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

NCT02360462 | Completed

• 1 other identifier: 14-0643
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain; Hallux Valgus

Keywords

Transcranial Direct Current Stimulation; tDCS; Hallux Valgus; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain scores assessed with the visual analogue scale

  Patients will be asked their worst pain level (assessed by the Visual Analogue Scale) with 2 different scores: worst daily pain including movement period and pain in rest period. It will also be assessed a pain score for the moment before and another for the moment right after each tDCS session (Day 0 and Day 1). The outcome assessor will visit the patient once daily during the hospital stay (an expected average of 2 days) and will call the patient once daily after discharge. Patients will also be asked to daily write down the analgesic drug intake after hospital discharge and the outcome assessor will review nursery notes during hospital stay for drug intake. Total evaluations: 10 days

  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 (4)

• Preoperative Anxiety level

  Initial contact (before any tDCS session - Day 0) and the moment before the surgical procedure (Day 1)

• Change in the temperature pain threshold

  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

  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

  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)

Other Outcomes (1)

• Adverse Effects

  At the end of each tDCS session (Day 0 and Day 1)

Study Arms (2)

Active tDCS

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

Device: Active tDCS

Sham tDCS

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.

Device: Sham tDCS

Interventions

Active tDCS 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.

Also known as: transcranial direct current stimulation (tDCS)

Active tDCS

Sham tDCS 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

Also known as: Sham transcranial direct current stimulation (Sham tDCS)

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication of hallux valgus surgical treatment because of arthralgia of the first metatarsophalangeal joint,
• capability of writing and understanding the Portuguese language

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Hospital Independencia: collaborator

Study Sites (1)

Hospital Independência

Porto Alegre, Rio Grande do Sul, 91430-000, Brazil

Location

Related Publications (8)

• Valle A, Roizenblatt S, Botte S, Zaghi S, Riberto M, Tufik S, Boggio PS, Fregni F. Efficacy of anodal transcranial direct current stimulation (tDCS) for the treatment of fibromyalgia: results of a randomized, sham-controlled longitudinal clinical trial. J Pain Manag. 2009;2(3):353-361.

  PMID: 21170277 BACKGROUND

• Boros K, Poreisz C, Munchau A, Paulus W, Nitsche MA. Premotor transcranial direct current stimulation (tDCS) affects primary motor excitability in humans. Eur J Neurosci. 2008 Mar;27(5):1292-300. doi: 10.1111/j.1460-9568.2008.06090.x. Epub 2008 Feb 29.

  PMID: 18312584 BACKGROUND

• Nitsche MA, Liebetanz D, Antal A, Lang N, Tergau F, Paulus W. Modulation of cortical excitability by weak direct current stimulation--technical, safety and functional aspects. Suppl Clin Neurophysiol. 2003;56:255-76. doi: 10.1016/s1567-424x(09)70230-2. No abstract available.

  PMID: 14677403 BACKGROUND

• Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

  PMID: 20633386 BACKGROUND

• Fenton BW, Palmieri PA, Boggio P, Fanning J, Fregni F. A preliminary study of transcranial direct current stimulation for the treatment of refractory chronic pelvic pain. Brain Stimul. 2009 Apr;2(2):103-7. doi: 10.1016/j.brs.2008.09.009. Epub 2009 Feb 28.

  PMID: 20633407 BACKGROUND

• 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.

  PMID: 23171145 BACKGROUND

• 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.

  PMID: 23036076 BACKGROUND

• 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.

  PMID: 29190741 DERIVED

MeSH Terms

Conditions

Chronic Pain; Hallux Valgus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wolnei Caumo, MD, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 10, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

BR (1)