Does the Pillow Affect the Sleep Quality and Disability in Patients With Cervical Spondylosis? A Study Protocol for a Randomized Clinical Trial.

Background and purpose: Cervical spondylosis significantly impacts disability and sleep quality. Along with physiotherapy, selecting an appropriate pillow may improve spinal alignment, relieve neck strain, and enhance sleep. This study protocol aims to evaluate the effectiveness of different pillows in managing cervical spondylosis.

Methods: A participant-blinded, three-arm parallel pilot randomized clinical trial will be conducted at a super-speciality tertiary care hospital. Participants with cervical spondylosis will be randomized into three groups: Group 1 (Cervical pillow + Physiotherapy), Group 2 (Regular pillow + Physiotherapy), and Group 3 (Physiotherapy only). Physiotherapy sessions will include moist heat packs, sub-occipital release, TENS, and postural re-education exercises, delivered three times a week for 4 weeks. Outcome measures-Pittsburgh Sleep Quality Index, Neck Disability Index, Numerical Pain Rating Scale, and Range of Motion-will be assessed at baseline and after 4 weeks.

Results: Descriptive and inferential statistical analyses will be performed on the data. Depending on the results of the normality test, either parametric or non-parametric methods will be utilised for both within-group and between-group analyses.

Discussion: This study adopts a patient-centred approach, aiming to enhance understanding of the complex interplay between sleep, musculoskeletal health, and pillow selection in individuals suffering from cervical spondylosis.

Trial registration: Clinical Trials Registry of India (CTRI) with trial registration number CTRI/2024/04/065295.