Randomized Feasibility Pilot Trial of Adding a New Three-Dimensional Adjustable Posture-Corrective Orthotic to a Multi-Modal Program for the Treatment of Nonspecific Neck Pain

Abstract

The aim of this study was to investigate the feasibility and effect of a multimodal program for the management of chronic nonspecific neck pain CNSNP with the addition of a 3D adjustable posture corrective orthotic (PCO), with a focus on patient recruitment and retention. This report describes a prospective, randomized controlled pilot study with twenty-four participants with CNSNP and definite 3D postural deviations who were randomly assigned to control and study groups. Both groups received the same multimodal program; additionally, the study group received a 3D PCO to perform mirror image® therapy for 20–30 min while the patient was walking on a treadmill 2–3 times per week for 10 weeks. Primary outcomes included feasibility, recruitment, adherence, safety, and sample size calculation. Secondary outcomes included neck pain intensity by numeric pain rating scale (NPRS), neck disability index (NDI), active cervical ROM, and 3D posture parameters of the head in relation to the thoracic region. Measures were assessed at baseline and after 10 weeks of intervention. Overall, 54 participants were screened for eligibility, and 24 (100%) were enrolled for study participation. Three participants (12.5%) were lost to reassessment before finishing 10 weeks of treatment. The between-group mean differences in change scores indicated greater improvements in the study group receiving the new PCO intervention. Using an effect size of 0.797, α > 0.05, β = 80% between-group improvements for NDI identified that 42 participants were required for a full-scale RCT. This pilot study demonstrated the feasibility of recruitment, compliance, and safety for the treatment of CNSNP using a 3D PCO to a multimodal program to positively affect CNSNP management.