Clinical trial NCT06377995: Effectiveness of an Intervention Plan Aimed at the Diaphragm in Chronic Non-specific Neck Pain
Official title: Effectiveness of an Intervention Plan Targeting the Diaphragm in Young Adults With Chronic Non-specific Neck Pain: Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Neck pain
Diaphragm
Cervical spine
Young adult
Osteopathy
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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©).

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.

Primary outcomes:
measure: Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan
timeFrame: 12 minutes after the intervention
measure: Changes in range of motion after applying the diaphragm targeted protocol
timeFrame: 12 minutes after the intervention
Secondary outcomes:
measure: Changes in pain level one week after the intervention
timeFrame: One week after the intervention.
measure: Changes in range of motion one week later
timeFrame: One week after the intervention.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior de Saúde do Porto
Study officials:
affiliation: Escola Superior da Saúde do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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