Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223285
• Other study ID #: Pilota_cervicalgia_diaframma
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neck Pain

Intervention

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 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

Locations

Country	Name	City	State
Italy	Fisiotech - Studio Associato di Fisioterapia	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Week 0, 1, 2, 3, 13, 25
Secondary	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
Secondary	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
Secondary	Adverse events	Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.	Week 2, 3, 13, 25