Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effects of Transcranial Direct Current Stimulation Associated With Pilates Based Exercise in Performance of Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05651763
• Other study ID #: SRAG2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Jamilson S Brasileiro, PhD
• Phone: +55 84 3342-2008
• Email: brasileiro[@]ufrnet.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Transcranial Direct Current Stimulation

Intervention

Other:
• Stimulation and exercise group
Exercise protocol + application of active direct current stimulation for 30 minutes.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity (numerical pain rating scale)	Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.	up to 1 month of follow-up
Secondary	Pressure pain threshold	Pressure pain threshold measured by pressure algometer.	A pressure pain four weeks after intervention and 1 month of follow-up
Secondary	Root Mean Square (RMS)	Analyze of the electromyographic activity of the back muscles	Evaluation of RMS four weeks after intervention and 1 month of follow-up
Secondary	Peak of muscular torque	Evaluate the peak of muscular torque using the hand-held dynamometer.	Evaluation of Peak of muscular torque four weeks after intervention and 1 month of follow-up
Secondary	Back muscle fatigue	Measure the back muscular resistance to fatigue using the Ito test	Evaluation of Back muscle fatigue four weeks after intervention and 1 month of follow-up