The Effect of tDCS in the Preoperative Period of Hallux Valgus Surgical Treatment

NCT ID: NCT02360462

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-06-30

Brief 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

Detailed 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.

Conditions

Chronic Pain; Hallux Valgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS

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

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

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 tDCS

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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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

Interventions

Active 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.

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Other Intervention Names

transcranial direct current stimulation (tDCS); Sham transcranial direct current stimulation (Sham tDCS)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Independencia

UNKNOWN

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolnei Caumo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital Independência

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

PMID: 21170277 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Caumo W, Ruehlman LS, Karoly P, Sehn F, Vidor LP, Dall-Agnol L, Chassot M, Torres IL. Cross-cultural adaptation and validation of the profile of chronic pain: screen for a Brazilian population. Pain Med. 2013 Jan;14(1):52-61. doi: 10.1111/j.1526-4637.2012.01528.x. Epub 2012 Nov 21.

Reference Type: BACKGROUND

PMID: 23171145 (View on PubMed)

Sehn F, Chachamovich E, Vidor LP, Dall-Agnol L, de Souza IC, Torres IL, Fregni F, Caumo W. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the pain catastrophizing scale. Pain Med. 2012 Nov;13(11):1425-35. doi: 10.1111/j.1526-4637.2012.01492.x. Epub 2012 Oct 4.

Reference Type: BACKGROUND

PMID: 23036076 (View on PubMed)

Ribeiro H, Sesterhenn RB, Souza A, Souza AC, Alves M, Machado JC, Burger NB, Torres ILDS, Stefani LC, Fregni F, Caumo W. Preoperative transcranial direct current stimulation: Exploration of a novel strategy to enhance neuroplasticity before surgery to control postoperative pain. A randomized sham-controlled study. PLoS One. 2017 Nov 30;12(11):e0187013. doi: 10.1371/journal.pone.0187013. eCollection 2017.

Reference Type: DERIVED

PMID: 29190741 (View on PubMed)

Other Identifiers

14-0643

Identifier Type: -

Identifier Source: org_study_id