Randomized Controlled Trial to Investigate Efficacy of a Novel Neck Orthosis for Pain Caused by Forward Head Posture in Active-Duty Military Members- ACRM 2025
N Hogaboom, m Smith, v morris, m st. laurent, x yuan, m nordstrom
Abstracted accepted for a poster presentation at the 2025 American Congress of Rehabilitation Medicine Annual Fall Conference
Neck pain is a significant problem among active-duty Service Members (ADSMs). A neck orthosis was designed as a minimally invasive device to correct forward head posture (FHP) and reduce associated neck pain. The primary study objective was to investigate the efficacy of the neck orthosis to reduce pain and improve function. Secondary objectives included evaluation of safety and treatment protocol adherence.
Participants were randomized into either immediate treatment (IT) or waitlist-control (WC) groups. Participants in the IT group received the collar and were instructed to wear it 20 minutes daily for 6 consecutive weeks. Those in the WC group continued with standard of care (SOC) treatment during first 6 weeks of study participation.
Thirty-five individuals completed the protocol (treatment n=18, control n=17). Changes in NPRS (U=259.5, p<.001, r=0.59) and NDI (U=89.5, p<.05, r=0.36) scores were significantly different between IT and WC groups. Post analyses revealed a significant main effect of time on NPRS in the IT group. Decreases of 2.0 points were observed (p<.001, r=.64), which surpassed the minimal clinically important difference of 1.3. No changes were observed in the WC group. No main effects of time on NDI were reported in either group (p>.05). Thirteen participants reported full adherence to the protocol (72.2%). Those who did not fully adhere to the protocol reported an average of 4.0±2.8 days of usage per week for 15.0±8.9 minutes per day. No serious AEs related to the protocol were reported.
The treatment protocol, which involved daily usage of the neck orthosis for six consecutive weeks, was safe and resulted in marked decreases in pain compared to a control group who received SOC treatment for neck pain. Improvements in function were observed, but these changes were not significant. Efforts should be made to improve adherence, as it is unclear how it impacted outcomes.