Diaphragmatic Myofascial Release Added to Neck Exercises for Chronic Neck Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorAbdelrahman Alghoul

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged 25-60 years.

Diagnosis of chronic neck pain lasting longer than 3 months.

Ability to understand and follow instructions.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neck Exercise Program

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Neck Exercise ProgramActive comparator 1 intervention
Group B: Neck Exercise Program + Diaphragmatic InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Neck Disability Index (NDI) Score

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.

Time frame
Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention
2

Change in Neck Disability Index (NDI) Score

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.

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

Secondary outcomes

1

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

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.

Time frame
Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.
2

Change in Numeric Pain Rating Scale (NPRS) Score

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.

Time frame
Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention
3

Change in Fatigue Severity Scale (FSS) Score

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abdelrahman Alghoul

Lead sponsor

Al-Azhar University - Gaza

Sponsor institution

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