Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Transcranial Direct Current Stimulation
• Intervention / Treatment: Device: Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stimulation + exercise group; 30-minute exercise program (based on Pilates method) combined with active transcranial direct current stimulation.	Device: Transcranial direct current stimulation; Exercise protocol + application of active direct current stimulation for 30 minutes.
SHAM_COMPARATOR: Sham stimulation + exercise group; 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; 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.

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.

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Low back pain; Chronic pain; Transcranial Direct Current Stimulation; Motor cortex; Combined modality therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LBPETCC22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No