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

July 5, 2017 updated by: Beatriz Sernajoto Cristiani Pedro
The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therapeutic Modalities
  • 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)
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
Other Names:
  • Metal orthotic
Procedure: 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)
Other Names:
  • Ibramed's LASERPULSED 904nm
Procedure: 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":
Other Names:
  • Bath Paraffin Carci´s
Active Comparator: Corticosteroid injection
Group 4: Corticosteroid injection in the A1 pulley, 1 application.
Procedure: 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.
Other Names:
  • Bethametasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Resolution/cure of the trigger finger until the six months of the treatment
Time Frame: 1, 5, 12 weeks and 6 month

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 Outcome Measures

Outcome Measure
Time Frame
Changes in Visual Analogue Scale (VAS)
Time Frame: 1, 5, 12 weeks and 6 month
1, 5, 12 weeks and 6 month
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: 1, 5, 12 weeks and 6 month
1, 5, 12 weeks and 6 month
Changes in SF-12 (quality of life)
Time Frame: 1, 5, 12 weeks and 6 month
1, 5, 12 weeks and 6 month
Changes in the numbers of the Complications
Time Frame: 1, 5, 12 weeks and 6 month
1, 5, 12 weeks and 6 month
Changes in the numbers of the Relapses
Time Frame: 1, 5, 12 weeks and 6 month
1, 5, 12 weeks and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beatriz Sernajoto Cristiani Pedro

Collaborators

Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSCPedro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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