NCT07761793

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 8, 2026

Last Update Submit

August 8, 2026

Conditions

Keywords

Chronic Neck PainDiaphragmatic Myofascial ReleaseNeck ExerciseManual TherapyPhysical TherapyKinesiophobiaFatigueNeck DisabilityPain IntensityDiaphragmatic Breathing

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 COMPARATOR

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

Neck Exercise Program + Diaphragmatic Intervention

EXPERIMENTAL

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 ProgramOther: Diaphragmatic Myofascial Release and Diaphragm-Directed Manual Therapy

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.

Neck Exercise ProgramNeck Exercise Program + Diaphragmatic 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.

Neck Exercise Program + Diaphragmatic Intervention

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 25603749BACKGROUND
  • 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.

    PMID: 42279128BACKGROUND
  • 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.

    PMID: 36359533BACKGROUND
  • 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.

    PMID: 33992285BACKGROUND

MeSH Terms

Conditions

KinesiophobiaFatiguePain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Central Study Contacts

Abdelrahman Alghoul, BSc

CONTACT

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

Locations