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Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03223285
Enrollment
40
Registered
2017-07-21
Start date
2017-05-16
Completion date
2018-12-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

Cervical spine;, Diaphragm;, Manual Therapy, Pain, Range of Motion

Brief summary

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.

Interventions

BEHAVIORALReal Treatment Group

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

BEHAVIORALSham Treatment Group

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

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Numeric Pain Rating Scale (NPRS)Week 0, 1, 2, 3, 13, 25The 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.

Secondary

MeasureTime frameDescription
Change in Range of motion (ROM)Week 0, 1, 2, 3, 13, 25Using 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).
Change in Pain pressure thresholdWeek 0, 1, 2, 3, 13, 25Using 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.
Change in Neck Disability Index (NDI)Week 0, 3, 13, 25The 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.
Change in Medical outcomes study short form 36 (SF-36)Week 0, 3, 13, 25The 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.
Adverse eventsWeek 2, 3, 13, 25Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026