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

April 19, 2024 updated by: Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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©).

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natália MO Campelo, PhD
  • Phone Number: +35122 206 1000
  • Email: nmc@ess.ipp.pt

Study Locations

  • Portugal
      • Porto, Portugal, 4200-072
        • Escola Superior de Saúde do Porto
        • Principal Investigator:
          • Natália MO Campelo, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: 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.
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan
Time Frame: 12 minutes after the intervention
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
Time Frame: 12 minutes after the intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain level one week after the intervention
Time Frame: 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.
One week after the intervention.
Changes in range of motion one week later
Time Frame: One week after the intervention.

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.
One week after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, PhD, Escola Superior da Saúde do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OST1_013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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