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.

Study Overview

• Status: Unknown
• Conditions: Neck Pain
• Intervention / Treatment: Other: Conventional plus Functional Inspiratory Muscle Training Group; Other: Conventional Physiotherapy Program

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35340
    • Recruiting
    • Dokuz Eylul University, School of Physical Therapy and Rehabilitation
    • Contact: Gamze YALCINKAYA, MSc; Email: gamzeyalcinkaya11@gmail.com
    • Principal Investigator: Gamze Yalcinkaya, MSc
    • Principal Investigator: Yesim Sengul Salik, Assoc. Prof.
    • Sub-Investigator: Seher Ozyurek, Assoc. Prof.
  • Inciraltı
    • Izmir, Inciraltı, Turkey, 35340
      • Recruiting
      • Dokuz Eylul University, Department of Neurosurgery
      • Contact: Orhan Kalemci, Assoc. Prof.; Phone Number: +902324123301; Email: orhankalemci@deu.edu.tr
      • Sub-Investigator: Orhan Kalemci, Assoc. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Conventional plus Functional Inspiratory Muscle Training Group; functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.
Active Comparator: 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.	Other: Conventional Physiotherapy Program; conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2019
• Primary Completion (Anticipated): August 10, 2021
• Study Completion (Anticipated): August 10, 2021

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Inspiratory Muscle Training; Cervical Posture
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Respiratory Aspiration; Neck Pain
• Other Study ID Numbers: 3758-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No