Skip to main content
Clinical Trials/NCT06377995
NCT06377995UnknownNot Applicable

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

Escola Superior de Tecnologia da Saúde do Porto1 site in 1 country45 target enrollmentStarted: September 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
45
Locations
1
Primary Endpoint
Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan

Study Overview

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©).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Double

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Placebo technique (Other)

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

Intervention: Diaphragm protocol (Other)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Natália Maria Oliveira Campelo

Teacher

Escola Superior de Tecnologia da Saúde do Porto

Study Sites (1)

Loading locations...

Similar Trials