Efficacy of the addition of interferential current to Pilates method in patients with low back pain: a protocol of a randomized controlled trial
BACKGROUND
Chronic low back pain is one of the four most common diseases in the world with great socioeconomic impact. Supervised exercise therapy is one of the treatments suggested for this condition; however, the recommendation on the best type of exercise is still unclear. The Pilates method of exercise is effective in reducing pain and disability in these patients, as well as the analgesia promoted by interferential current. Currently, the literature lacks information on the efficacy of the association of these two techniques in the short- and medium-term than performing one of the techniques isolated. The objective of this study will be to evaluate the efficacy of adding interferential current to the Pilates method exercises for the treatment of patients with chronic nonspecific low back pain in the short- and medium-term.


METHODS/DESIGN
This study will be a randomized controlled trial with two arms and blinded evaluator, conducted at an outpatient Physical Therapy Department in Brazil. Patients with nonspecific chronic low back pain and pain equal to or greater than 3 in the Pain Numerical Rating Scale (0/10) will be randomly assigned to one of two groups: Group with active interferential current + Pilates (n = 74) will be submitted to the active interferential current associated to the modified Pilates exercises, and Group with sham interferential current + Pilates (n = 74) will be submitted to the sham interferential current associated with the modified Pilates exercises during 18 sessions. The outcomes pain intensity, pressure pain threshold, general and specific disability, global perceived effect and kinesiophobia will be evaluated by a blinded assessor at baseline, six weeks and six months after randomization.


DISCUSSION
Because of the study design, blinding of the participants and the therapists involved in the study will not be possible. The results of this study could contribute to the process of clinical decision- making for the improvement of pain and disability in participants with nonspecific chronic low back pain.


TRIAL REGISTRATION
ClinicalTrials.gov NCT01919268.