Objective: To determine the effectiveness (at the 0.1 level of statistical significance) of the Align-Right (roll-shaped) cervical pillow (ARCP) on neck pain severity and headache/neck pain medication use in chronic neck pain subjects.
Design: The design was a "before/after" (i.e., a "pre/post" trial).
Subjects: Twenty-eight subjects, 25-45 yr of age with cervical spine pain of biomechanical origin of > 2 on an 11-point ordinal pain scale.
Outcome measures: The primary outcome measure was severity of morning and evening neck pain. The secondary outcome measure was daily quantity of analgesics ingested. The data were analyzed descriptively and inferentially for clinically and statistically significant pre/post intervention differences.
Methods: Eligible subjects who successfully finished a 2-wk baseline data-gathering period by mailing in two properly completed diaries each received a pillow and four more diaries (to be filled in over the subsequent 4 wk). Three repeated-measures analyses of variance were performed using the Bonferroni-corrected level of statistical significance of 0.03. Ninety-five percent confidence intervals (for paired-samples mean differences) were also calculated for those pre/post differences that seemed descriptively clinically important.
Results: The clinically and statistically significant reductions in neck/shoulder pain severity in this sample of chronic neck pain subjects suggest that the ARCP is an effective therapy for target populations with the same profile as this sample. Patient characteristics predicting suitability were not studied in this project.
Conclusion: The results suggest that the ARCP has clinically important beneficial effects on the neck pain severity of most chronic neck-pain sufferers. Further randomized clinical trial research comparing the ARCP with other commonly used cervical pillows is recommended.