Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant)

INTRODUCTION: Chronic neck pain is a common musculoskeletal disorder that is associated with functional disability and decreased of quality of life. Electrophysical agents are commonly used to relieve pain, however the effects of combined use of these agents are little studied. The objective is to investigate the efficacy of photobiomodulation and electrical stimulation to relieve pain, both in isolation and combined. MATERIALS AND METHODS: This a 4-arm randomized placebo-controlled trial with patient and evaluator blinded. This study will be performed in Department of Physical Therapy at Federal University of São Carlos, São Carlos/SP, Brazil. One hundred and forty-four patients with chronic neck pain will be randomized into 4 groups: active photobiomodulation therapy with active electrical stimulation, active photobiomodulation therapy, active electrical stimulation, or placebo treatment. They will receive 10 sessions of treatment. Primary outcome: pain intensity (measured by pain numerical rating scale) posttreatment. Secondary outcomes: pain during movement, neck disability, range of motion, pressure pain threshold, temporal summation, conditioned pain modulation, depressive symptoms, pain catastrophizing, quality of life, analgesic intake, and global perceived effect at posttreatment (10 sessions). Pain intensity and global perceived effect will also be measured after 6 weeks randomization. DISCUSSION: The findings of this study might clarify the importance of using the photobiomodulation therapy and transcutaneous electrical nerve stimulation for patients with chronic neck pain. TRIAL REGISTRATION: NCT04020861. https://clinicaltrials.gov/ct2/show/NCT04020861?term=NCT04020861&draw=2&rank=1.