ClinicalTrials.gg
Not yet recruitingNCT07761793DMR-CNPUpdated Aug 12, 2026

Diaphragmatic Myofascial Release Added to Neck Exercises for Chronic Neck Pain

An interventional study of Neck Exercise Program and Diaphragmatic Myofascial Release and Diaphragm-Directed Manual Therapy in Chronic Neck Pain, sponsored by Abdelrahman Alghoul. Not yet recruiting at 1 site in Palestinian Territories. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Abdelrahman Alghoul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Neck Pain

Keywords

  • Chronic Neck Pain
  • Diaphragmatic Myofascial Release
  • Neck Exercise
  • Manual Therapy
  • Physical Therapy
  • Kinesiophobia
  • Fatigue
  • Neck Disability
  • Pain Intensity
  • Diaphragmatic Breathing
03

In context

Kinesiophobia

285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.

This study's planned enrollment of 60 is above the median of 52 across 174 interventional studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

This is the only study on the registry with Abdelrahman Alghoul as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous cervical spine surgery.
  • Cervical radiculopathy or myelopathy.
  • History of fracture, inflammatory disease, , or neurological disorder.
  • Respiratory diseases such as (COPD) or severe asthma.
  • Current vestibular disorder.
  • Pregnancy.
  • Receipt of physical therapy or manual therapy during the previous 3 months.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: Neck Exercise Program

  • Experimental
    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.

    Other: Neck Exercise Program · Other: Diaphragmatic Myofascial Release and Diaphragm-Directed Manual Therapy

Interventions

  • OtherNeck Exercise Program

    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.

  • OtherDiaphragmatic Myofascial Release and Diaphragm-Directed Manual Therapy

    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.

06

What researchers measure

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.

07

Study locations

1 site
  • Alnos Street
    Gaza, Palestinian Territories
08

References and documents

Publications

  • 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. PubMed 25603749 ↗
  • Tatsios 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. PubMed 42279128 ↗
  • Tatsios 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. PubMed 36359533 ↗
  • Simoni 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. PubMed 33992285 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

Of 132 non-industry interventional studies with no phase under Kinesiophobia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 3 months is below that.

Counting every sponsor, half of 132 studies reached it within 8 months; a quarter within 4 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2026
First posted
Aug 12, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07761793
Lead sponsor
Abdelrahman Alghoul
Responsible party
Abdelrahman Alghoul (Master's Researcher in Physical Therapy, Al-Azhar University - Gaza) — Sponsor-investigator
First posted
Aug 12, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Abdelrahman Alghoul, BSc
Contact
a.s.alghoul98@gmail.com
+970595248697

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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