Effects of Manual Therapy and Exercise Training of Diaphragm in Patients With Chronic Neck Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Diaphragmatic Stretch Technique and Breathing Exercise Intervention in Patients With Chronic Neck Pain

Conditions
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Chronic Neck Pain

Intervention / Treatment
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* Other: Diaphragmatic Stretch Technique
* Other: Breathing Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy Group<br> | Other: Diaphragmatic Stretch Technique<br>* Diaphragmatic stretch technique is an intervention intended to indirectly stretch the diaphragmatic muscle fibers. This will help to decease tension generated by trigger points, normalizing muscle ﬁber length, and improve muscle contraction.<br>|
| Sham Comparator: Manual Control Group<br> | Other: Diaphragmatic Stretch Technique<br>* Diaphragmatic stretch technique is an intervention intended to indirectly stretch the diaphragmatic muscle fibers. This will help to decease tension generated by trigger points, normalizing muscle ﬁber length, and improve muscle contraction.<br>|
| Experimental: Breathing Training Group<br> | Other: Breathing Exercise Training<br>* During diaphragmatic or abdominal breathing training, inhalation will caused diaphragm contract downwards, inflating the lungs. This filling of the lungs pushes the abdominal organs down leading to expansion of the abdomen. Subjects are required to do few repetitions during the intervention.<br>|
| Sham Comparator: General Exercise Control Group<br> | Other: Breathing Exercise Training<br>* During diaphragmatic or abdominal breathing training, inhalation will caused diaphragm contract downwards, inflating the lungs. This filling of the lungs pushes the abdominal organs down leading to expansion of the abdomen. Subjects are required to do few repetitions during the intervention.<br>|
| Experimental: Manual Therapy Combined Breathing Training Group<br> | Other: Diaphragmatic Stretch Technique<br>* Diaphragmatic stretch technique is an intervention intended to indirectly stretch the diaphragmatic muscle fibers. This will help to decease tension generated by trigger points, normalizing muscle ﬁber length, and improve muscle contraction.<br>Other: Breathing Exercise Training<br>* During diaphragmatic or abdominal breathing training, inhalation will caused diaphragm contract downwards, inflating the lungs. This filling of the lungs pushes the abdominal organs down leading to expansion of the abdomen. Subjects are required to do few repetitions during the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 10 (Worst Outcome) | Change from baseline pain intensity up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Disability | Neck disability index - Questionnaire | Change from baseline functional disability up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Diaphragm, Breathing exercise, Breathing dysfunction