Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of diaphragm's manual therapy in addition to cervical spine manual therapy in terms of pain, cervical spine range of motion, trigger points pain pressure threshold, disability and quality of life in patient with chronic aspecific neck pain.

Official Title
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Diaphragm's Manual Therapy Reduce Pain in Patients With Chronic Neck Pain: a Randomised Controlled Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Behavioral: Real Treatment Group
* Behavioral: Sham Treatment Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neck pain since at least 3 months Age > 18 years and < 65 years Male or Female Exclusion Criteria: Pregnancy Contraindications for manual therapy or inability to complete the treatment Patients who received a physiotherapy or osteopathic treatment during the last 3 months Medical diagnosis of rheumatologic disease Medical diagnosis of respiratory disease (COPD, asthma) Spine surgery Medical diagnosis of past or present cancer Thoracic or abdominal surgery in the last 3 years Whiplash injuries Previous cervical fracture Cervical anatomical changes Thrombotic events Body temperature greater than 37 degrees in the previous 48 hours Obesity (BMI greater than 30)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real Treatment Group<br>Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + experimental manoeuvres, 1 treatment/week. Each session will last about 30 minutes. | Behavioral: Real Treatment Group<br>* Real Diaphragm manoeuvres The experimental manoeuvres include the Doming The Diaphragm Technique as described by Digiovanna (2004), Chila (2011) and Yao (2014) and the Manual Diaphragm Release Technique as described by Ricard (2009), De Coster (2005) and Roha (2015). Both manoeuvres are performed in two sets of 10 repetitions, within a 1-minute interval. Multifaced physiotherapy/osteopathic treatment includes: vertebral mobilisations (C0-D1), high-velocity low-amplitude (HVLA) thrusts of the cervical spine, soft tissue techniques<br>|
| Sham Comparator: Sham Treatment Group<br>Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + sham manoeuvres, 1 treatment/week. Each session will last about 30 minutes. | Behavioral: Sham Treatment Group<br>* Sham Diaphragm manoeuvre: the physiotherapist will simply lie hands on the rib cage, and rest along the anterolateral costal margin below rib 7, during normal breathing of the patient for 40 breathes. Multifaced physiotherapy/osteopathic treatment includes: vertebral mobilisations (C0-D1), high-velocity low-amplitude (HVLA) thrusts of the cervical spine, soft tissue techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale (NPRS) | The NPRS is an 11-point scale from 0-10 (0 = no pain; 10 = the most intense pain imaginable). Measures the subjective intensity of pain. Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours. | Week 0, 1, 2, 3, 13, 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range of motion (ROM) | Using the Baseline Bubble Inclinometer (Mayer 1993, Cleland, 2006), placed on the vertex of the head, taken the ROM with the patient sitting straight (flexion, extension and lateral inclinations) and supine (rotations). | Week 0, 1, 2, 3, 13, 25 | 
| Change in Pain pressure threshold | Using a LIZARD Ahi-o-meter (CE), the change of the pain on the trigger points is measured, with the patient in sitting position, in upper trapezium and sternocleidomastoid muscle bilaterally, by the detection of trigger points from a map. | Week 0, 1, 2, 3, 13, 25 | 
| Change in Neck Disability Index (NDI) | The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. | Week 0, 3, 13, 25 | 
| Change in Medical outcomes study short form 36 (SF-36) | The SF-36 is a generic patient-reported outcome measure aimed at quantifying health status, and is often used as a measure of health-related quality of life. | Week 0, 3, 13, 25 | 
| Adverse events | Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment. | Week 2, 3, 13, 25 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical spine;, Diaphragm;, Manual Therapy, Pain, Range of Motion