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

NCT ID: NCT07178496

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group receive 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.

Neck Endurance and Strength Training (30-40 minutes)

Group Type: EXPERIMENTAL

conventional physiotherapy program

Intervention Type: 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 plus sleep hygiene technique

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

Group Type: EXPERIMENTAL

Sleep Hygiene Techniques

Intervention Type: 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

control

advices and home program

Group Type: OTHER

Control arm

Intervention Type: 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

Interventions

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 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

Intervention Type: 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 Endurance and Strength Training (30-40 minutes)

Intervention Type: 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 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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mosab ALdabbas

Assistant Professor, Al Zhar University, Gaza, Palestine _ Field physiotherapy Officer, International committee of the red cross, Gaza

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mosab Aldabbas Aldabbas, PhD

Role: CONTACT

mosab.m.aldabbas@gmail.com

00972597451222

References

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.

Reference Type: RESULT

PMID: 36731933 (View on PubMed)

Other Identifiers

AL Azhar university, GAZA STRI

Identifier Type: -

Identifier Source: org_study_id