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Clinical Trials/NCT05229393
NCT05229393
Completed
Not Applicable

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

University of West Attica1 site in 1 country90 target enrollmentOctober 31, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Neck Pain
Sponsor
University of West Attica
Enrollment
90
Locations
1
Primary Endpoint
Pain Intensity VAS
Status
Completed
Last Updated
2 years ago

Overview

Brief 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. 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

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2022
End Date
November 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tatsios Petros

Phd cand., MSc, MSc, OMPT, CMP, Clinical Instructor Manual Therapy

University of West Attica

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 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.

Secondary Outcomes

  • Nijmegen Questionnaire (NQ)(change from baseline up to 4 weeks and up to 3 months)
  • Hi-Lo test(change from baseline up to 4 weeks and up to 3 months)
  • Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)(change from baseline up to 4 weeks and up to 3 months)
  • Change in Range of motion (ROM)(change from baseline up to 4 weeks and up to 3 months)
  • Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)(change from baseline up to 4 weeks and up to 3 months)
  • Craniovertebral Angle(change from baseline up to 4 weeks and up to 3 months)
  • End Tidal CO2 (ETCO2) and Respiratory Rate (RR)(change from baseline up to 4 weeks and up to 3 months)
  • Breath Holding Time(change from baseline up to 4 weeks and up to 3 months)
  • Adverse events(change from baseline up to 4 weeks and up to 3 months)
  • Single Breath Count (SBC)(change from baseline up to 4 weeks and up to 3 months)
  • Chest Expansion(change from baseline up to 4 weeks and up to 3 months)

Study Sites (1)

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