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

NCT04057963 | Unknown DMC

• 1 other identifier: 3758-GOA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain

Keywords

Inspiratory Muscle Training; Exercise; Cervical Posture

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Craniovertebral Angle

  change from baseline in disability at 6 weeks

• Pain threshold

  change from baseline in disability at 6 weeks

• Cervical Proprioception

  change from baseline in disability at 6 weeks

• Cranio-cervical flexion endurance

  change from baseline in disability at 6 weeks

• Diaphragma thickness

  change from baseline in disability at 6 weeks

Study Arms (2)

Conventional plus Functional Inspiratory Muscle Training Group

EXPERIMENTAL

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

Conventional Physiotherapy Program

ACTIVE COMPARATOR

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

Interventions

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 plus Functional Inspiratory Muscle Training Group

Conventional Physiotherapy Program OTHER

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

Conventional Physiotherapy Program

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• NDI score above 15
• Be able to adapt exercise commands
• Neck pain for at least six months
• Agree to participate in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (2)

Dokuz Eylul University, Department of Neurosurgery

Izmir, Inciraltı, 35340, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, 35340, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Central Study Contacts

Gamze YALCINKAYA, MSc

CONTACT

+902322775030; gamzeyalcinkaya11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 15, 2019
• Study Start: August 10, 2019
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

TU (2)