Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial

Trigger Finger Clinical Trial

Official title:

Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02972879
• Other study ID #: BSCPedro
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: July 5, 2017
• Start date: March 1, 2018
• Est. completion date: July 2020

Study information

• Verified date: July 2017
• Source: Federal University of São Paulo
• Contact: Beatriz S C Pedro
• Phone: 05511998035668
• Email: bscristiani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger.

Description:

There are several forms of nonsurgical treatment for trigger finger, the most used are:

• Oral nonsteroidal and steroidal antiinflammatory's drugs use to resolve the inflammatory process

• Corticosteroids local injection: that proposes to control the inflammation, these injections have shown good effectiveness for trigger finger treatment.

• Orthotic: with the aim of to immobilize the affected joint until the resolution of the inflammatory process.

• Electrotherapeutic modalities:

• Paraffin that increases cellular metabolism and promotes peripheral vasodilatation, favoring the transduction tissue fluid, lymph flow, hyperemia and consequent absorption of exsudato.

• LASER -Lower Level Laser Therapy (LLLT): the absorption of light through the skin's photoreceptors stimulates mitochondrial chain reactions, promoting adenosine triphosphate (ATP) synthesis, acting on gene expression, which raises the level of growth factors and Tissue repair

Although the non-surgical treatment is often used there is no evidence in the literature of which is the most effective conservative treatment for trigger finger. Thus, it is necessary use appropriate methodology to define the benefits and harms of each treatment modality and assess the effectiveness of these nonsurgical treatments, and may define which one has a higher resolution and lower rates of trigger finger recurrences in short, medium and long term.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 2-3 grade of trigger finger (Quinnell´s classification)

• Signing the Terms of Consent.

Exclusion Criteria:

• Presence of finger trigger in children

• Presence of traumatic finger trigger

• Secondary causes (patients with tumor of the tendon sheath,

synovitis tuberculosis, etc ...)

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

Procedure:
• Therapeutic modalities: Orthotic (Group 1)
participants will be instructed to remove the orthosis only two hours in the morning, two hours in the afternoon and two hours at night to avoid joint stiffness
• Therapeutic modalities: LLLT (Group 2)
The LLLT parameters are: LASER 904nm P: 1.5W/cm² 30mV/cm² Area 2 cm² 1 Joule por ponto ( in the A1 pulley)
• Therapeutic modalities: Paraffin (Group 3)
Paraffin will be heated and maintained at 50 ° C. Participants will immerse their affected hand 10 times in heated paraffin, then they will roll up their affected hand in a towel that they will bring, after 20 minutes timed by a trained professional, the subjects will remove the towel and "paraffin glove":
• Corticosteroid injection (Group 4)
The injection solution is composed of 1 ml of betamethasone and 1 ml of 2% lidocaine.This group may repeat the procedure in two weeks if they report that there was no improvement of the triggering or pain.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beatriz Sernajoto Cristiani Pedro	Federal University of São Paulo

References & Publications (17)

Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. — View Citation

Binder A, Hodge G, Greenwood AM, Hazleman BL, Page Thomas DP. Is therapeutic ultrasound effective in treating soft tissue lesions? Br Med J (Clin Res Ed). 1985 Feb 16;290(6467):512-4. — View Citation

Chen PT, Lin CJ, Jou IM, Chieh HF, Su FC, Kuo LC. One digit interruption: the altered force patterns during functionally cylindrical grasping tasks in patients with trigger digits. PLoS One. 2013 Dec 31;8(12):e83632. doi: 10.1371/journal.pone.0083632. eCollection 2013. — View Citation

Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22. — View Citation

Dilek B, Gözüm M, Sahin E, Baydar M, Ergör G, El O, Bircan Ç, Gülbahar S. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):642-9. doi: 10.1016/j.apmr.2012.11.024. Epub 2012 Nov 24. — View Citation

Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18. Review. — View Citation

Howitt S, Wong J, Zabukovec S. The conservative treatment of Trigger thumb using Graston Techniques and Active Release Techniques. J Can Chiropr Assoc. 2006 Dec;50(4):249-54. — View Citation

Huisstede BM, Hoogvliet P, Coert JH, Fridén J; European HANDGUIDE Group. Multidisciplinary consensus guideline for managing trigger finger: results from the European HANDGUIDE Study. Phys Ther. 2014 Oct;94(10):1421-33. doi: 10.2522/ptj.20130135. Epub 2014 May 8. — View Citation

Langer D, Luria S, Maeir A, Erez A. Occupation-based assessments and treatments of trigger finger: a survey of occupational therapists from Israel and the United States. Occup Ther Int. 2014 Dec;21(4):143-55. doi: 10.1002/oti.1372. Epub 2014 May 12. — View Citation

Peters-Veluthamaningal C, van der Windt DA, Winters JC, Meyboom-de Jong B. Corticosteroid injection for trigger finger in adults. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD005617. doi: 10.1002/14651858.CD005617.pub2. Review. — View Citation

Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. — View Citation

Rennó AC, Toma RL, Feitosa SM, Fernandes K, Bossini PS, de Oliveira P, Parizotto N, Ribeiro DA. Comparative effects of low-intensity pulsed ultrasound and low-level laser therapy on injured skeletal muscle. Photomed Laser Surg. 2011 Jan;29(1):5-10. doi: 10.1089/pho.2009.2715. Epub 2010 Dec 18. — View Citation

Salim N, Abdullah S, Sapuan J, Haflah NH. Outcome of corticosteroid injection versus physiotherapy in the treatment of mild trigger fingers. J Hand Surg Eur Vol. 2012 Jan;37(1):27-34. doi: 10.1177/1753193411415343. Epub 2011 Aug 4. — View Citation

Sibtain F, Khan A, Shakil-Ur-Rehman S. Efficacy of Paraffin Wax Bath with and without Joint Mobilization Techniques in Rehabilitation of post-Traumatic stiff hand. Pak J Med Sci. 2013 Apr;29(2):647-50. — View Citation

Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20. — View Citation

Valdes K. A retrospective review to determine the long-term efficacy of orthotic devices for trigger finger. J Hand Ther. 2012 Jan-Mar;25(1):89-95; quiz 96. doi: 10.1016/j.jht.2011.09.005. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Resolution/cure of the trigger finger until the six months of the treatment	The patient must extend and flex the affected; finger 10 times to verify the presence or absence of the trigger finger and determine; the degree of commitment.	1, 5, 12 weeks and 6 month
Secondary	Changes in Visual Analogue Scale (VAS)		1, 5, 12 weeks and 6 month
Secondary	Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)		1, 5, 12 weeks and 6 month
Secondary	Changes in SF-12 (quality of life)		1, 5, 12 weeks and 6 month
Secondary	Changes in the numbers of the Complications		1, 5, 12 weeks and 6 month
Secondary	Changes in the numbers of the Relapses		1, 5, 12 weeks and 6 month

External Links

•   World Association of Laser Therapy. Recommended antiinflammatory dosage for low level laser therapy. 2005. (accessed june 20, 2017).