Diaphragmatic Myofascial Release Added to Neck Exercises for Chronic Neck Pain
DMR-CNP
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
Study Completion
Last participant's last visit for all outcomes
January 1, 2027
August 12, 2026
August 1, 2026
3 months
August 8, 2026
August 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention
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.
Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention.
Secondary Outcomes (3)
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.
Study Arms (2)
Neck Exercise Program
ACTIVE COMPARATORParticipants 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.
Neck Exercise Program + Diaphragmatic Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Men and women aged 25-60 years.
- Diagnosis of chronic neck pain lasting longer than 3 months.
- Ability to understand and follow instructions.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alnos Street
Gaza, Palestinian Territories
Related Publications (4)
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
PMID: 25603749BACKGROUNDTatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Cervical Spine and Diaphragm Manual Therapy Combined with Breathing Re-Education Exercises on Musculoskeletal, Respiratory and Psychophysiological Outcomes in Patients with Non-Specific Chronic Neck Pain: A Randomized Controlled Trial. J Clin Med. 2026 May 31;15(11):4266. doi: 10.3390/jcm15114266.
PMID: 42279128BACKGROUNDTatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Manual Therapy in the Cervical Spine and Diaphragm, in Combination with Breathing Reeducation Exercises, in Patients with Non-Specific Chronic Neck Pain: Protocol for Development of Outcome Measures and a Randomized Controlled Trial. Diagnostics (Basel). 2022 Nov 4;12(11):2690. doi: 10.3390/diagnostics12112690.
PMID: 36359533BACKGROUNDSimoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16.
PMID: 33992285BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Master's Researcher in Physical Therapy
Study Record Dates
First Submitted
August 8, 2026
First Posted
August 12, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
August 12, 2026
Record last verified: 2026-08