NCT02972879

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

November 7, 2016

Last Update Submit

July 5, 2017

Conditions

Trigger Finger

Keywords

trigger fingerTherapeutic ModalitiesCorticosteroid Injectionnon-surgical treatmentphysical therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes in Visual Analogue Scale (VAS)

    1, 5, 12 weeks and 6 month

  • Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)

    1, 5, 12 weeks and 6 month

  • Changes in SF-12 (quality of life)

    1, 5, 12 weeks and 6 month

  • Changes in the numbers of the Complications

    1, 5, 12 weeks and 6 month

  • Changes in the numbers of the Relapses

    1, 5, 12 weeks and 6 month

Study Arms (2)

Therapeutic Modalities

ACTIVE COMPARATOR

* 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).

Procedure: Therapeutic modalities: Orthotic (Group 1)Procedure: Therapeutic modalities: LLLT (Group 2)Procedure: Therapeutic modalities: Paraffin (Group 3)

Corticosteroid injection

ACTIVE COMPARATOR

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

Procedure: Corticosteroid injection (Group 4)

Interventions

Therapeutic modalities: Orthotic (Group 1)PROCEDURE

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

Also known as: Metal orthotic
Therapeutic Modalities
Therapeutic modalities: LLLT (Group 2)PROCEDURE

The LLLT parameters are: * LASER 904nm * P: 1.5W/cm² * 30mV/cm² * Area 2 cm² * 1 Joule por ponto ( in the A1 pulley)

Also known as: Ibramed's LASERPULSED 904nm
Therapeutic Modalities
Therapeutic modalities: Paraffin (Group 3)PROCEDURE

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":

Also known as: Bath Paraffin Carci´s
Therapeutic Modalities
Corticosteroid injection (Group 4)PROCEDURE

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.

Also known as: Bethametasone
Corticosteroid injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • grade of trigger finger (Quinnell´s classification)
  • Signing the Terms of Consent.

You may not qualify if:

  • Presence of finger trigger in children
  • Presence of traumatic finger trigger
  • Secondary causes (patients with tumor of the tendon sheath,
  • synovitis tuberculosis, etc ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 3918652BACKGROUND

  • 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.

    PMID: 19006759BACKGROUND

  • 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.

    PMID: 24391799BACKGROUND

  • 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.

    PMID: 22189188BACKGROUND

  • 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.

    PMID: 24821018BACKGROUND

  • 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.

    PMID: 17549185BACKGROUND

  • 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;2009(1):CD005617. doi: 10.1002/14651858.CD005617.pub2.

    PMID: 19160256BACKGROUND

  • 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.

    PMID: 24810861BACKGROUND

  • 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.

    PMID: 21166589BACKGROUND

  • 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.

    PMID: 21816888BACKGROUND

  • Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.

    PMID: 7367373BACKGROUND

  • 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.

    PMID: 22265444BACKGROUND

  • 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.

    PMID: 23335238BACKGROUND

  • 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.

    PMID: 23187044BACKGROUND

  • 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.

    PMID: 24353596BACKGROUND

  • 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.

    PMID: 15866967BACKGROUND

  • 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.

    PMID: 8628042BACKGROUND

Related Links

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Beatriz S C Pedro

CONTACT

05511998035668bscristiani@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
BSCPedro

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 25, 2016

Study Start

March 1, 2018

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share