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

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional plus Functional Inspiratory Muscle Training Group
Conventional Physiotherapy Program
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Inspiratory Muscle Training, Exercise, Cervical Posture

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Dokuz Eylul University, Department of NeurosurgeryRecruiting
  • Dokuz Eylul University, School of Physical Therapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional plus Functional Inspiratory Muscle Training Group

Conventional Physiotherapy Program

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2019
Last Updated
September 9, 2019
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04057963
Brief Title
The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain
Official Title
The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2019 (Actual)
Primary Completion Date
August 10, 2021 (Anticipated)
Study Completion Date
August 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Inspiratory Muscle Training, Exercise, Cervical Posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional plus Functional Inspiratory Muscle Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Physiotherapy Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional plus Functional Inspiratory Muscle Training Group
Intervention Description
functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy Program
Intervention Description
conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.
Primary Outcome Measure Information:
Title
Changes in Pain Severity
Description
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.
Time Frame
change from baseline in pain severity at 6 weeks
Title
Changes in Disability
Description
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.
Time Frame
change from baseline in disability at 6 weeks
Title
Changes in Fear of Movement
Description
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.
Time Frame
change from baseline in disability at 6 weeks
Title
Changes in Depression
Description
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
Time Frame
change from baseline in disability at 6 weeks
Secondary Outcome Measure Information:
Title
Craniovertebral Angle
Description
Photogrammetric method will be used to evaluate craniovertebral angle.
Time Frame
change from baseline in disability at 6 weeks
Title
Pain threshold
Description
Pain threshold will be measured by Algometer device.
Time Frame
change from baseline in disability at 6 weeks
Title
Cervical Proprioception
Description
Cervical Proprioception will be evaluated by laser pointer method.
Time Frame
change from baseline in disability at 6 weeks
Title
Cranio-cervical flexion endurance
Description
Cranio-cervical flexion endurance (activation score) will be measured by stabilizer pressure biofeedback unit.
Time Frame
change from baseline in disability at 6 weeks
Title
Diaphragma thickness
Description
Diaphragma thickness will be measured by two dimensional ultasonography
Time Frame
change from baseline in disability at 6 weeks
Title
Respiratory Muscle Strength
Description
Respiratory Muscle Strength (maximum inspiratory and expiratory mouth pressure) will be measured by Micro RPM device
Time Frame
change from baseline in disability at 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze YALCINKAYA, MSc
Phone
+902322775030
Email
gamzeyalcinkaya11@gmail.com
Facility Information:
Facility Name
Dokuz Eylul University, Department of Neurosurgery
City
Izmir
State/Province
Inciraltı
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orhan Kalemci, Assoc. Prof.
Phone
+902324123301
Email
orhankalemci@deu.edu.tr
First Name & Middle Initial & Last Name & Degree
Orhan Kalemci, Assoc. Prof.
Facility Name
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze YALCINKAYA, MSc
Email
gamzeyalcinkaya11@gmail.com
First Name & Middle Initial & Last Name & Degree
Gamze Yalcinkaya, MSc
First Name & Middle Initial & Last Name & Degree
Yesim Sengul Salik, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Seher Ozyurek, Assoc. Prof.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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