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

November 22, 2022 updated by: Tatsios Petros, University of West Attica

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: University of West Attica

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
    • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaphragmatic Manual Therapy Group A

Experimental: 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.
Other: Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises

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
Sham Comparator: Cervical Manual Therapy Group B
Sham 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.
Other: Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy

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 -
Active Comparator: Conventional Physiotherapy Program Group C

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck Disability Index (NDI)
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
Pain Intensity VAS
Time Frame: change from baseline up to 4 weeks and up to 3 months
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)
change from baseline up to 4 weeks and up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Range of motion (ROM)
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
Craniovertebral Angle
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
Nijmegen Questionnaire (NQ)
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
Hi-Lo test
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
Single Breath Count (SBC)
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
End Tidal CO2 (ETCO2) and Respiratory Rate (RR)
Time Frame: change from baseline up to 4 weeks and up to 3 months
Measured by Capnography. ETCO2 less than 35 mmHg, RR of 16 breaths/min or more, will be considered as signs of respiratory pattern abnormality.
change from baseline up to 4 weeks and up to 3 months
Breath Holding Time
Time Frame: change from baseline up to 4 weeks and up to 3 months
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.
change from baseline up to 4 weeks and up to 3 months
Chest Expansion
Time Frame: change from baseline up to 4 weeks and up to 3 months
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
change from baseline up to 4 weeks and up to 3 months
Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)
Time Frame: change from baseline up to 4 weeks and up to 3 months
Assesses the level of anxiety and depression experienced by patients in a hospital outpatient clinic. A subscale score >8 denotes anxiety or depression.
change from baseline up to 4 weeks and up to 3 months
Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)
Time Frame: change from baseline up to 4 weeks and up to 3 months
Kinesiophobia is one of the most frequently employed measures for assessing pain-related fear in pain patients through a 17-item questionnaire.
change from baseline up to 4 weeks and up to 3 months
Adverse events
Time Frame: change from baseline up to 4 weeks and up to 3 months
Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.
change from baseline up to 4 weeks and up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of West Attica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 28, 2023

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWestAttica300921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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