Effectiveness of an Intervention Plan Aimed at the Diaphragm in Chronic Non-specific Neck Pain

NCT06377995 | Not Yet Recruiting

• 1 other identifier: OST1_013
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to analyse the effectiveness of an intervention plan targeting the diaphragm, namely stretching technique, neuromuscular diaphragm and phrenic centre inhibition, in the treatment of chronic non-specific neck pain.

Conditions

Chronic Neck Pain

Keywords

Neck pain; Diaphragm; Cervical spine; Young adult; Osteopathy

Outcome Measures

Primary Outcomes (2)

• Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan

  The questionnaire of Numerical Pain Scale (NPS) will be the instrument used to access the volunteer's pain, which consists of a numerical scale from 0 to 10, in which 0 is absence of pain and 10 is maximal pain. This questionnaire is carried out at rest and at the end of the available range of lateral inclinations and rotations of the cervical spine, which are the most painful movements in this pathology.

  12 minutes after the intervention

• Changes in range of motion after applying the diaphragm targeted protocol

  The range of motion of the cervical spine, rotations and lateral inclinations will be measured using the Goniometer Pro© (G-pro©) to compare the pre- and post-intervention samples. NPS questionnaire data will be collected from the subject's report and recorded in an Excel spreadsheet with the appropriate identification code. The range of motion data will be collected by the assessor and recorded in an Excel spreadsheet with the appropriate identification code.

  12 minutes after the intervention

Secondary Outcomes (2)

• Changes in pain level one week after the intervention

  One week after the intervention.

• Changes in range of motion one week later

  One week after the intervention.

Study Arms (2)

Placebo Comparator: Control group

PLACEBO COMPARATOR

Participants in the control group first rate their pain from 0 to 10 using the Numerical Pain Scale, at rest and at the end of the available range of lateral flexion and rotation. The amplitude of these movements is then assessed using a Goniometer Pro© (G-pro©). This assessment takes 10 minutes. After the initial assessment, the researcher performs the placebo technique, which lasts 12 minutes. Finally, the initial assessment is carried out again.

Other: Placebo technique

Experimental: Diaphragm protocol

EXPERIMENTAL

Participants in the experimental group first rate their pain from 0 to 10 using the Numerical Pain Scale, at rest and at the end of the available range of lateral flexion and rotation. The amplitude of these movements is then assessed using a Goniometer Pro© (G-pro©). This assessment takes 10 minutes. After the initial assessment, the researcher performs the diaphragm stretching, neuromuscular and phrenic centre inhibition technique; this treatment protocol lasts 12 minutes. Finally, the initial assessment is carried out again

Other: Diaphragm protocol

Interventions

Placebo technique OTHER

The patient is in a supine position with a 90° knees flexion. The osteopath lies cephalad to the patient and places their hands on their shoulders.

Placebo Comparator: Control group

Diaphragm protocol OTHER

The patient is in a supine position with a 90° knees flexion.To stretch the diaphragm, the osteopath stands at the head of the bed and places his hands on the lower edge of the ribcage and accompanies the lifting of the ribs during inhalation and maintains it during deep exhalation for up to 2 sets of 10 deep breaths separated by 1 minute. For the neuromuscular technique, the osteopath is positioned contralateral to the side to be treated and slides with the thumb under the lower part of the thorax, applying a force in the opposite direction.To inhibit the phrenic centre, the osteopath places one hand on the sternum in a caudal direction and the other in the projection of the phrenic centre in a cephalic direction.The participant inhales deeply and the osteopath presses in both directions during the expiratory phase for 10 respiratory cycles.

Experimental: Diaphragm protocol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Present a negative Jackson test;
• Have a body mass index (BMI) of 20-29.9 kg/m2;
• Suffer from chronic non-specific neck pain for 3 months or more.

You may not qualify if:

• Have a history of cervical spine surgery, as well as any trauma or fracture of the cervical spine, clavicle, scapula and ribs;
• Have specific neck pain due to degenerative diseases (disc prolapse, scoliosis);
• Having a congenital cervical deformity, such as torticollis;
• Being pregnant;
• Having rheumatic, oncological or respiratory pathologies;
• Have liver or gallbladder pathologies;
• Receiving physiotherapy, osteopathy, acupuncture or massage treatment for neck pain 3 months before and during participation in the study;
• Taking analgesics, anti-inflammatories or muscle relaxants 5 days prior to the intervention.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior de Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (11)

• Ahmad, A., Kamel, K. M., & Mohammed, R. G. (2020). Effect of forward head posture on diaphragmatic excursion in subjects with chronic neck pain. a case-control study. Physiotherapy Quarterly, 28(3), 9-13. https://doi.org/10.5114/pq.2020.95769

  BACKGROUND

• Chaitow, L., & Delany, J. (2008). Clinical application of neuromuscular techniques. Volume 1, The upper body. Churchill Livingstone Elsevier.

  BACKGROUND

• Haghighat F, Moradi R, Rezaie M, Yarahmadi N, Ghaffarnejad F. Added value of diaphragm myofascial release on forward head posture and chest expansion in women with symptomatic forward head posture: A randomized controlled trial. J Bodyw Mov Ther. 2025 Dec;45:645-651. doi: 10.1016/j.jbmt.2025.07.015. Epub 2025 Aug 8.

  PMID: 41316631 BACKGROUND

• Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290.

  PMID: 26340656 BACKGROUND

• Mármol, M. (2023). Efectos de la maniobra de inhibición fascial del diafragma sobre la columna cervical en pacientes con cervicalgia inespecífica. Revista de Investigación Osteopática, 3 (1), 22-28.

  BACKGROUND

• Silva ACO, Biasotto-Gonzalez DA, Oliveira FHM, Andrade AO, Gomes CAFP, Lanza FC, Amorim CF, Politti F. Effect of Osteopathic Visceral Manipulation on Pain, Cervical Range of Motion, and Upper Trapezius Muscle Activity in Patients with Chronic Nonspecific Neck Pain and Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Nov 11;2018:4929271. doi: 10.1155/2018/4929271. eCollection 2018.

  PMID: 30534176 BACKGROUND

• 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: 33992285 BACKGROUND

• Tatsios PI, Grammatopoulou E, Dimitriadis Z, Papandreou M, Paraskevopoulos E, Spanos S, Karakasidou P, Koumantakis GA. The Effectiveness of Spinal, Diaphragmatic, and Specific Stabilization Exercise Manual Therapy and Respiratory-Related Interventions in Patients with Chronic Nonspecific Neck Pain: Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Jun 30;12(7):1598. doi: 10.3390/diagnostics12071598.

  PMID: 35885502 BACKGROUND

• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.

  PMID: 29321111 BACKGROUND

• Rosas S, Paco M, Lemos C, Pinho T. Comparison between the Visual Analog Scale and the Numerical Rating Scale in the perception of esthetics and pain. Int Orthod. 2017 Dec;15(4):543-560. doi: 10.1016/j.ortho.2017.09.027. Epub 2017 Nov 13.

  PMID: 29146313 BACKGROUND

• Pourahmadi MR, Bagheri R, Taghipour M, Takamjani IE, Sarrafzadeh J, Mohseni-Bandpei MA. A new iPhone application for measuring active craniocervical range of motion in patients with non-specific neck pain: a reliability and validity study. Spine J. 2018 Mar;18(3):447-457. doi: 10.1016/j.spinee.2017.08.229. Epub 2017 Sep 7.

  PMID: 28890223 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Natália MO Campelo, PhD

  Escola Superior da Saúde do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

+35122 206 1000; nmc@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 22, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

PT (1)