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Neck PainNCT07178496

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

A study testing Sleep Hygiene Techniques and conventional physiotherapy program in people with Neck Pain and Neck Pain Musculoskeletal, run by Al-Azhar University at 1 site in Palestinian Territories.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the effectiveness of a combined intervention that integrates sleep hygiene education with physiotherapy exercises in patients suffering from chronic neck pain. Read more about this study

Who is it for?
Ages 25 to 55 yearsHealthy volunteers can take part
What is being tested?
Sleep Hygiene Techniques and conventional physiotherapy program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 sitePalestinian Territories
Study dates
15 Oct 2025to 2 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants will be eligible for the study if they meet the following conditions:
  • Adults aged 25-55 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Palestinian Territories1 site
  • Naser medical complex

    Gaza

Other trials in Palestinian Territories

About this study

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

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:

Read more

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.

Being tested
Sleep Hygiene Techniques, conventional physiotherapy program, Control arm
Keywords
sleep quaity, sleep hygiene, neck pain
Medical subject headings
Neck Pain, Parasomnias, Mental Fatigue, Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep Hygiene TechniquesOther

    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 programOther

    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)
  • Control armOther

    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

Study groups in NCT07178496
Study groupRoleWhat they receive
Group receive conventional Physiotherapy programExperimentalConventional 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)
Receives: Other: conventional physiotherapy program
Group receive conventional Physiotherapy program plus sleep hygiene techniqueExperimentalExercise 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
Receives: Other: Sleep Hygiene Techniques
controlOtheradvices and home program
Receives: Other: Control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: pre and 8 weeks post interventions as well as 8 weeks follow up

  2. 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.

    Measured: Pre, 8 weeks post PT intervention's and 8 weeks follow up

Secondary outcomes (2)
  1. 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.

    Measured: Pre, 8 weeks post PT and 8 weeks follow up

  2. 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.

    Measured: Pre, 8 weeks post PT interventions, and 8 weeks follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start15 Oct 2025
  3. Primary completion1 Aug 2026
  4. Study completion2 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178496
Sponsor's protocol ID
AL Azhar university, GAZA STRI
Status last verified
Sep 2026
First submitted
27 Aug 2025
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 36731933

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Hygiene Techniques and conventional physiotherapy program in people with Neck Pain and Neck Pain Musculoskeletal, run by Al-Azhar University at 1 site in Palestinian Territories.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSQI to assess sleep quality (time frame: pre and 8 weeks post interventions as well as 8 weeks follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07178496, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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Clinical Trial NCT07178496 | AzTrials