekel S. Percutaneous release of trigger digits. J Hand Surg Br. 2001 Jun;26(3):256-7. doi: 10.1054/jhsb.2001.0569.
- Park MJ, Oh I, Ha KI. A1 pulley release of locked trigger digit by percutaneous technique. J Hand Surg Br. 2004 Oct;29(5):502-5. doi: 10.1016/j.jhsb.2004.03.015.
- Ragoowansi R, Acornley A, Khoo CT. Percutaneous trigger finger release: the 'lift-cut' technique. Br J Plast Surg. 2005 Sep;58(6):817-21. doi: 10.1016/j.bjps.2005.04.003.
- Eastwood DM, Gupta KJ, Johnson DP. Percutaneous release of the trigger finger: an office procedure. J Hand Surg Am. 1992 Jan;17(1):114-7. doi: 10.1016/0363-5023(92)90125-9.
- Lyu SR. Closed division of the flexor tendon sheath for trigger finger. J Bone Joint Surg Br. 1992 May;74(3):418-20. doi: 10.1302/0301-620X.74B3.1587893.
- Bain GI, Turnbull J, Charles MN, Roth JH, Richards RS. Percutaneous A1 pulley release: a cadaveric study. J Hand Surg Am. 1995 Sep;20(5):781-4; discussion 785-6. doi: 10.1016/S0363-5023(05)80430-7.
- HOWARD LD Jr, PRATT DR, BUNNELL S. The use of compound F (hydrocortone) in operative and non-operative conditions of the hand. J Bone Joint Surg Am. 1953 Oct;35-A(4):994-1002. No abstract available.
- Dala-Ali BM, Nakhdjevani A, Lloyd MA, Schreuder FB. The efficacy of steroid injection in the treatment of trigger finger. Clin Orthop Surg. 2012 Dec;4(4):263-8. doi: 10.4055/cios.2012.4.4.263. Epub 2012 Nov 16.
- Wang J, Zhao JG, Liang CC. Percutaneous release, open surgery, or corticosteroid injection, which is the best treatment method for trigger digits? Clin Orthop Relat Res. 2013 Jun;471(6):1879-86. doi: 10.1007/s11999-012-2716-6. Epub 2012 Dec 4.
- Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.
- Sato ES, Gomes Dos Santos JB, Belloti JC, Albertoni WM, Faloppa F. Treatment of trigger finger: randomized clinical trial comparing the methods of corticosteroid injection, percutaneous release and open surgery. Rheumatology (Oxford). 2012 Jan;51(1):93-9. doi: 10.1093/rheumatology/ker315. Epub 2011 Oct 29.
- Sahu R, Gupta P. Experience of Percutaneous Trigger Finger Release under Local Anesthesia in the Medical College of Mullana, Ambala, Haryana. Ann Med Health Sci Res. 2014 Sep;4(5):806-9. doi: 10.4103/2141-9248.141558.
- Ha KI, Park MJ, Ha CW. Percutaneous release of trigger digits. J Bone Joint Surg Br. 2001 Jan;83(1):75-7. doi: 10.1302/0301-620x.83b1.11247.
- Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Trigger finger
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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