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

NCT ID: NCT06377995

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2024-12-31

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.

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©).

Conditions

Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Comparator: Control group

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.

Group Type: PLACEBO_COMPARATOR

Placebo technique

Intervention Type: 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.

Experimental: Diaphragm protocol

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

Group Type: EXPERIMENTAL

Diaphragm protocol

Intervention Type: 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.

Interventions

Placebo technique

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.

Intervention Type: OTHER

Diaphragm protocol

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role: lead

Responsible Party

Natália Maria Oliveira Campelo

Teacher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natália MO Campelo, PhD

Role: PRINCIPAL_INVESTIGATOR

Escola Superior da Saúde do Porto

Locations

Escola Superior de Saúde do Porto

Porto, , Portugal

Countries

Portugal

Central Contacts

Natália MO Campelo, PhD

Role: CONTACT

nmc@ess.ipp.pt

+35122 206 1000

Facility Contacts

Natália MO Campelo, PhD

Role: primary

nmc.ess.ipp@gmail.com

+35122 206 1000

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Haghighat, F., Moradi, R., Rezaie, M., Yarahmadi, N., Ghaffarnejad, F. (2020). Added Value of Diaphragm Myofascial Release on Forward Head Posture and Chest Expansion in Patients With Neck Pain: A Randomized Controlled Trial. Research Square. https://doi.org/10.21203/rs.3.rs-53279/v1

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

OST1_013

Identifier Type: -

Identifier Source: org_study_id