Clinical trial NCT05229393: Manual Therapy to the Cervical Spine and Diaphragm Combined With Breathing Reeducation Exercises, in nsCNP Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: neck pain,diaphragm manual, manual therapy
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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
  * 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)

Primary outcomes:
measure: Change in Neck Disability Index (NDI)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Pain Intensity VAS
timeFrame: change from baseline up to 4 weeks and up to 3 months
Secondary outcomes:
measure: Change in Range of motion (ROM)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Craniovertebral Angle
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Nijmegen Questionnaire (NQ)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Hi-Lo test
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Single Breath Count (SBC)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: End Tidal CO2 (ETCO2) and Respiratory Rate (RR)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Breath Holding Time
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Chest Expansion
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)
timeFrame: change from baseline up to 4 weeks and up to 3 months
measure: Adverse events
timeFrame: change from baseline up to 4 weeks and up to 3 months
Other outcomes:
Locations:
city: Glyfada
country: Greece
facility: Tatsios Petros
state: Athens
Study officials:
References:
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