Skip to main content
OpenTrials
Completed

NCT Number: NCT04057963

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neck Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University, Department of Neurosurgery, Izmir, Inciraltı, Turkey (Türkiye)

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conventional plus Functional Inspiratory Muscle Training Group

Other

functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.

Conventional Physiotherapy Program

Other

conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.

Primary outcomes

  1. Changes in Pain Severity

    Time frame: 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.

  2. Changes in Disability

    Time frame: 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.

  3. Changes in Fear of Movement

    Time frame: 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.

  4. Changes in Depression

    Time frame: 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

Secondary outcomes

  1. Craniovertebral Angle

    Time frame: change from baseline in disability at 6 weeks

    Photogrammetric method will be used to evaluate craniovertebral angle.

  2. Pain threshold

    Time frame: change from baseline in disability at 6 weeks

    Pain threshold will be measured by Algometer device.

  3. Cervical Proprioception

    Time frame: change from baseline in disability at 6 weeks

    Cervical Proprioception will be evaluated by laser pointer method.

  4. Cranio-cervical flexion endurance

    Time frame: change from baseline in disability at 6 weeks

    Cranio-cervical flexion endurance (activation score) will be measured by stabilizer pressure biofeedback unit.

  5. Diaphragma thickness

    Time frame: change from baseline in disability at 6 weeks

    Diaphragma thickness will be measured by two dimensional ultasonography

  6. Respiratory Muscle Strength

    Time frame: change from baseline in disability at 6 weeks

    Respiratory Muscle Strength (maximum inspiratory and expiratory mouth pressure) will be measured by Micro RPM device

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2019
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.