Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

NCT03223285 | Completed

• 1 other identifier: Pilota_cervicalgia_diaframma
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Range of motion (ROM)

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

• Change in Pain pressure threshold

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

• Change in Neck Disability Index (NDI)

  Week 0, 3, 13, 25

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

  Week 0, 3, 13, 25

• Adverse events

  Week 2, 3, 13, 25

Study Arms (2)

Real Treatment Group

EXPERIMENTAL

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

Sham Treatment Group

SHAM COMPARATOR

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

Interventions

Real Treatment Group 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

Real Treatment Group

Sham Treatment Group 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

Sham Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neck pain since at least 3 months
• Age \> 18 years and \< 65 years
• Male or Female

You may not qualify if:

• 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)

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Fisiotech - Studio Associato di Fisioterapia

Ferrara, 44121, Italy

Location

Related Publications (1)

• 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.

  PMID: 33992285 DERIVED

MeSH Terms

Conditions

Neck Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 21, 2017
• Study Start: May 16, 2017
• Primary Completion: May 16, 2018
• Study Completion: December 31, 2018
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

IT (1)