Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

NCT ID: NCT03223285

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2018-12-31

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.

Detailed Description

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Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real Treatment Group

Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + experimental manoeuvres, 1 treatment/week. Each session will last about 30 minutes.

Group Type EXPERIMENTAL

Real Treatment Group

Intervention Type 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

Sham Treatment Group

Patients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + sham manoeuvres, 1 treatment/week. Each session will last about 30 minutes.

Group Type SHAM_COMPARATOR

Sham Treatment Group

Intervention Type 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

Interventions

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Real 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

Intervention Type BEHAVIORAL

Sham 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

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Marco Da Roit

PT, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Da Roit, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara, Physiotherapy Degree Course

Giulia Simoni, PT, OMT, MSc

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara, Physiotherapy Degree Course

Locations

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Fisiotech - Studio Associato di Fisioterapia

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 33992285 (View on PubMed)

Other Identifiers

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Pilota_cervicalgia_diaframma

Identifier Type: -

Identifier Source: org_study_id

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