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

NCT07178496 | Not Yet Recruiting DMC

• 1 other identifier: AL Azhar university, GAZA STRI
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

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

Keywords

sleep quaity; sleep hygiene; neck pain

Outcome Measures

Primary Outcomes (2)

• 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.

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

• Disability

  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.

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

Secondary Outcomes (2)

• Pain

  Pre, 8 weeks post PT and 8 weeks follow up

• Fatigue

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

Study Arms (3)

Group receive conventional Physiotherapy program

EXPERIMENTAL

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

Group receive conventional Physiotherapy program plus sleep hygiene technique

EXPERIMENTAL

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

control

OTHER

advices and home program

Other: Control arm

Interventions

Sleep Hygiene Techniques OTHER

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

Group receive conventional Physiotherapy program plus sleep hygiene technique

conventional physiotherapy program OTHER

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)

Group receive conventional Physiotherapy program

Control arm OTHER

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

control

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Uncontrolled systemic illnesses such as diabetes, cardiovascular disease, or cancer.
• Pregnancy.
• Participation in any recent physiotherapy program targeting neck pain within the last 3 months.

Sponsors & Collaborators

• Al-Azhar University: lead

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Neck Pain; Parasomnias; Mental Fatigue; Sleep Hygiene

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Fatigue; Behavioral Symptoms; Behavior; Health Behavior

Central Study Contacts

Mosab Aldabbas Aldabbas, PhD

CONTACT

00972597451222; mosab.m.aldabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Al Zhar University, Gaza, Palestine Field physiotherapy Officer, International committee of the red cross, Gaza

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 17, 2025
• Study Start: October 15, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 2, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09