Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms.

Detailed Description
-----------------
Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of men and women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, functional performance, central sensitization, quality of life, pressure pain threshold, global impression of change, adverse events and medication use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.

Official Title
-----------------
The Effects of Transcranial Direct Current Stimulation Combined With Pilates Based Exercise in the Treatment of Patients With Chronic Low Back Pain

Conditions
-----------------
Low Back Pain, Transcranial Direct Current Stimulation

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation
* Device: Sham Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale. Exclusion Criteria: diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year; low cognitive level assessed by the Mini Mental State Examination; presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia); history of epileptic illness; seizure history; brain implants; pacemaker; pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation + exercise group<br>30-minute exercise program (based on Pilates method) combined with active transcranial direct current stimulation. | Device: Transcranial direct current stimulation<br>* Exercise protocol + application of active direct current stimulation for 30 minutes.<br>|
| Sham Comparator: Sham stimulation + exercise group<br>This arm will perform the same procedures of experimental group but the stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session. | Device: Sham Transcranial direct current stimulation<br>* Exercise protocol + application of simulation of direct current stimulation for 30 minutes. The stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity measured by numerical pain rating scale (11 points scale) | Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up | 
| Functional performance associated to back pain | Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 itens) | Change from baseline in functional performance at four weeks after intervention and 1 month of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold | Pressure pain threshold measured by pressure algometer. | Change from baseline in pressure pain threshold at four weeks after intervention and 1 month of follow-up | 
| Individual quality of life | Measurement of quality of life using SF-36 questionnaire (36 items, divided into 8 subscales) | Change from baseline in quality of life questionnaires at four weeks after intervention and 1 month of follow-up | 
| Patient global impression of change | Patient global impression of change measured by a scale with seven points, where 1 is equal to no change or worse and 7 is much better. | Change from baseline in Patient global impression of change at each intervention day and at four weeks of intervention and 1 month of follow-up. | 
| Central Sensitization | Evaluation of Central Sensitization using Central Sensitization Inventory (CSI).The questionnaire is divided into two parts, the first with a score from 0 to 100 measures 25 somatic and emotional symptoms, while the second part relates to specific previous diagnoses. | Change from baseline of central sensitization at four weeks after intervention and 1 month of follow-up. | 
| Adverse events | Patient perception of any adverse event during the intervention protocol. | Up to 4 weeks of intervention and 1 month of follow-up. | 
| Use of medications | Patient declaration of medication use. | Up to 4 weeks of intervention and 1 month of follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Direct Current Stimulation, Low back pain, Exercise, Chronic pain, Combined modality therapy, Motor cortex