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

Al-Azhar University

Status: Not yet enrolling

Conditions: Fatigue, Mental; Neck Pain Musculoskeletal; Neck Pain; Sleep Disturbances

Treatments: Other: conventional physiotherapy program; Other: Sleep Hygiene Techniques; Other: Control arm

Study type: Interventional

Funder types: Other

Identifiers

NCT07178496

AL Azhar university, GAZA STRI

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

1. History of cervical spine trauma, surgery, or fracture within the past 6 months.
2. Severe depression or anxiety, defined by scores above the severe threshold on the Hospital Anxiety and Depression Scale (HADS).
3. Neurological disorders affecting neck function (e.g., cervical radiculopathy, myelopathy).
4. Other musculoskeletal disorders causing significant neck or shoulder pain.
5. Sleep disorders unrelated to neck pain (e.g., obstructive sleep apnea, restless legs syndrome, narcolepsy), whether diagnosed or suspected.
6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Group receive conventional Physiotherapy program

Experimental group

Description:

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. Neck Endurance and Strength Training (30-40 minutes)

Treatment:

Other: conventional physiotherapy program

Group receive conventional Physiotherapy program plus sleep hygiene technique

Experimental group

Description:

Exercise and 1. Delivery Method Initial Education Session: A 45-minute one-on-one session with a physiotherapist or trained researcher. Delivered face-to-face using visual aids (slides, posters, printed guide). Explains what sleep hygiene is, why it matters in chronic neck pain, and how to apply each strategy. Follow-up Sessions: Weekly 15-20-minute reinforcement sessions (in-person or by phone/video call). Used to review progress, clarify doubts, troubleshoot barriers, and adjust advice if necessary. Written Materials: A patient booklet summarizing all recommendations in simple language, including diagrams of neck-friendly sleeping postures. A daily sleep diary to track bedtime, wake time, naps, and perceived sleep quality. 2. Program Content A. Regular Sleep-Wake Timing Go to bed at the same time every night and wake at the same time every morning, even on weekends. Use alarms only for waking, not for forcing sleep onset. Limit naps to \<30 minutes, no later than 4

Treatment:

Other: Sleep Hygiene Techniques

control

Other group

Description:

advices and home program

Treatment:

Other: Control arm