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

Not Applicable

• Conditions: Neck Pain
• Interventions: Other: Conventional plus Functional Inspiratory Muscle Training Group; Other: Conventional Physiotherapy Program

• Registration Number: NCT04057963
• Lead Sponsor: Dokuz Eylul University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-10
• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional plus Functional Inspiratory Muscle Training Group	Conventional plus Functional Inspiratory Muscle Training Group	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.
Conventional Physiotherapy Program	Conventional Physiotherapy Program	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.

Primary Outcome Measures

Name	Time	Method
Changes in Fear of Movement	change from baseline in disability at 6 weeks	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.
Changes in Pain Severity	change from baseline in pain severity at 6 weeks	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.
Changes in Depression	change from baseline in disability at 6 weeks	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
Changes in Disability	change from baseline in disability at 6 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation; 🇹🇷 Izmir, Turkey

Dokuz Eylul University, Department of Neurosurgery; 🇹🇷 Izmir, Inciraltı, Turkey