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.

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.

DIAM device for low back pain in degenerative disc disease : 24 months follow-up.

PURPOSE: To evaluate the usefulness of the DIAM device in patients affected by low back pain due to degenerative disc disease. BACKGROUND: Recently a number of interspinous devices for dynamic interspinous distraction-stabilization have entered the clinical practice in Europe. All of these devices have a common property of acting on the posterior part of the functional spinal unit by distracting the spinous processes and avoiding extension of the treated segment. Consequently, these systems seem to improve the cross-sectional area of the thecal sac and enlarge the diameter of the intervertebral foramina. What was found as a collateral observation after implantation of these devices was that those patients affected by low back pain, improved significantly in their pain level. METHODS AND MATERIALS: Fifty-two consecutive patients were included in the study. There were 29 females and 23 males, aged between 29 and 77 years (mean 49.4 ± s.d. 12.4). The pre-operative symptom duration ranged from 6 to 84 months (mean 31.8 ± s.d. 20.2, median 24 months).The following diagnostic measures were performed in each patient: MRI, dynamic X-rays and provocative discography positive for pain reproduction.The patients were followed for pain by VAS and for functional status by self-reported Roland-Morris Disability Questionnaire. The minimum follow-up was 24 months (24-36). The intermediate follow-up at 6, 12 and 18 months was tested for, too. RESULTS: To determine the number of improved patients we have arbitrarily selected a cut-off criteria based on a ≥30% of improvement as calculated on the Roland Morris Disability Questionnaire scale comparing the 24 months values to the baseline values. Forty-six patients (88%) were considered as success and 2 (4%) were considered as failure. No long-term complications were observed. CONCLUSIONS: This preliminary report indicates that the DIAM device could possibly be useful in the treatment of LBP due to DDD. Further research with RCT is necessary to confirm these preliminary results.

Intramuscular thrombosed arteriovenous hemangioma of the upper right arm mimicking a neuroma of the ulnar nerve: case report.

OBJECTIVE AND IMPORTANCE: Soft tissue arteriovenous hemangiomas (AHs) are benign vascular hamartomas characterized by the presence of arteriovenous shunts. Few cases of soft tissue AHs have been found in the literature, and these were frequently described as cutaneous lesions of the limb or of the scalp. Intramuscular AHs are extremely rare. AHs are prevalent in children and women and are often associated with other types of malformations or genetic disorders. We present the case of an elderly woman with an intramuscular thrombosed AH on the volar side of the upper right arm. Owing to the close proximity of the ulnar nerve, this lesion was initially identified as a neuroma. CLINICAL PRESENTATION: A 70-year-old woman presented with a short history (a few months) of progressive growth of a nonpulsating, solid, palpable mass deeply localized in the distal third of the right upper arm. At the neurological examination, local evoked pain was the only sign detected. A Doppler ultrasound examination depicted a hyperechoic spherical lesion with widespread calcium deposits and necrosis. INTERVENTION: The exploration of the upper arm revealed a capsulated nodular lesion, 7 cm in diameter, that morphologically corresponded to a thrombosed vascular lesion. This lesion was removed en bloc, and an unequivocal connection with a muscular branch of the ulnar artery was detected. The histological analysis revealed AH. CONCLUSION: Intramuscular AHs are rare and may easily be misdiagnosed as neuromas, especially when they are contiguous to a peripheral nerve.