Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07178496 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Sleep Hygiene Plus Physiotherapy for Sleep and Disability in Chronic Neck Pain

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified Show 8 more changesShow less
    • Completed without a posted recruiting period
    • Final enrollment: 99 participants (planned 120)
    • Primary completion date changed from estimate of Apr 1, 2026 to Aug 1, 2026
    • Study sites: 0 to 1
    • Study completion date changed from estimate of May 2, 2026 to Aug 2, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (2)
    • Publications: details revised at 1 of 1 entry
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study investigates the effectiveness of a combined intervention that integrates sleep hygiene education with physiotherapy exercises in patients suffering from chronic neck pain. Chronic neck pain is often associated with both musculoskeletal dysfunction and secondary sleep disturbances, which in turn may exacerbate pain perception, fatigue, and disability. Traditional physiotherapy exercise programs focus primarily on improving cervical mobility, muscle strength, and postural control, but they do not typically address sleep-related problems that can hinder recovery. The intervention in this study consists of two main components: Physiotherapy Exercise Program - A structured regimen targeting cervical spine mobility, deep cervical flexor strengthening, scapular stabilization, and postural correction. These exercises aim to reduce pain, restore function, and improve overall physical performance. Sleep Hygiene Education - A structured educational module covering principles of healthy sleep habits, including maintaining consistent sleep-wake schedules, creating an optimal sleep environment, limiting stimulants before bedtime, and adopting relaxation strategies to promote better sleep initiation and maintenance. By combining these approaches, the intervention addresses not only the physical impairments associated with chronic neck pain but also the psychosocial and behavioral factors contributing to poor sleep quality. Outcome Measures: Primary Outcomes: Sleep quality, assessed using validated tools such as the Pittsburgh Sleep Quality Index (PSQI). Secondary Outcomes: Disability and functional limitations, measured by the Neck Disability Index (NDI), along with pain intensity assessed using a Visual Analog Scale (VAS). Fatigue will be assessed by fatigue inventory index Study Hypothesis: The combined intervention of sleep hygiene education and physiotherapy exercise will lead to greater improvements in sleep quality and reductions in disability and fatigue compared to physiotherapy exercise alone. Clinical Significance: If effective, this integrative approach may provide a cost-effective, non-pharmacological management strategy for patients with chronic neck pain, targeting both physical and behavioral contributors to their condition.
Trial Details
NCT Number NCT07178496
Lead Sponsor Al-Azhar University
Conditions
(from sponsor)
Neck Pain, Neck Pain Musculoskeletal, Sleep Disturbances, Fatigue, Mental
Related terms Mental Fatigue, Neck Pain, Parasomnias, Sleep Hygiene
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov