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Completed

NCT Number: NCT03223285

Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisiotech - Studio Associato di Fisioterapia

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. Adverse events

    Time frame: Week 2, 3, 13, 25

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

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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