ORIGINAL ARTICLE   Free access

Minerva Ortopedica e Traumatologica 2017 March;68(1):13-9

DOI: 10.23736/S0026-4911.16.03777-0

Copyright © 2016 EDIZIONI MINERVA MEDICA

language: English

Tapentadol prolonged release in patients with severe chronic low back pain: results from a prospective, observational single-center study

Paolo NOTARO ✉

Pain Therapy Department, Niguarda Ca’ Granda Hospital, Milan, Italy

BACKGROUND: This study evaluates the efficacy and safety of tapentadol prolonged release (PR) in patients with chronic low-back pain.
METHODS: This was a 6-month, prospective, observational single-centre study of 27 patients with chronic severe low-back pain (Numeric Rating Scale [NRS] ≥5). Tapentadol PR treatment was started at 100 mg/day, and could be increased up to 500 mg/day. Main outcome measures were intensity of pain, assessed by a 11-point NRS (0-11); overall evaluation of efficacy and tolerability; health status and quality of life (QoL) of treated patients.
RESULTS: All patients (mean age 63±12 years, 88.9% suffered from low-back pain for >12 months) received analgesic drugs prior to tapentadol PR treatment. Tapentadol PR significantly reduced the average intensity of pain at rest and pain on movement: a 44% reduction in the NRS Score for pain at rest was already observed at nine days; a 27% reduction in the NRS Score for pain at movement was observed at three days since the initiation of therapy (P<0.01 for both comparisons). Neuropathic component of pain, QoL and health status improved. Tapentadol PR was well tolerated.
CONCLUSIONS: Despite the small sample size of the study should be taken into account, tapentadol PR at average dosing (200-300 mg/day) is effective in patients with chronic severe low back pain, as it allows long-term analgesic efficacy with a reduction in pain intensity and in the neuropathic component.

KEY WORDS: Low back pain - Neuralgia - Prospective studies - Tapentadol - Delayed-action preparations - Quality of life