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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057963
• Other study ID #: 3758-GOA
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: August 10, 2021

Study information

• Verified date: September 2019
• Source: Dokuz Eylul University
• Contact: Gamze YALCINKAYA, MSc
• Phone: +902322775030
• Email: gamzeyalcinkaya11[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neck Pain
• Respiratory Aspiration

Intervention

Other:
• Conventional plus Functional Inspiratory Muscle Training Group
functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.
• Conventional Physiotherapy Program
conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University, Department of Neurosurgery	Izmir	Inciralti
Turkey	Dokuz Eylul University, School of Physical Therapy and Rehabilitation	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Dokuz Eylul University, Scientific Research Projects Coordination Unit

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Craniovertebral Angle	Photogrammetric method will be used to evaluate craniovertebral angle.	change from baseline in disability at 6 weeks
Secondary	Pain threshold	Pain threshold will be measured by Algometer device.	change from baseline in disability at 6 weeks
Secondary	Cervical Proprioception	Cervical Proprioception will be evaluated by laser pointer method.	change from baseline in disability at 6 weeks
Secondary	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
Secondary	Diaphragma thickness	Diaphragma thickness will be measured by two dimensional ultasonography	change from baseline in disability at 6 weeks
Secondary	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