Clinical trial NCT05467566: Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain
Official title: The Effects of Transcranial Direct Current Stimulation Combined With Pilates Based Exercise in the Treatment of Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Transcranial Direct Current Stimulation
Keywords: Transcranial Direct Current Stimulation
Low back pain
Exercise
Chronic pain
Combined modality therapy
Motor cortex
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up
measure: Functional performance associated to back pain
timeFrame: Change from baseline in functional performance at four weeks after intervention and 1 month of follow-up
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Change from baseline in pressure pain threshold at four weeks after intervention and 1 month of follow-up
measure: Individual quality of life
timeFrame: Change from baseline in quality of life questionnaires at four weeks after intervention and 1 month of follow-up
measure: Patient global impression of change
timeFrame: 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.
measure: Central Sensitization
timeFrame: Change from baseline of central sensitization at four weeks after intervention and 1 month of follow-up.
measure: Adverse events
timeFrame: Up to 4 weeks of intervention and 1 month of follow-up.
measure: Use of medications
timeFrame: Up to 4 weeks of intervention and 1 month of follow-up.
Other outcomes:
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