The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain

Study Overview
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Brief Summary
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The aim of the present study is to investigate the effects of additional functional inspiratory muscle training in individuals with non-specific chronic neck pain.

Detailed Description
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Patients participating in the study will be divided two parallel groups. The patients in study group will instruct to perform both functional inspiratory muscle training and conventional treatments for neck pain, the patients in the control group will instruct to perform just conventional treatments. The severity of the pain, disability, fear of movement and depression levels will be assessed by visual analog scale, neck disability index, Tampa Scale of kinesiophobia and beck depression inventory, respectively. Neck postures (craniovertebral angle) will be evaluated by photogrammetric method.Endurance of deep cervical flexor muscles will be measured using Stabilizer Pressure Biofeedback Unit with cranio-cervical flexion test. Pain threshold will be measured by algometer from the middle point of upper trapezius. Cervical proprioceptions will be evaluated by laser pointer method in the right and left rotational directions. In addition, diaphragma thickness will be measured by two-dimensional ultrasonography. Assessments were repeated before and after the treatment.

Official Title
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The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Conventional plus Functional Inspiratory Muscle Training Group
* Other: Conventional Physiotherapy Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NDI score above 15 Be able to adapt exercise commands Neck pain for at least six months Agree to participate in the study Exclusion Criteria: History of spinal surgery Traumatic cervical injuries Acute or chronic musculoskeletal pain other than neck pain Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric) Tumoral conditions Obesity (Body Mass Index-BMI> 40)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional plus Functional Inspiratory Muscle Training Group<br>Conventional program plus functional inspiratory muscle training will be carried out three sessions per week during the six weeks. The content of the program will be the same as for the conventional group. Additional functional inspiratory muscle training will be began with 50% of the maximal inspiratory pressure value in a specific device and it will be progressed 5% every week according to the tolerance. | Other: Conventional plus Functional Inspiratory Muscle Training Group<br>* functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.<br>|
| Active Comparator: Conventional Physiotherapy Program<br>Conventional program will be carried out three sessions per week during the six weeks. Cervical mobilization techniques (glidings-grade 2) of cyriax will be applied in the direction of lateral flexion and rotation. Stretching exercises, craniovertebral flexion exercise and scapulothoracic strengthening exercises will be performed. | Other: Conventional Physiotherapy Program<br>* conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Severity | Patients' resting pain intensities will be assessed by Visual Analog Scale. (a 10 cm horizontal line). There is two anchors in the tips of the visual analog scale and while the zero represented no pain, ten indicated excessive pain. The length from the zero to marked point was recorded in cm. | change from baseline in pain severity at 6 weeks | 
| Changes in Disability | Patients' disability levels will be assessed by neck disability index. The questionnaire has ten sections; pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored between zero (no disability) and five (total disability). The maximum score is therefore 50. Higher scores indicates having more disability. | change from baseline in disability at 6 weeks | 
| Changes in Fear of Movement | Patients' fear of movement will be assesed by Tampa Kinesiophobia Scale. The scale has 17 pain statements, and the patient selected her agreement for each question using a 4-point scale. The maximum score is 68. Higher score indicates having more fear of movement. | change from baseline in disability at 6 weeks | 
| Changes in Depression | Patients' depression levels will be assessed by Beck Depression Inventory. composed 21 questions. The maximum total score is 63. Higher scores demonstrate greater level of depression | change from baseline in disability at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craniovertebral Angle | Photogrammetric method will be used to evaluate craniovertebral angle. | change from baseline in disability at 6 weeks | 
| Pain threshold | Pain threshold will be measured by Algometer device. | change from baseline in disability at 6 weeks | 
| Cervical Proprioception | Cervical Proprioception will be evaluated by laser pointer method. | change from baseline in disability at 6 weeks | 
| Cranio-cervical flexion endurance | Cranio-cervical flexion endurance (activation score) will be measured by stabilizer pressure biofeedback unit. | change from baseline in disability at 6 weeks | 
| Diaphragma thickness | Diaphragma thickness will be measured by two dimensional ultasonography | change from baseline in disability at 6 weeks | 
| Respiratory Muscle Strength | Respiratory Muscle Strength (maximum inspiratory and expiratory mouth pressure) will be measured by Micro RPM device | change from baseline in disability at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory Muscle Training, Exercise, Cervical Posture