search
Back to results

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

Primary Purpose

Trigger Finger

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic modalities: Orthotic (Group 1)
Therapeutic modalities: LLLT (Group 2)
Therapeutic modalities: Paraffin (Group 3)
Corticosteroid injection (Group 4)
Sponsored by
Beatriz Sernajoto Cristiani Pedro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring trigger finger, Therapeutic Modalities, Corticosteroid Injection, non-surgical treatment, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ...)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Therapeutic Modalities

    Corticosteroid injection

    Arm Description

    Group 1: Metal orthotic, keeping 0º of the extension of the proximal interphalangeal joint, during all day, for 5 weeks, stopping the use only for bathing Group 2: 10 LLLT sessions applications on the A1 pulley and lump formed on the flexor tendon of the the affected finger; Two sessions per week, five weeks of treatment. Group 3: Paraffin bath 2 times a week for 20 minutes (total of 10 sessions).

    Group 4: Corticosteroid injection in the A1 pulley, 1 application.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Changes in Visual Analogue Scale (VAS)
    Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
    Changes in SF-12 (quality of life)
    Changes in the numbers of the Complications
    Changes in the numbers of the Relapses

    Full Information

    First Posted
    November 7, 2016
    Last Updated
    July 5, 2017
    Sponsor
    Beatriz Sernajoto Cristiani Pedro
    Collaborators
    Federal University of São Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02972879
    Brief Title
    Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial
    Official Title
    Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Beatriz Sernajoto Cristiani Pedro
    Collaborators
    Federal University of São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trigger Finger
    Keywords
    trigger finger, Therapeutic Modalities, Corticosteroid Injection, non-surgical treatment, physical therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic Modalities
    Arm Type
    Active Comparator
    Arm Description
    Group 1: Metal orthotic, keeping 0º of the extension of the proximal interphalangeal joint, during all day, for 5 weeks, stopping the use only for bathing Group 2: 10 LLLT sessions applications on the A1 pulley and lump formed on the flexor tendon of the the affected finger; Two sessions per week, five weeks of treatment. Group 3: Paraffin bath 2 times a week for 20 minutes (total of 10 sessions).
    Arm Title
    Corticosteroid injection
    Arm Type
    Active Comparator
    Arm Description
    Group 4: Corticosteroid injection in the A1 pulley, 1 application.
    Intervention Type
    Procedure
    Intervention Name(s)
    Therapeutic modalities: Orthotic (Group 1)
    Other Intervention Name(s)
    Metal orthotic
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Therapeutic modalities: LLLT (Group 2)
    Other Intervention Name(s)
    Ibramed's LASERPULSED 904nm
    Intervention Description
    The LLLT parameters are: LASER 904nm P: 1.5W/cm² 30mV/cm² Area 2 cm² 1 Joule por ponto ( in the A1 pulley)
    Intervention Type
    Procedure
    Intervention Name(s)
    Therapeutic modalities: Paraffin (Group 3)
    Other Intervention Name(s)
    Bath Paraffin Carci´s
    Intervention Description
    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":
    Intervention Type
    Procedure
    Intervention Name(s)
    Corticosteroid injection (Group 4)
    Other Intervention Name(s)
    Bethametasone
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in the Resolution/cure of the trigger finger until the six months of the treatment
    Description
    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.
    Time Frame
    1, 5, 12 weeks and 6 month
    Secondary Outcome Measure Information:
    Title
    Changes in Visual Analogue Scale (VAS)
    Time Frame
    1, 5, 12 weeks and 6 month
    Title
    Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
    Time Frame
    1, 5, 12 weeks and 6 month
    Title
    Changes in SF-12 (quality of life)
    Time Frame
    1, 5, 12 weeks and 6 month
    Title
    Changes in the numbers of the Complications
    Time Frame
    1, 5, 12 weeks and 6 month
    Title
    Changes in the numbers of the Relapses
    Time Frame
    1, 5, 12 weeks and 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 ...)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Beatriz S C Pedro
    Phone
    05511998035668
    Email
    bscristiani@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    3918652
    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. doi: 10.1136/bmj.290.6467.512.
    Results Reference
    background
    PubMed Identifier
    19006759
    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.
    Results Reference
    background
    PubMed Identifier
    24391799
    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.
    Results Reference
    background
    PubMed Identifier
    22189188
    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.
    Results Reference
    background
    PubMed Identifier
    24821018
    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.
    Results Reference
    background
    PubMed Identifier
    17549185
    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.
    Results Reference
    background
    PubMed Identifier
    19160256
    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.
    Results Reference
    background
    PubMed Identifier
    24810861
    Citation
    Huisstede BM, Hoogvliet P, Coert JH, Friden 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.
    Results Reference
    background
    PubMed Identifier
    21166589
    Citation
    Renno 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.
    Results Reference
    background
    PubMed Identifier
    21816888
    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.
    Results Reference
    background
    PubMed Identifier
    7367373
    Citation
    Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22265444
    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.
    Results Reference
    background
    PubMed Identifier
    23335238
    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.
    Results Reference
    background
    PubMed Identifier
    23187044
    Citation
    Dilek B, Gozum M, Sahin E, Baydar M, Ergor G, El O, Bircan C, Gulbahar 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.
    Results Reference
    background
    PubMed Identifier
    24353596
    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.
    Results Reference
    background
    PubMed Identifier
    15866967
    Citation
    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. doi: 10.2106/JBJS.D.02060.
    Results Reference
    background
    PubMed Identifier
    8628042
    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. doi: 10.1097/00005650-199603000-00003.
    Results Reference
    background
    Links:
    URL
    http://www.walt.nu/dosage-recommendations.html
    Description
    World Association of Laser Therapy. Recommended antiinflammatory dosage for low level laser therapy. 2005. (accessed june 20, 2017).

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs