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

Official title

Effect of Integrating Sleep Hygiene Techniques With Physiotherapy Exercise in Improving Sleep Quality and Disability in Patients With Chronic Neck Pain

Overview

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.

Interventions

• Other Sleep Hygiene Techniques
  Sleep Hygiene Techniques The sleep hygiene program includes education and behavioral strategies to promote healthier sleep patterns, delivered alongside physiotherapy exercises. Key components are: Regular Sleep-Wake Schedule Encourage patients to maintain consistent bedtime and wake-up times, even on weekends. Avoid excessive time in bed when not sleeping. Optimizing the Sleep Environment Ensure a quiet, dark, and cool bedroom (18-22°C). Use supportive pillows to maintain neutral cervica
• Other conventional physiotherapy program
  Conventional Physiotherapy Program 1. Treatment Frequency and Duration Frequency: 3 sessions per week Duration: 8 weeks Session length: 45-60 minutes 2. Hot Pack Application (10-15 minutes) Purpose: Reduce pain, improve soft-tissue extensibility, and prepare muscles for exercise. Procedure: Moist hot pack applied to the cervical region. Temperature: 40-45°C (comfortable warmth, checked to avoid burns). Duration: 10-15 minutes with adequate towel layers. 3. Neck E
• Other Control arm
  only advices and home advices Physiotherapy Advice for Patients with Neck Pain Adhere to Your Exercise Program Perform the prescribed neck strengthening and endurance exercises daily. Focus on quality over quantity-slow, controlled movements are more effective. Maintain Correct Posture During All Activities Keep your neck in a neutral position whether sitting, standing, or walking. Incorporate Frequent Micro-Breaks Every 30-45 minutes, pause to gently move and stretch your neck and shoul

Primary outcome measures

• sleep quality [Time frame: pre and 8 weeks post interventions as well as 8 weeks follow up]
• Disability [Time frame: Pre, 8 weeks post PT intervention's and 8 weeks follow up]

Secondary outcome measures (2)

• Pain [Time frame: Pre, 8 weeks post PT and 8 weeks follow up]
• Fatigue [Time frame: Pre, 8 weeks post PT interventions, and 8 weeks follow up]

Eligibility criteria

Inclusion criteria

Participants will be eligible for the study if they meet the following conditions:

• Adults aged 20-55 years.
• Clinical diagnosis of chronic neck pain, defined as symptoms persisting for more than 3 months.
• Poor sleep quality, indicated by a Pittsburgh Sleep Quality Index (PSQI) score >5.
• Willingness to participate and comply with both the physiotherapy and sleep hygiene intervention program.
• Ability to provide informed consent.

Exclusion criteria

Participants will be excluded if any of the following conditions are present:

• History of cervical spine trauma, surgery, or fracture within the past 6 months.
• Severe depression or anxiety, defined by scores above the severe threshold on the Hospital Anxiety and Depression Scale (HADS).
• Neurological disorders affecting neck function (e.g., cervical radiculopathy, myelopathy).
• Other musculoskeletal disorders causing significant neck or shoulder pain.
• Sleep disorders unrelated to neck pain (e.g., obstructive sleep apnea, restless legs syndrome, narcolepsy), whether diagnosed or suspected.
• Ongoing pharmacological treatments that may significantly affect sleep (e.g., sedatives, hypnotics), unless the patient has been on a stable dose for >3 months.

6 Uncontrolled systemic illnesses such as diabetes, cardiovascular disease, or cancer.

7 Pregnancy.

8 Participation in any recent physiotherapy program targeting neck pain within the last 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Gupta CC, Sprajcer M, Johnston-Devin C, Ferguson SA. Sleep hygiene strategies for individuals with chronic pain: a scoping review. BMJ Open. 2023 Feb 2;13(2):e060401. doi: 10.1136/bmjopen-2021-060401. PMID 36731933

Identifiers

NCT: NCT07178496 · AL Azhar university, GAZA STRI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗