Tapentadol extended release for the management of chronic neck pain

Abstract

Background: The role of opioids in the management of chronic neck pain is still poorly investigated. No data are available on tapentadol extended release (ER). In this article, we present 54 patients with moderate-to-severe chronic neck pain treated with tapentadol ER.

Patients and methods: Patients received tapentadol ER 100 mg/day; dosage was then adjusted according to clinical needs. The following parameters were recorded: pain; Douleur Neuropathique 4 score; Neck Disability Index score; range of motion; pain-associated sleep interference; quality of life (Short Form [36] Health Survey); Patient Global Impression of Change (PGIC); Clinician GIC; opioid-related adverse effects; and need for other analgesics.

Results: A total of 44 of 54 patients completed the 12-week observation. Tapentadol ER daily doses increased from 100 mg/day to a mean (standard deviation) dosage of 204.5 (102.8) mg/day at the final evaluation. Mean pain intensity at movement significantly decreased from baseline (8.1 [1.1]) to all time points (P<0.01). At baseline, 70% of patients presented a positive neuropathic component. This percentage dropped to 23% after 12 weeks. Tapentadol improved Neck Disability Index scores from 55.6 (18.6) at baseline to 19.7 (20.9) at the final evaluation (P<0.01). Tapentadol significantly improved neck range of motion in all three planes of motion, particularly in lateral flexion. Quality of life significantly improved in all Short Form (36) Health Survey subscales (P<0.01) and in both physical and mental status (P<0.01). Based on PGIC results, approximately 90% of patients rated their overall condition as much/very much improved. Tapentadol was well tolerated: no patients discontinued due to side effects. The use of other analgesics was reduced during the observed period.

Conclusion: Our results suggest that tapentadol ER, started at 100 mg/day, is effective and well tolerated in patients with moderate-to-severe chronic neck pain, including opioid-naïve subjects. Patients can expect a decrease in pain, an improvement in neck function, and a decrease in neuropathic symptoms.

Keywords: Neck Disability Index; chronic neck pain; neuropathic pain; opioids; range of motion; tapentadol.

Figure 1

Mean and SD pain intensity (11-point NRS) over time (observed-case analysis) at rest and on movement. Abbreviations: SD, standard deviation; NRS, numeric rating scale.

Figure 2

Percentage of patients with neuropathic pain 4 score ≥4 from baseline to week 12 (final evaluation).

Figure 3

Neck Disability Index (NDI; mean and SD) from baseline to week 12 (final evaluation). Notes: 55.6% (SD 18.6) at baseline; 44.4% (SD 24.1) at week 1; 38.2% (SD 25.9) at week 2; 31.1% (SD 25.2) at week 4; 25.1% (SD 23.2) at week 8; 19.7% (SD 20.9) at week 12. Abbreviation: SD, standard deviation.

Figure 4

Percentage of neck ROM variation from baseline to week 12 (final evaluation). Abbreviation: ROM, range of motion.

Figure 5

SF-36 physical and mental health and total score from baseline to week 12 (final evaluation). Note: **P<0.01 baseline–final improvement, paired t-test. Abbreviation: SF-36, Short Form (36) Health Survey.

Figure 6

SF-36 scores from baseline to week 12 (final evaluation). Note: **P<0.01 baseline–final improvement, paired t-test. Abbreviation: SF-36, Short Form (36) Health Survey.