Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain

NCT ID: NCT05467566

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-12-31

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%.

Conditions

Low Back Pain; Transcranial Direct Current Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Stimulation + exercise group

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

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

Exercise protocol + application of active direct current stimulation for 30 minutes.

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.

Group Type: SHAM_COMPARATOR

Sham Transcranial direct current stimulation

Intervention Type: DEVICE

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.

Interventions

Transcranial direct current stimulation

Exercise protocol + application of active direct current stimulation for 30 minutes.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Liane de Brito Macedo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Liane B Macedo, PhD

Role: CONTACT

liane.macedo@ufrn.br

+55 (84) 3342-2287

References

da Silva AAC, Gomes SRA, do Nascimento RM, Fonseca AK, Pegado R, Souza CG, Macedo LB. Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol. BMJ Open. 2023 Dec 30;13(12):e075373. doi: 10.1136/bmjopen-2023-075373.

Reference Type: DERIVED

PMID: 38159941 (View on PubMed)

Other Identifiers

LBPETCC22

Identifier Type: -

Identifier Source: org_study_id