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

Not Applicable

• Conditions: Trigger Finger
• Interventions: Procedure: Corticosteroid injection (Group 4)

• Registration Number: NCT02972879
• Lead Sponsor: Beatriz Sernajoto Cristiani Pedro

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.

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-25
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-06
• Study Start: 2018-03-01
• Primary Completion: 2019-12
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid injection	Corticosteroid injection (Group 4)	Group 4: Corticosteroid injection in the A1 pulley, 1 application.

Primary Outcome Measures

Name	Time	Method
Changes in the Resolution/cure of the trigger finger until the six months of the treatment	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 Outcome Measures

Name	Time	Method
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