Effects of galvanic vestibular stimulation versus cervical proprioception training on pain, pressure pain sensitivity, and joint position sense in patients with chronic neck pain: study protocol for a randomized controlled trial

Abstract

Background and objectives: Neck pain is a disabling condition associated with pain and proprioceptive disturbances. There is limited evidence on the efficacy of treatments for chronic neck pain (CNP). The aim of this study is to conduct a randomized, controlled trial to compare the effect of galvanic vestibular stimulation (GVS) with that of cervical proprioception training (CPT) on pain and proprioception acuity in patients with chronic neck pain. Subjects and methods: Forty-eight patients with CNP enrolled in this prospective, single-blind, randomized, controlled study will be randomly allocated to one of four groups: GVS, CPT, GVS + CPT, and control. The GVS group will receive galvanic stimulation, three sessions per week, for 6 weeks. The CPT group will perform proprioceptive exercises daily for 6 weeks. The GVS + CPT group will receive both interventions. The control group will have no intervention for 6 weeks, but 6 weeks later, they will receive physical therapy. In addition, 12 healthy subjects will be recruited. This study protocol has been approved by the Ethics Review Board of Iran University of Medical Sciences, with permission number IR.IUMS.REC 1395.9211342210 on August 8, 2016. Patient recruitment began in October 2016 and ended in October 2018. Data analysis will be performed in March 2019 and the study will be completed in May 2019. Outcome measures: The primary outcome measures will be intensity of pain, pressure pain threshold, and joint position error. The secondary outcome measures will be disability and health-related quality of life. Outcomes will be assessed at baseline and at the end of sessions 1 and 18. Discussion: Findings from the trial are expected to help assess the effectiveness of GVS, compared with CPT in patients with CNP. If this protocol is proven to be effective, it can be implemented in a clinical setting to manage chronic pain in patients with CNP. We expect this study to offer information about the positive effects of GVS and CPT. Findings from this study will be helpful in progressing GVS from science to practice and in managing disturbances in CNP. Trial registration: The study was registered at the Iranian Registry of Clinical Trials on September 26, 2016 (IRCT2016060121459N2).