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Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Real Treatment Group

Sham Treatment Group

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Cervical spine;, Diaphragm;, Manual Therapy, Pain, Range of Motion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Fisiotech - Studio Associato di Fisioterapia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real Treatment Group

Sham Treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

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.

Adverse events

Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.

Full Information

NCT ID

NCT03223285

First Posted

July 4, 2017

Last Updated

May 27, 2019

Sponsor

Università degli Studi di Ferrara

1. Study Identification

Unique Protocol Identification Number

NCT03223285

Brief Title

Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 16, 2017 (Actual)

Primary Completion Date

May 16, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi di Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real Treatment Group

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Treatment Group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Real Treatment Group

Intervention Description

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

Intervention Name(s)

Sham Treatment Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Numeric Pain Rating Scale (NPRS)

Description

Time Frame

Week 0, 1, 2, 3, 13, 25

Secondary Outcome Measure Information:

Title

Change in Range of motion (ROM)

Description

Time Frame

Week 0, 1, 2, 3, 13, 25

Title

Change in Pain pressure threshold

Description

Time Frame

Week 0, 1, 2, 3, 13, 25

Title

Change in Neck Disability Index (NDI)

Description

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.

Time Frame

Week 0, 3, 13, 25

Title

Change in Medical outcomes study short form 36 (SF-36)

Description

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.

Time Frame

Week 0, 3, 13, 25

Title

Adverse events

Description

Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.

Time Frame

Week 2, 3, 13, 25

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Da Roit, PT, MSc

Organizational Affiliation

Università degli Studi di Ferrara, Physiotherapy Degree Course

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Giulia Simoni, PT, OMT, MSc

Organizational Affiliation

Università degli Studi di Ferrara, Physiotherapy Degree Course

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fisiotech - Studio Associato di Fisioterapia

City

Ferrara

ZIP/Postal Code

44121

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33992285

Citation

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.

Results Reference

derived

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Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

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