Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain

Universidade Federal do Rio Grande do Norte

Status: Not yet enrolling

Conditions: Transcranial Direct Current Stimulation; Low Back Pain

Treatments: Device: Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05467566

LBPETCC22

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Stimulation + exercise group

Experimental group

Description:

30-minute exercise program (based on Pilates method) combined with active transcranial direct current stimulation.

Treatment:

Device: Transcranial direct current stimulation

Sham stimulation + exercise group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial direct current stimulation