Capacitively coupled electric field for pain relief in patients with vertebral fractures and chronic pain.

UNLABELLED: Fragility vertebral fractures often are associated with chronic back pain controlled by analgesic compounds. Capacitive coupling electrical stimulation is a type of electrical stimulation technology approved by the US FDA to noninvasively enhance fracture repair and spinal fusion. These uses suggest it would be a possible treatment for patients with back pain attributable to vertebral fractures. We therefore randomized 51 postmenopausal women with multiple fractures and chronic pain to the use of one of two indistinguishable devices delivering either the standard capacitive coupling electrical stimulation by Osteospine (active group) or low intensity pulse (control group). Twenty patients of the active group and 21 of the control group (80%) completed the study for a total duration of 3 months. The mean visual analog scale values for pain and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) scores improved in both groups. We observed a relationship between hours of treatments and reductions in pain intensity only in the active group. Capacitive coupling electrical stimulation was not more effective than control treatment when comparing mean visual analog scale pain and QALEFFO scores in the two groups and when adjusting for the hours of treatment. However, the proportion of patients able to discontinue NSAIDs owing to elimination or reduction of pain was greater in the active group than in the control group. We interpret these findings as suggesting capacitive coupling electrical stimulation controls pain in some patients and reduces the use of NSAIDs. LEVEL OF EVIDENCE: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

RCT Entities:   Population Interventions Outcomes