Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial

Abstract

Objective Although some studies have shown the clinical benefits of therapeutic exercise in chronic nonspecific low back pain, the effect sizes are generally small to moderate and recurrence rates are high. Transcranial direct current stimulation (tDCS) has been used to modulate pain-processing systems and motor outputs and has the potential to optimize the clinical benefits of therapeutic exercise. However, evidence for this combination is still lacking. The purpose of this protocol for a randomized clinical trial is to investigate whether the combination of tDCS and therapeutic exercise is more effective in relieving pain than therapeutic exercise alone. Methods This 2-arm, randomized controlled clinical trial will take place at the Federal University of Piauí, Brazil. Sixty patients will be randomized into 2 groups to receive tDCS (real/sham) + exercise therapies for 12 sessions over a period of 4 weeks. Pain intensity, sensory and affective aspects of pain, physical functioning, kinesiophobia, and global perceived effect will be recorded before treatment and at 4 weeks, 3 months, and 6 months after randomization. Data will be collected by an examiner unaware of (blind to) the treatment allocation. Impact This trial can potentially provide important information and assist in clinical decision-making on the combined use of tDCS to optimize the clinical benefits of therapeutic exercise in patients with chronic nonspecific low back pain.

Comparison of yoga and dynamic neuromuscular stabilization exercise in chronic low back pain on magnetic resonance imaging of lumbar multifidus- protocol for a randomized controlled trial

“…Spine Consultant will label CLBP diagnosis based on International Classification of Diseases, Ninth Revision (ICD-9) or the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. Participants referred to Physiotherapy OPD from Spine Care Center will be eligible for the study to fulfill the following criteria [ [56] , [57] , [58] , [59] , [60] , [61] , [62] ].…”

“…The primary outcome measure MRI and secondary outcome MSK-USI will be recorded by a Radiologist with 20 years of experience, blinded to the allocation of treatment groups. All other Questionnaires and baseline assessments will be documented and collected from participants by a Physiotherapist with six years of experience who is unaware of trial objectives and intervention group allocation [ [56] , [57] , [58] , [59] , [60] , [61] , [62] ]. The participants will be blinded to the group they will be allocated.…”

“…The appointment of the participants will be fixed on flexible timing of the participants to promote the participant engagement in trial and adherence. The exercise pamphlet and videos will be shared with participants weekly upon the follow-up visit [ 56 , 58 ].…”

“…After resolving the issue, if a Participant wants to withdraw from the study, they are eligible to withdraw from the trial as per the Clinical Trial Practice Guideline. The study coordinator will ensure that Participants receive standard treatment care after withdrawal from the study [ 56 , 58 , 60 , 61 ]. The revoke of the consent form will be obtained from the participant.…”

Protocolos de ensaios clínicos: relevância e contribuições além da qualidade metodológica

“…E algumas revistas já estão solicitando isso aos autores. 9 Precisamos avançar rapidamente na incorporação de informações que realmente tragam contribuições relevantes para o progresso da ciência, pois outros aspectos também deverão ser abordados nos protocolos clínicos: os custos e as consequências de uma intervenção em saúde.…”