Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

May 27, 2019 updated by: Marco Da Roit, Università degli Studi di Ferrara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • Fisiotech - Studio Associato di Fisioterapia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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
SHAM_COMPARATOR: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: Week 0, 1, 2, 3, 13, 25

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)
Time Frame: Week 0, 1, 2, 3, 13, 25
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
Time Frame: Week 0, 1, 2, 3, 13, 25
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)
Time Frame: Week 0, 3, 13, 25
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)
Time Frame: Week 0, 3, 13, 25
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
Time Frame: Week 2, 3, 13, 25
Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.
Week 2, 3, 13, 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2017

Primary Completion (ACTUAL)

May 16, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pilota_cervicalgia_diaframma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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