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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Treatment Group | Experimental | Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + experimental manoeuvres, 1 treatment/week. Each session will last about 30 minutes. |
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| Sham Treatment Group | Sham Comparator | Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + sham manoeuvres, 1 treatment/week. Each session will last about 30 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real Treatment Group | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Da Roit, PT, MSc | Università degli Studi di Ferrara, Physiotherapy Degree Course | Principal Investigator |
| Giulia Simoni, PT, OMT, MSc | Università degli Studi di Ferrara, Physiotherapy Degree Course | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisiotech - Studio Associato di Fisioterapia | Ferrara | 44121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33992285 | Derived | Simoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16. |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham Treatment Group | Behavioral | 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 |
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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 |