An interventional study of Sleep Hygiene Techniques and conventional physiotherapy program in Neck Pain, Neck Pain Musculoskeletal and Sleep Disturbances, sponsored by Al-Azhar University. Completed at 1 site in Palestinian Territories. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's enrollment of 99 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will be eligible for the study if they meet the following conditions:
Exclusion Criteria
Participants will be excluded if any of the following conditions are present:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Other: conventional physiotherapy program
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
Other: Sleep Hygiene Techniques
advices and home program
Other: Control arm
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 cervical alignment and reduce neck strain. Remove distractions such as TVs, mobile phones, and bright lights. Pre-Sleep Routine Establish a relaxing wind-down routine (e.g., gentle stretching, breathing exercises, reading). Avoid mentally stimulating activities or heavy problem-solving before bedtime. Limiting Stimulants and Alcohol Avoid caffeine, nicotine, and alcohol at least 4-6 hours before bedtime. Avoid heavy meals close to bedtime; a light snack is acceptable if hungry. Daytime Habits t
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 Endurance and Strength Training (30-40 minutes)
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 shoulders. Small posture corrections throughout the day prevent stiffness. Use Heat Before Exercise if Stiff or Painful Apply a hot pack for 10-15 minutes before exercises to relax muscles. Avoid prolonged or excessive heat application. Stay Active - Avoid Prolonged Rest Light physical activity (walking, cycling, gentle mobility work) helps recovery. Bed rest should be avoided unless pain is severe. Practice Relaxation and Breathing C
PSQI to assess sleep quality
Pittsburgh Sleep Quality Index (PSQI): The PSQI is a widely used and validated self-reported questionnaire designed to assess sleep quality and disturbances over a 1-month period. It consists of 19 individual items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a 0-3 scale, and the sum of these components yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 is typically used to distinguish poor sleepers from good sleepers. The PSQI provides a comprehensive overview of both qualitative and quantitative aspects of sleep, making it a suitable primary outcome measure in this study.
Time frame: pre and 8 weeks post interventions as well as 8 weeks follow up
NDI to assess Disability related to neck pain
Neck Disability Index (NDI): The NDI is a standardized, condition-specific outcome measure used to determine the level of disability in individuals with neck pain. It contains 10 items addressing pain intensity and the impact of neck pain on daily activities such as personal care, lifting, reading, concentration, work, driving, sleeping, and recreation. Each item is scored on a 0-5 scale, with the total score ranging from 0 to 50, which can then be expressed as a percentage. Higher scores reflect greater disability. The NDI is recognized as a reliable and valid tool for evaluating functional limitations and tracking treatment progress in patients with chronic neck pain.
Time frame: Pre, 8 weeks post PT intervention's and 8 weeks follow up
VAS to assess Pain
Visual Analog Scale (VAS) for Pain: The VAS is a simple, validated tool used to measure pain intensity. It typically consists of a 10-centimeter horizontal line, with the left end representing "no pain" and the right end representing "worst imaginable pain." Patients are asked to mark a point along the line that best represents their perceived pain intensity at the time of assessment. The score is determined by measuring the distance in centimeters from the left end of the line to the patient's mark, yielding a score between 0 and 10. The VAS is highly sensitive to changes in pain over time and is widely used in clinical and research settings to evaluate treatment effectiveness.
Time frame: Pre, 8 weeks post PT and 8 weeks follow up
FSS to assess Fatigue
Fatigue Severity Scale (FSS): The Fatigue Severity Scale is a self-reported questionnaire designed to assess the severity and impact of fatigue on daily functioning. It consists of nine statements that evaluate how fatigue interferes with motivation, exercise, physical functioning, and social life. Each statement is rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). The mean of all item scores is calculated, with higher scores indicating greater fatigue severity. The FSS is a reliable and valid measure, particularly relevant in chronic pain populations, as fatigue is a common and often overlooked symptom that contributes significantly to reduced quality of life.
Time frame: Pre, 8 weeks post PT interventions, and 8 weeks follow up
Plan to share: Undecided
Ran from Oct 2025 to primary completion in Aug 2026, 9 months.
Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 9 months is above that.
Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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