Clinical trial NCT04664842: Effects of Manual Therapy and Exercise Training of Diaphragm in Patients With Chronic Neck Pain
Official title: Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Ultrasonography
Diaphragm
Breathing exercise
Breathing dysfunction
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic neck pain is a commonly reported problem and often associated with functional disability. Studies showed that patients with chronic neck pain compensated with changes in breathing pattern. Primary functions of the diaphragm includes as the main respiratory muscle and contributing to the postural stability and spinal control. Diaphragm is located between the thorax and abdomen and has extensive and complex fascial connections to surrounding organs, muscles, and skeletons. Few studies showed that applying diaphragmatic manual techniques and breathing exercise training help to improve functions in patients with low back pain. However, how does the interventions directly influence on patients with chronic neck pain is still unclear. In this study, we make a hypothesis that diaphragmatic stretch technique and breathing exercise training help to reduce pain and improve functions in patients with chronic neck pain.

Detailed description: Chronic neck pain is a serious health problem with low quality of life, disability and economical burdens. Studies have found that nearly 83% of chronic neck pain patients had changes in breathing patterns. Compensated breathing pattern by using the neck-accessory respiratory muscles may result in excessive muscle strains and over-activations, which may also contribute to develop chronic neck pain. The diaphragm is the most important respiratory muscle which attached to the ribs and spine, and thus has an influence on spinal stability. Few studies have showed that diaphragm releasing and breathing training can reduce pain and improve flexibility of posterior chain muscles, spinal range of motions, and ribcage excursions in asymptomatic adults and patients with low back pain. However, the effects in patients with chronic neck pain has not bee determined. Therefore, there are two main purpose of this study. First, to determine the relationships among diaphragm mobility, neck pain and dysfunction, and respiratory in patients with chronic neck pain. Second, to investigate the effects of diaphragm releasing, breathing training, or combined intervention on pain and disability in patients with chronic neck pain. It is expected to recruit 150 patients with chronic neck pain and 30 healthy volunteers. Patients with chronic neck pain will be randomly assigned to (1) manual therapy group (2) manual control group (3) breathing training group (4) general exercise control group (5) manual therapy combined breathing training group. Each participant will receive a specific intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention including ultrasonography, cervical and thoracic function, respiratory functions, and autonomic balance.

Eligibility criteria: Inclusion Criteria:

* Chronic or recurrent neck pain from upper cervical to T1 area
* Condition last for 3 months and above

Exclusion Criteria:

* Acute neck pain
* Previous neck, shoulder or thoracic surgery
* Neurological disease
* Cardiopulmonary disease（Eg. Chronic obstructive pulmonary disease (COPD), pulmonary tuberculosis (TB), asthma, chronic bronchitis, pulmonary emphysema）
* Smoking
* Pregnancy
* Tumour
* Psychological disease
* Neuromuscular disease
* Back pain
* Anaemia or Diabetes
* Neck rehabilitation for past 12 month
* Scoliosis or other diseases that cause spine and chest deformity
* BMI \> 30

Primary outcomes:
measure: Pain Intensity
timeFrame: Change from baseline pain intensity up to 2 weeks
Secondary outcomes:
measure: Functional Disability
timeFrame: Change from baseline functional disability up to 2 weeks
Other outcomes:
measure: Neck and Thoracic ROM
timeFrame: Change from baseline neck and thoracic ROM up to 2 weeks
measure: Neck Muscle Endurance
timeFrame: Change from baseline neck muscle endurance up to 2 weeks
measure: Neck Muscle Strength
timeFrame: Change from baseline neck muscle strength up to 2 weeks
measure: Chest Mobility
timeFrame: Change from baseline check mobility up to 2 weeks
measure: Diaphragmatic Changes
timeFrame: Change from baseline diaphragmatic chages up to 2 weeks
measure: Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
timeFrame: Change from baseline MIP and MEP up to 2 weeks
measure: Lung Function
timeFrame: Change from baseline lung function up to 2 weeks
measure: Heart Rate Variability
timeFrame: Change from baseline heart rate variability up to 2 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
state: East District
Study officials:
References: