Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain
Study Details
Study Description
Brief Summary
This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Considered a public health problem, low back pain is globally presented as a symptomatology of high prevalence, incidence and recurrence. In addition, it is responsible for a large part of disabilities, reduced functional performance, absences from work and impaired quality of life, which brings biopsychosocial impacts to the affected subjects. 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 associated with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of 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, performance, pressure pain threshold, 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stimulation and exercise group 30-minute exercise program (based on Pilates method) associated with active transcranial direct current stimulation. |
Other: Stimulation and exercise group
Exercise protocol + application of active direct current stimulation for 30 minutes.
|
| Sham Comparator: Exercise and sham stimulation group 30-minute exercise program (based on Pilates method) associated with sham transcranial direct current stimulation. |
Other: Exercise and sham stimulation group
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.
|
Outcome Measures
Primary Outcome Measures
- Pain intensity (numerical pain rating scale) [up to 1 month of follow-up]
Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.
Secondary Outcome Measures
- Pressure pain threshold [A pressure pain four weeks after intervention and 1 month of follow-up]
Pressure pain threshold measured by pressure algometer.
- Root Mean Square (RMS) [Evaluation of RMS four weeks after intervention and 1 month of follow-up]
Analyze of the electromyographic activity of the back muscles
- Peak of muscular torque [Evaluation of Peak of muscular torque four weeks after intervention and 1 month of follow-up]
Evaluate the peak of muscular torque using the hand-held dynamometer.
- Back muscle fatigue [Evaluation of Back muscle fatigue four weeks after intervention and 1 month of follow-up]
Measure the back muscular resistance to fatigue using the Ito test
Eligibility Criteria
Criteria
Inclusion Criteria:
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:
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diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
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low cognitive level assessed by the Mini Mental State Examination;
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presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
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history of epileptic illness;
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seizure history;
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brain implants;
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pacemaker;
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pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Universidade Federal do Rio Grande do Norte
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SRAG2022