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NCT Number: NCT07761793

Diaphragmatic Myofascial Release Added to Neck Exercises for Chronic Neck Pain

Chronic neck pain can affect daily activities and may be associated with pain, disability, fear of movement, and fatigue. Exercise is commonly used to manage chronic neck pain, but some people continue to experience symptoms despite exercise treatment.

This study will investigate whether adding diaphragmatic myofascial release, a hands-on manual therapy directed toward the diaphragm and surrounding tissues, to a neck exercise program provides greater benefits than neck exercises alone in adults with chronic neck pain.

Sixty adults aged 25 to 60 years with chronic neck pain lasting more than three months will be randomly assigned to one of two groups. The control group will receive a supervised neck exercise program, while the intervention group will receive the same neck exercise program combined with diaphragmatic myofascial release and related diaphragmatic manual therapy. Both groups will receive treatment for six weeks, with three supervised sessions per week.

Pain, neck-related disability, fear of movement, and fatigue will be assessed before treatment, immediately after the six-week intervention, and four weeks after completion of treatment. The study will examine whether adding diaphragmatic myofascial release to neck exercises leads to greater improvements in these outcomes compared with neck exercises alone.

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Key information

Conditions

Chronic Neck Pain Anxiety Disorders Fatigue Kinesiophobia Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study is a prospective, assessor-blinded, parallel-group randomized controlled trial that will be conducted at the outpatient Physical Therapy Clinic of Nasser Medical Complex in the Gaza Strip. The study aims to evaluate the added effect of diaphragmatic myofascial release and diaphragm-directed manual therapy when combined with a standardized neck exercise program in adults with chronic neck pain.

Participants will be randomly allocated in a 1:1 ratio to either an intervention group or a control group using a computer-generated random sequence. The control group will receive a supervised neck exercise program that includes deep cervical flexor training, cervical stabilization, stretching, postural correction, scapular strengthening, and a home exercise program. The intervention group will receive the same neck exercise program in addition to a diaphragm-focused intervention that includes manual diaphragm release, diaphragmatic myofascial release, release of accessory respiratory muscles, and breathing re-education.

The intervention period will last six weeks, with three supervised treatment sessions per week. Outcomes will be assessed at baseline, immediately after the intervention, and at a four-week follow-up. The clinical outcomes include neck-related disability measured using the Neck Disability Index (NDI), pain intensity measured using the Numeric Pain Rating Scale (NPRS), kinesiophobia measured using the Tampa Scale of Kinesiophobia (TSK-17), and fatigue measured using the Fatigue Severity Scale (FSS).

The study will compare changes over time between the intervention and control groups to determine whether adding the diaphragmatic intervention to neck exercises provides additional benefits for patients with chronic neck pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 25-60 years.
  • Diagnosis of chronic neck pain lasting longer than 3 months.
  • Ability to understand and follow instructions.

Exclusion criteria

  • Previous cervical spine surgery.
  • Cervical radiculopathy or myelopathy.
  • History of fracture, inflammatory disease, malignancy, or neurological disorder.
  • Respiratory diseases such as chronic obstructive pulmonary disease (COPD) or severe asthma.
  • Current vestibular disorder.
  • Pregnancy.
  • Receipt of physical therapy or manual therapy during the previous 3 months.

Treatment and study plan

Neck Exercise Program

Other

A supervised neck exercise program including deep cervical flexor training, cervical stabilization exercises, stretching of the upper trapezius, levator scapulae, pectoralis major, and sternocleidomastoid muscles, postural correction exercises, scapular strengthening, and a daily home exercise program. Participants will attend 3 supervised sessions per week for 6 weeks.

Diaphragmatic Myofascial Release and Diaphragm-Directed Manual Therapy

Other

The diaphragm-focused intervention includes manual diaphragm release using gentle sustained traction under the lower costal margin during exhalation; diaphragmatic myofascial release targeting the lower ribs, xiphoid region, costal margins, and related fascial structures; manual release of accessory respiratory muscles including the sternocleidomastoid, scalenes, upper trapezius, and pectoralis minor; and diaphragmatic breathing re-education.

Primary outcomes

  1. Change in Neck Disability Index (NDI) Score

    Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention

    Neck-related disability will be assessed using the Neck Disability Index (NDI), a 10-item self-reported questionnaire assessing the impact of neck pain on daily functioning. Each item is scored from 0 to 5, producing a total score from 0 to 50, which can be expressed as a percentage from 0% to 100%. Higher scores indicate greater neck-related disability.

  2. Change in Neck Disability Index (NDI) Score

    Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.

    Neck-related disability will be assessed using the Neck Disability Index (NDI), a 10-item self-reported questionnaire assessing the impact of neck pain on daily functioning. Each item is scored from 0 to 5, producing a total score from 0 to 50, which can be expressed as a percentage from 0% to 100%. Higher scores indicate greater neck-related disability.

Secondary outcomes

  1. Change in Tampa Scale of Kinesiophobia (TSK-17) Score

    Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.

    Kinesiophobia will be assessed using the 17-item Tampa Scale of Kinesiophobia (TSK-17). Each item is rated on a 4-point Likert scale, with total scores ranging from 17 to 68. Higher scores indicate greater fear of movement or reinjury.

  2. Change in Numeric Pain Rating Scale (NPRS) Score

    Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). Participants will rate their average neck pain over the previous week on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  3. Change in Fatigue Severity Scale (FSS) Score

    Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.

    Fatigue will be assessed using the 9-item Fatigue Severity Scale (FSS). Each item is rated from 1 to 7. The mean of the nine items will be calculated, resulting in a score from 1 to 7, with higher scores indicating greater fatigue severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Alghoul, BSc

CONTACT

[email protected]

+970595248697

Sponsors and collaborators

Lead sponsor

Abdelrahman Alghoul

Other

Registry information

Official study title

Effect of Adding Diaphragmatic Myofascial Release to a Neck Exercise Program on Pain, Disability, Fatigue, and Kinesiophobia Among Patients With Chronic Neck Pain in the Gaza Strip: A Randomized Controlled Trial

Acronym: DMR-CNP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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