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Chronic Neck PainNCT05229393

Manual Therapy to the Cervical Spine and Diaphragm Combined With Breathing Reeducation Exercises, in nsCNP Patients

A study testing Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises and Conventional Physiotherapy Program in people with Chronic Neck Pain, run by University of West Attica at 1 site in Greece.

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

Chronic neck pain (CNP) is reported to be one of the most common musculoskeletal pain syndromes. Studies showed that patients with chronic neck pain compensated with changes in Pain, Function, Musculoskeletal and Respiratory outcomes. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Chronic Neck Pain
What is being tested?
Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises and Conventional Physiotherapy Program
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteGreece
Study dates
31 Oct 2022to 21 Nov 2023
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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who have pain for at least 3 months with non-specific mechanical neck pain
  • Individuals voluntarily participating in the study
  • Patients will also be selected on the basis of demonstrating DB in at least one of a series of tests conducted to assess the extent of their Dysfunctional Breathing (biomechanical, biochemical, psychological)

Who cannot join

  • Pregnancy
  • Contraindications for manual therapy or inability to complete the treatment
  • Patients who received physiotherapy or osteopathic treatment during the last 3 months
  • Individuals with bronchial asthma, chronic bronchitis, emphysema, bronchiectasis and malignancy
  • Medical diagnosis of rheumatologic disease
  • Medical diagnosis of respiratory disease (COPD, asthma)
Show all 18Show fewer
  • Spine surgery (cervical, spinal, thoracic or abdominal region)
  • Medical diagnosis of cancer (past or present)
  • Whiplash injuries
  • Previous cervical fracture
  • Cervical anatomical changes
  • Thrombotic events, Anaemia or Diabetes
  • Body temperature greater than 37 degrees in the previous 48 hours
  • Obesity (BMI greater than 40)
  • Scoliosis or other diseases that cause spine and chest deformity
  • Positive cervical region instability and positive vertebral artery test
  • Individuals with neurological deficits or with motor loss
  • Individuals who have whiplash injuries, osteoporosis, or rheumatoid disease (such as rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome)

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Tatsios Petros

    Glyfada, Athens, 16561

Other trials in Greece

About this study

Official title: The Effectiveness of Manual Therapy to the Cervical Spine and Diaphragm,Combined With Breathing Reeducation Exercises, in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial

Chronic neck pain (CNP) is reported to be one of the most common musculoskeletal pain syndromes. Studies showed that patients with chronic neck pain compensated with changes in Pain, Function, Musculoskeletal and Respiratory outcomes. The diaphragm is a primary respiratory muscle contributing to postural stability and spinal control. Many studies showed that manual therapy and exercise improve clinical and respiratory outcomes in CNP patients. Few studies highlight the importance of diaphragm manual therapy and Reeducation Breathing Exercises in musculoskeletal diseases and in CNP patients. However, the exact mechanism is still unclear. This study aims to examine the hypothesis that: "Diaphragm Manual Therapy and Breathing Reeducation Exercises combined with cervical manual therapy - improve clinical and respiratory outcomes more than cervical manual therapy intervention only or conventional physiotherapy

Read the detailed description

Chronic neck pain (CNP) may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain is a major cause of morbidity and disability in everyday life and at the workplace, in many different countries and populations, but its basic pathology and pathophysiology are still unclear.

CNP patients present respiratory dysfunction and pain presence is accompanied by a varying amount of decrements in several clinical outcomes affecting the neuromusculoskeletal system like disability, range of motion restriction, and decreased proprioception as well as neuromuscular control. However, the quality of life and psychology of patients with CNP are affected in parallel. The diaphragm is the most important respiratory muscle also contributing to postural stability and spinal control. Several studies have shown that diaphragm manual therapy and breathing retraining exercises can improve respiratory, as well as pain, function, and musculoskeletal outcomes in chronic low back pain. However, the effectiveness in patients with chronic neck pain has not been definitively determined in relation to other physical therapy interventions. The primary purpose of the present study is to determine further the effectiveness of Diaphragmatic Manual Therapy and Breathing Reeducation Exercises in CNP patients. The secondary purpose is to investigate the relationship between CNP, breathing dysfunction, pain, disability, and musculoskeletal clinical outcomes.

The present study is expected to recruit 90 patients with CNP. Patients with CNP will be randomly assigned to (1) Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises (2) Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy and (3) Conventional Physiotherapy. Each participant will receive a particular intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention.

Being tested
Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises, Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy, Conventional Physiotherapy Program
Keywords
neck pain,diaphragm manual, manual therapy

What participants receive

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

  • Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation ExercisesOther

    Diaphragmatic Manual Therapy consists of techniques intended to indirectly stretch and mobilize the diaphragmatic muscle fibers. This will help to improve muscle contraction and decrease tension. The experimental maneuvers include the Doming Diaphragmatic Technique as described by Leon Chaitow, Lewit, and the Manual Diaphragmatic Release Technique as described by Leon Chaitow. Both maneuvers are performed in two sets of 10 repetitions, within a 1-minute interval.

    Cervical Manual Therapy consists of vertebral mobilization techniques according to the Mulligan technique.

    Breathing Reeducation Exercises consist of i) recognition of the abnormal breathing pattern, ii) relaxation techniques for all the primary and accessory respiratory muscles, iii) diaphragm breathing reeducation iv) pursed lips exercise v) reeducation of the normal breathing rate

  • Cervical Manual Therapy plus sham Diaphragmatic Manual TherapyOther

    Ultrasound sham as Diaphragmatic Manual techniques. Disconnected ultrasound will be applied in the same position as for the experimental group for 15 min as a placebo treatment.

    Cervical Manual Therapy: will consist of vertebral mobilization techniques according to Mulligan -

  • Conventional Physiotherapy ProgramOther

    Conventional Physiotherapy Program consists of TENS for 15min, Microwave pulsed Diathermy for 10min, soft tissue techniques for 15min

Study groups in NCT05229393
Study groupRoleWhat they receive
Diaphragmatic Manual Therapy Group AExperimentalExperimental: Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises group. Cervical manual therapy will be the same as for the Manual Control Group (20 minutes). Diaphragmatic Manual Therapy (10 minutes) and Breathing Reeducation Exercises (10 minutes). The program will be carried out three times per week lasting four weeks in total. Each session will last about 40 minutes.
Receives: Other: Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises
Cervical Manual Therapy Group BSham comparatorSham Comparator: Sham Treatment group or Manual Control Group Patients included in this group will receive Cervical Manual Therapy (25 minutes) plus sham Diaphragmatic Manual techniques (15 minutes). The program will be carried out three times per week lasting four weeks in total. Each session will last about 40 minutes.
Receives: Other: Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy
Conventional Physiotherapy Program Group CActive comparatorActive Comparator: Conventional Treatment group Patients included in this group will receive a conventional physiotherapy program with Transcutaneous Electrical Nerve Stimulation-TENS (15 minutes) plus Microwave pulsed Diathermy (10 minutes), and soft tissue techniques (15 minutes). The program will be carried out three sessions per week during the four weeks. Each session will last about 40 minutes.
Receives: Other: Conventional Physiotherapy Program

What is being measured

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

  1. Change in Neck Disability Index (NDI)

    The NDI consists of 10 sections. Each section is scored on a 0 (no pain) to 5 (worst imaginable pain) rating scale. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.

    Measured: change from baseline up to 4 weeks and up to 3 months

  2. Pain Intensity VAS

    Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)

    Measured: change from baseline up to 4 weeks and up to 3 months

Secondary outcomes (11)

  1. Change in Range of motion (ROM)

    A smartphone-based application and KFORCE SENS electronic goniometer, KINVENT, France will be used to accurately measure ROM during neck movements of Flexion-Extension, Left-Right Side Flexion, and Left-Right Rotation.

    Measured: change from baseline up to 4 weeks and up to 3 months

  2. Craniovertebral Angle

    Lateral Photography- examination of the FHP through lateral photographs can provide very reliable estimates. The reliability remained high in both the sitting and standing position.

    Measured: change from baseline up to 4 weeks and up to 3 months

  3. Nijmegen Questionnaire (NQ)

    Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining.

    Measured: change from baseline up to 4 weeks and up to 3 months

  4. Hi-Lo test

    A test that assesses breathing dysfunction. Instructions will be given to the examiners for how to perform and record the Hi-Lo: ''Examiner at the front and slightly to the side of the person have to place one hand on the sternum of the patient and the other hand on their upper abdomen. The examiner has to determine whether thoracic or abdominal motion is dominant during breathing and to what extent this is so. Also, has to check for paradoxical breathing. The extent of thoracic or abdominal breathing rate using a score between 1 and 3.

    Measured: change from baseline up to 4 weeks and up to 3 months

  5. Single Breath Count (SBC)

    A test that assesses breathing dysfunction. To perform, ask the patient to count out loud after maximal inspiration. The ability to reach 50 indicates normal respiratory function.

    Measured: change from baseline up to 4 weeks and up to 3 months

  6. End Tidal CO2 (ETCO2) and Respiratory Rate (RR)

    Measured by Capnography. ETCO2 less than 35 mmHg, RR of 16 breaths/min or more, will be considered as signs of respiratory pattern abnormality.

    Measured: change from baseline up to 4 weeks and up to 3 months

  7. Breath Holding Time

    A test that assesses DB. This test is an indicator of a person's respiratory response to biochemical, biomechanical, and psychological fac-tors, and it seems that abnormally, shortened, BHT may indicate abnormalities in the respiratory function that are closely related to DB. Participants will be instructed to assume a comfortable sitting position and breath usually and gently in and out and at the end of a normal exhalation, they will be asked to pinch their nose and hold their breath. The instruction is to hold their breath until they cannot hold their breath any longer and require breathing in again. According to Kiesel (2020) [30], a BHT <25 secs is con-sidered as a sign of DB.

    Measured: change from baseline up to 4 weeks and up to 3 months

  8. Chest Expansion

    The difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome

    Measured: change from baseline up to 4 weeks and up to 3 months

  9. Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)

    Assesses the level of anxiety and depression experienced by patients in a hospital outpatient clinic. A subscale score >8 denotes anxiety or depression.

    Measured: change from baseline up to 4 weeks and up to 3 months

  10. Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)

    Kinesiophobia is one of the most frequently employed measures for assessing pain-related fear in pain patients through a 17-item questionnaire.

    Measured: change from baseline up to 4 weeks and up to 3 months

  11. Adverse events

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

    Measured: change from baseline up to 4 weeks and up to 3 months

Timeline

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

  1. First posted8 Feb 2022
  2. Study start31 Oct 2022
  3. Primary completion21 Nov 2023
  4. Study completion21 Nov 2023

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
Model description
Parallel Assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229393
Sponsor's protocol ID
UWestAttica300921
Status last verified
Nov 2023
First submitted
27 Jan 2022
Last updated
24 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant data collected during the trial, after deidentification.

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

  • Hwangbo PN, Hwangbo G, Park J, Lee S. The Effect of Thoracic Joint Mobilization and Self-stretching Exercise on Pulmonary Functions of Patients with Chronic Neck Pain. J Phys Ther Sci. 2014 Nov;26(11):1783-6. doi: 10.1589/jpts.26.1783. Epub 2014 Nov 13.

    PubMed 25435700

  • Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.

    PubMed 28602744

  • Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.

    PubMed 33275908

  • Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.

    PubMed 30774207

  • Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.

    PubMed 33464539

  • Wirth B, Amstalden M, Perk M, Boutellier U, Humphreys BK. Respiratory dysfunction in patients with chronic neck pain - influence of thoracic spine and chest mobility. Man Ther. 2014 Oct;19(5):440-4. doi: 10.1016/j.math.2014.04.011. Epub 2014 Apr 30.

    PubMed 24835338

  • Kapreli E, Vourazanis E, Strimpakos N. Neck pain causes respiratory dysfunction. Med Hypotheses. 2008;70(5):1009-13. doi: 10.1016/j.mehy.2007.07.050. Epub 2007 Oct 23.

    PubMed 17959320

  • Dimitriadis Z, Podogyros G, Polyviou D, Tasopoulos I, Passa K. The Reliability of Lateral Photography for the Assessment of the Forward Head Posture Through Four Different Angle-Based Analysis Methods in Healthy Individuals. Musculoskeletal Care. 2015 Sep;13(3):179-186. doi: 10.1002/msc.1095. Epub 2015 Jan 30. No abstract available.

    PubMed 25640070

  • Tatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Cervical Spine and Diaphragm Manual Therapy Combined with Breathing Re-Education Exercises on Musculoskeletal, Respiratory and Psychophysiological Outcomes in Patients with Non-Specific Chronic Neck Pain: A Randomized Controlled Trial. J Clin Med. 2026 May 31;15(11):4266. doi: 10.3390/jcm15114266.

    PubMed 42279128

Questions about this trial

What is this clinical trial studying?

A study testing Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises and Conventional Physiotherapy Program in people with Chronic Neck Pain, run by University of West Attica at 1 site in Greece.

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 18 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 24 Nov 2023. 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 Greece. 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 Neck Disability Index (NDI) (time frame: change from baseline up to 4 weeks and up to 3 months). The study lists 2 primary outcomes in all. 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 NCT05229393, which also lists 10 linked publications.

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 24 Nov 2023.

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