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Clinical Trials/NCT02972879
NCT02972879
Unknown
Not Applicable

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

Beatriz Sernajoto Cristiani Pedro0 sites132 target enrollmentMarch 1, 2018
ConditionsTrigger Finger

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trigger Finger
Sponsor
Beatriz Sernajoto Cristiani Pedro
Enrollment
132
Primary Endpoint
Changes in the Resolution/cure of the trigger finger until the six months of the treatment
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
July 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beatriz Sernajoto Cristiani Pedro
Responsible Party
Sponsor Investigator
Principal Investigator

Beatriz Sernajoto Cristiani Pedro

BSCPedro

Federal University of São Paulo

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 ...)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in the numbers of the Complications(1, 5, 12 weeks and 6 month)
  • 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 Relapses(1, 5, 12 weeks and 6 month)

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