title: Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series.
abstract: Patients with low back pain (LBP) suffer chronic disability. In 40% of LBP patients degenerative disc disease (DDD) seems to be the cause. This prospective case series assessed the efficacy of the interspinous device for intervertebral assisted motion (DIAM™) in patients with LBP resulting from DDD. All patients were initially assessed by physical examinations, magnetic resonance imaging, dynamic X-rays and provocative discography. Eligible patients (n = 52) had LBP for a minimum of 4 months, and received surgery with the DIAM™ system 2-4 weeks after diagnosis. Patients were evaluated pre-/post-operatively for pain severity using a visual analogue scale (VAS), and for dysfunction and disability with the Roland-Morris Disability Questionnaire (RMDQ). VAS and RMDQ score changes were assessed using the appropriate contrasts and Bonferroni-corrected P values. As a result, significant (P < 0.0001) pain score reductions were observed between baseline values, and 2 (3.7, 95% CI 3.1; 4.2) and 48 (3.1, 95% CI 2.5; 3.6) months follow-up (intent-to-treat population). Disability scores were significantly (P < 0.0001) reduced between baseline and 2 (8.6, 95% CI 7.4; 9.9) and 48 (7.5, 95% CI 6.1; 8.9) months. Disability scores were similar from months 2 to 48. At 48 months, 67.3% of patients reached the minimum clinically important difference (MCID; ≥1.5-unit improvement) in VAS score and 78.9% of patients reached the MCID (≥30% improvement) in RMDQ score. No complications were associated with surgery. In conclusion, patients with LBP treated with the interspinous DIAM™ system showed significant and clinically meaningful improvements in pain and disability for up to 4 years.
authors.affiliation: Unita Funzionale di Chirurgia Spinale c.d.c. Villanova, Florence, Italy. joburic@tin.it
authors.forename: Josip
authors.initials: J
authors.lastname: Buric
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Pulidori
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D016268:Internal Fixators / Q000592:standards; D055959:Intervertebral Disc Degeneration / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D007593:Joint Instability / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008137:Longitudinal Studies; D017116:Low Back Pain / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods; D055009:Spondylosis / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*