Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Behavioral: Real Treatment Group; Behavioral: Sham Treatment Group

• Registration Number: NCT03223285
• Lead Sponsor: Università degli Studi di Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-16
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Primary Completion: 2018-05-16
• Study Completion: 2018-12-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real Treatment Group	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.
Sham Treatment Group	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.

Primary Outcome Measures

Name	Time	Method
Change in Numeric Pain Rating Scale (NPRS)	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	Week 2, 3, 13, 25	Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.
Change in Range of motion (ROM)	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).
Change in Pain pressure threshold	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.
Change in Neck Disability Index (NDI)	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.
Change in Medical outcomes study short form 36 (SF-36)	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.

Trial Locations

Locations (1)

Fisiotech - Studio Associato di Fisioterapia; 🇮🇹 Ferrara, Italy