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Chronic Neck PainNCT06377995

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

A study testing Diaphragm protocol in people with Chronic Neck Pain, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Chronic Neck Pain
What is being tested?
Diaphragm protocol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 sitePortugal
Study dates
Sep 2024to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Natália MO Campelo, PhD contact

+35122 206 1000

nmc@ess.ipp.pt

Portugal1 site
  • Escola Superior de Saúde do Porto

    Porto, 4200-072

    Natália MO Campelo, PhD, +35122 206 1000, nmc.ess.ipp@gmail.com

    Natália MO Campelo, PhD

Other trials in Portugal

About this study

Official title: Effectiveness of an Intervention Plan Targeting the Diaphragm in Young Adults With Chronic Non-specific Neck Pain: Randomised Clinical Trial

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.

Read the detailed description

Chronic neck pain is defined as pain and discomfort between the superior nuchal line and the spinous process of the first thoracic vertebra, which may radiate to the scapula, anterior chest wall, skull or upper limbs. It is classified as chronic if the pain persists for more than 12 weeks. Associated symptoms include headache, dizziness and pain or paresthesia in the upper limbs. These symptoms interfere with daily life and have a negative impact on physical and mental health.

The aetiology of this pathology is multifactorial and the triggering factors may vary due to the close relationship that the cervical spine has with other structures, namely the diaphragm muscle.

Our aim is to verify the effectiveness of an osteopathic treatment protocol targeting the diaphragm in chronic non-specific neck pain in young adults. Specifically, to analyse whether the mechanical, fascial and neural pathways established by the defined manual techniques, namely stretching techniques, neuromuscular inhibition of the diaphragm and the phrenic centre, have any effect on active movements (rotations and inclinations) and chronic neck pain.

This study will analyse the effects of diaphragmatic techniques on the following variables: Numerical Pain Scale and Goniometer Pro© (G-pro©).

Being tested
Placebo technique, Diaphragm protocol
Keywords
Neck pain, Diaphragm, Cervical spine, Young adult, Osteopathy
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo techniqueOther

    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.

  • Diaphragm protocolOther

    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.

Study groups in NCT06377995
Study groupRoleWhat they receive
Placebo Comparator: Control groupPlacebo comparatorParticipants 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.
Receives: Other: Placebo technique
Experimental: Diaphragm protocolExperimentalParticipants 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
Receives: Other: Diaphragm protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 minutes after the intervention

  2. 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.

    Measured: 12 minutes after the intervention

Secondary outcomes (2)
  1. Changes in pain level one week after the intervention

    One week later, the volunteers will take the Numerical Pain Scale (NPS) questionnaire again to access the volunteers pain, which consists of a numerical scale from 0 to 10, where 0 is no pain and 10 is maximum 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.

    Measured: One week after the intervention.

  2. Changes in range of motion one week later

    The range of motion of the rotation and lateral tilt of the cervical spine is measured again using a Goniometer Pro© (G-pro©).

    Data from the NPS questionnaire will be collected from the patient report and recorded in an Excel document with the corresponding identification code.

    The range of motion data is collected by the assessor and recorded in an Excel spreadsheet with the appropriate identification code.

    Measured: One week after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study startSep 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377995
Sponsor's protocol ID
OST1_013
Status last verified
Apr 2024
First submitted
5 Apr 2024
Last updated
22 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

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

  • 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.

    PubMed 41316631
  • 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.

    PubMed 26340656
  • 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.

  • 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.

    PubMed 30534176
  • 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
  • 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.

    PubMed 35885502
  • 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.

    PubMed 29321111
  • 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.

    PubMed 29146313
  • 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.

    PubMed 28890223

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragm protocol in people with Chronic Neck Pain, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Natália MO Campelo, PhD (+35122 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan (time frame: 12 minutes after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06377995, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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