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Neck PainNCT03223285

Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

A study testing Real Treatment Group in people with Neck Pain, run by Università degli Studi di Ferrara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neck Pain
What is being tested?
Real Treatment Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteItaly
Study dates
16 May 2017to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fisiotech - Studio Associato di Fisioterapia

    Ferrara, 44121

Other trials in Italy

About this study

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

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
Being tested
Real Treatment Group, Sham Treatment Group
Keywords
Cervical spine;, Diaphragm;, Manual Therapy, Pain, Range of Motion
Medical subject headings
Neck Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real Treatment GroupBehavioural

    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 GroupBehavioural

    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

Study groups in NCT03223285
Study groupRoleWhat they receive
Real Treatment GroupExperimentalPatients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + experimental manoeuvres, 1 treatment/week. Each session will last about 30 minutes.
Receives: Behavioral: Real Treatment Group
Sham Treatment GroupSham comparatorPatients included in this group will receive 3 multifaced physiotherapy/osteopathic treatments + sham manoeuvres, 1 treatment/week. Each session will last about 30 minutes.
Receives: Behavioral: Sham Treatment Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. 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).

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

  2. 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.

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

  3. 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.

    Measured: Week 0, 3, 13, 25

  4. 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.

    Measured: Week 0, 3, 13, 25

  5. Adverse events

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

    Measured: Week 2, 3, 13, 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start16 May 2017
  3. Primary completion16 May 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223285
Sponsor's protocol ID
Pilota_cervicalgia_diaframma
Status last verified
May 2019
First submitted
4 Jul 2017
Last updated
29 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33992285

Questions about this trial

What is this clinical trial studying?

A study testing Real Treatment Group in people with Neck Pain, run by Università degli Studi di Ferrara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numeric Pain Rating Scale (NPRS) (time frame: Week 0, 1, 2, 3, 13, 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.

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