Overview

This trial is active, not recruiting.

Conditions chronic pain, hallux valgus
Treatments active tdcs, sham tdcs
Phase phase 2
Sponsor Hospital de Clinicas de Porto Alegre
Collaborator Hospital Independencia
Start date December 2014
End date November 2015
Trial size 41 participants
Trial identifier NCT02360462, 14-0643

Summary

This is a clinical trial that intend to determine if transcranial direct current stimulation (tDCS) is effective in the treatment of postoperative pain and in the anxiety level in the preoperative period of hallux valgus surgical treatment

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Active tDCS will be applied in the head of the patients in 20 minute sessions, twice. First session will be applied in the night before and the second session, in the morning before the surgical procedure. The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area, and it will use a 2 mA current
active tdcs transcranial direct current stimulation (tDCS)
The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area and it will use a 2 mA (milliampere) current.
(Sham Comparator)
The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
sham tdcs Sham transcranial direct current stimulation (Sham tDCS)
The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after stimulation starts (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session

Primary Outcomes

Measure
Change in pain scores assessed with the visual analogue scale
time frame: Once Daily. It starts in the day before surgical treatment (Day 0), and it is assessed every day until one week after the surgical procedure (total = 10 days)

Secondary Outcomes

Measure
Preoperative Anxiety level
time frame: Initial contact (before any tDCS session - Day 0) and the moment before the surgical procedure (Day 1)
Change in the temperature pain threshold
time frame: Day before the surgical treatment (Day 0), and in the moment after the spinal anesthesia recovery in immediate postoperative period (Day 1).
Change in effect of the descendent modulator system of pain
time frame: Day before the surgical treatment (Day 0), and in the moment after the spinal anesthesia recovery in immediate postoperative period (Day 1).
Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF), S100B, nerve growth factor (NGF) and enolase
time frame: The day before the surgical treatment (Day 0), in the moment before the spinal anestesia (Day 1) and a week after the surgical procedure (Day 9)

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - indication of hallux valgus surgical treatment because of arthralgia of the first metatarsophalangeal joint, - capability of writing and understanding the Portuguese language Exclusion Criteria: - diabetic neuropathy, - history of intense or frequent headache, - chronic dermatologic disease, - previous adverse effects to treatment with tDCS, seizures, - severe cranial trauma with alteration of the cranial anatomy, - metallic intracranial implants or pacemaker, - non-compensated psychiatric disease, - non-collaborative patients, - history of neurologic, - oncologic disease, - heart, renal or hepatic failure.

Additional Information

Official title The Effect of tDCS in the Preoperative Period of Hallux Valgus Surgical Treatment
Principal investigator Wolnei Caumo, MD, PhD
Description Introduction: Forefoot deformities are important cause of feet pain and discomfort and affect around 80% of general population, predominantly in female population. Among teenagers and adults´ common forefoot deformities is hallux valgus. To achieve the deformity heal, surgical treatment is needed. The transcranial direct current stimulation (tDCS) is a non invasive technic, that aims for the central nervous system modulation for pain control, which can become a therapeutic option for postoperative pain. Experimental studies have shown that tDCS has reverted the hyperalgesia induced by chronic stress and articular inflammatory pain, has reduced total knee arthroplasty postoperative opioid consumption and a single 20 minutes session has shown reduction in endoscopic procedures opioid consumption, safety and minimal adverse effects. However, the tDCS effect in preoperative hyperalgesia has not been explored yet in sensitized patients, neither in anxiety and postoperative rehabilitation of patients submitted to hallux valgus surgical correction. In this study, it was chosen to use tDCS to stimulate cerebral cortex due to its efficacy in painful syndromes, for being a non invasive, low cost and easy-to-apply technic in comparison to other neurostimulation technics and especially, for its potential to counter-regulate the mal adaptive neuroplastic alterations associated to chronic pain. Objective: to evaluate the effect of tDCS compared to tDCS-sham in the pain control (visual analog scale score, pain threshold and the descendent modulator system), perioperative anxiety, postoperative analgesic drug consumption and in the rehabilitation of patients with arthralgia of the first metatarsophalangeal articulation submitted to hallux valgus surgical correction. Method: it is a randomized, blinded, placebo-sham controlled clinical trial which includes 40 female patients, between 18 and 70 years old, candidates to hallux valgus surgical treatment by combined Chevron + Akin osteotomy due to arthralgia of the first metatarsophalangeal articulation. The patients will be randomized and divided into two groups that will be treated with two tDCS or tDCS-sham sessions of 20 minutes each in preoperative period. Expected results: This study will evaluate the effect of tDCS as a treatment option to postoperative pain and perioperative anxiety of patients submitted to hallux valgus surgical correction. In case of proven efficacy, this technic can become a low cost, easy access, safe and effective treatment option for these patients.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.