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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Neck Disability Index (NDI) Score
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Neck Exercise Program
Participants will receive a supervised neck exercise program consisting of deep cervical flexor training, cervical stabilization exercises, stretching exercises, postural correction, scapular strengthening, and a home exercise program. The intervention will be provided for 6 weeks with 3 supervised sessions per week.
Intervention: Neck Exercise Program (Other)
Neck Exercise Program + Diaphragmatic Intervention
Participants will receive the same supervised neck exercise program as the active comparator group, combined with a diaphragm-focused intervention consisting of manual diaphragm release, diaphragmatic myofascial release, release of accessory respiratory muscles, and breathing re-education. Treatment will be provided for 6 weeks with 3 supervised sessions per week.
Intervention: Neck Exercise Program (Other)
Neck Exercise Program + Diaphragmatic Intervention
Participants will receive the same supervised neck exercise program as the active comparator group, combined with a diaphragm-focused intervention consisting of manual diaphragm release, diaphragmatic myofascial release, release of accessory respiratory muscles, and breathing re-education. Treatment will be provided for 6 weeks with 3 supervised sessions per week.
Intervention: Diaphragmatic Myofascial Release and Diaphragm-Directed Manual Therapy (Other)
Outcomes
Primary Outcomes
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.
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
- Change in Tampa Scale of Kinesiophobia (TSK-17) Score(Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.)
- Change in Numeric Pain Rating Scale (NPRS) Score(Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention)
- Change in Fatigue Severity Scale (FSS) Score(Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.)
Investigators
Abdelrahman Alghoul
Master's Researcher in Physical Therapy
Al-Azhar University - Gaza