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

Study 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.

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

Conditions
-----------------
Trigger Finger

Intervention / Treatment
-----------------
* Procedure: Therapeutic modalities: Orthotic (Group 1)
* Procedure: Therapeutic modalities: LLLT (Group 2)
* Procedure: Therapeutic modalities: Paraffin (Group 3)
* Procedure: Corticosteroid injection (Group 4)


Participation Criteria
=================
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 ...)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapeutic Modalities<br>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)<br>* 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<br>* Other names: Metal orthotic;Procedure: Therapeutic modalities: LLLT (Group 2)<br>* The LLLT parameters are: LASER 904nm P: 1.5W/cm² 30mV/cm² Area 2 cm² 1 Joule por ponto ( in the A1 pulley)<br>* Other names: Ibramed's LASERPULSED 904nm;Procedure: Therapeutic modalities: Paraffin (Group 3)<br>* 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:<br>* Other names: Bath Paraffin Carci´s;|
| Active Comparator: Corticosteroid injection<br>Group 4: Corticosteroid injection in the A1 pulley, 1 application. | Procedure: Corticosteroid injection (Group 4)<br>* 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.<br>* 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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therapeutic Modalities, Corticosteroid Injection, trigger finger, non-surgical treatment, physical therapy