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IRCT20260609069722N1 IRCT 2026-06-20 Tehran University of Medical Sciences Effect of Diaphragm Manual Release Combined with Upper Trapezius Myofascial Release in Patients with Mechanical Neck Pain Evaluating the Impact of Diaphragm Manual Release Combined with Upper Trapezius Myofascial Release on Mechanical Neck Pain and Active Trigger Points: A Randomized Controlled Trial 2026-06-17 anticipated 28 Recruiting https://irct.ir/trial/90954 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Two-arm parallel randomized controlled trial comparing upper trapezius myofascial release alone versus upper trapezius myofascial release combined with diaphragm manual release in patients with chronic mechanical neck pain. Treatment will be provided three times per week for four weeks, Randomization description: Eligible participants will be randomly allocated into two groups in a 1:1 ratio. Randomization will be performed using a computer-generated random sequence with allocation concealment through sequentially numbered opaque sealed envelopes prepared by an independent researcher, Blinding description: Outcome assessments will be performed by an independent physiotherapist who is blinded to group allocation. The assessor will not participate in treatment sessions and will remain unaware of the intervention received by participants. N/A Chronic Mechanical Neck Pain. Intervention 1: Control group: Participants will receive upper trapezius myofascial release only, three sessions per week for four weeks. Each session will last approximately 15 minutes. Intervention 2: Intervention group: Participants will receive upper trapezius myofascial release combined with diaphragm manual release, three sessions per week for four weeks. Each session will last approximately 25 minutes. Yes - There is a plan to make this available What will be shared: De-identified participant dataset, study protocol, statistical analysis results, and informed consent template related to the trial evaluating diaphragm manual release combined with upper trapezius myofascial release in patients with chronic mechanical neck pain. When: Data and supporting documents will be available upon reasonable request beginning 6 months after publication of the study results and will remain available for 5 years. To whom: De-identified data and study documents will be available to qualified researchers, clinicians, and academic investigators conducting scientific research. Conditions: Data may be used for scientific research, secondary analyses, systematic reviews, and meta-analyses following approval of a reasonable research proposal. Where to obtain: Requests should be sent by email to the principal investigator, Mohammed Basim Mohammed Alkhafajy, at the corresponding study email address. How to obtain: Researchers must submit a written request describing the purpose of data use. Requests will be reviewed by the principal investigator, and approved applicants will receive access to de-identified data. Comments:
public Mohammed Basim Mohammed Alkhafajy
House 53, Alley 68, District 334, Al-Kurayat, Baghdad, Iraq
Baghdad Iraq 00000 +964 770 298 4898 mbmhkh1989@gmail.com Tehran University of Medical Sciences scientific Dr. Azadeh Shadmehr
International Campus, Tehran University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 00000 +98 912 370 3379 shadmehr@tums.ac.ir Tehran University of Medical Sciences Iraq Age 18–55 years. Mechanical neck pain for more than 3 months NPRS between 30–80 mm At least one active upper trapezius trigger point BMI 18.5–29.9. Ability to attend treatment sessions Ability to understand questionnaires. 18 years 55 years Both Cervical trauma or surgery Neurological disorders Respiratory disorders Radicular pain Pregnancy Recent neck pain intervention Inability to complete assessments M54.2 Cervicalgia Treatment - Other Treatment - Other Control group: Participants will receive upper trapezius myofascial release only, three sessions per week for four weeks. Each session will last approximately 15 minutes. Intervention group: Participants will receive upper trapezius myofascial release combined with diaphragm manual release, three sessions per week for four weeks. Each session will last approximately 25 minutes. Pain Intensity. Timepoint: Before intervention and immediately after completion of the 4-week treatment program. Method of measurement: Numeric Pain Rating Scale (NPRS), 0–10 scale. Neck Disability. Timepoint: Before intervention and immediately after completion of the 4-week treatment program. Method of measurement: Neck Disability Index (NDI). Pain Pressure Threshold (PPT). Timepoint: Before intervention and immediately after completion of the 4-week treatment program. Method of measurement: Measured using a digital pressure algometer over the upper trapezius trigger point (kg/cm²). Cervical Range of Motion (ROM). Timepoint: Before intervention and immediately after completion of the 4-week treatment program. Method of measurement: Measured using an inclinometer for cervical flexion, extension, lateral flexion, and rotation (degrees). Chest Expansion. Timepoint: Before intervention and immediately after completion of the 4-week treatment program. Method of measurement: Measured using a tape measure at the xiphoid level during maximum inspiration and expiration (cm). Patient Global Impression of Change (PGIC). Timepoint: Immediately after completion of the 4-week treatment program. Method of measurement: Measured using the 7-point Patient Global Impression of Change (PGIC) scale. Tehran University of Medical Sciences Approved 2026-01-05 Ethics Committee of Faculty of Nursing and Midwifery and Rehabilitation, Tehran University of Medica Tehran, Shahrak Qods (West), between South Flamack and Zarafshan, Simaye Iran Street - Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th Floor Tehran Tehran Iran (Islamic Republic of)