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

NCT ID: NCT04057963

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2021-08-10

Brief Summary

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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

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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.

Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single (Participant)

Study Groups

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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.

Group Type EXPERIMENTAL

Conventional plus Functional Inspiratory Muscle Training Group

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy Program

Intervention Type OTHER

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

Interventions

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Conventional plus Functional Inspiratory Muscle Training Group

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

Intervention Type OTHER

Conventional Physiotherapy Program

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gamze YALCINKAYA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylul University, Department of Neurosurgery

Izmir, Inciraltı, Turkey (Türkiye)

Site Status RECRUITING

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gamze YALCINKAYA, MSc

Role: CONTACT

+902322775030

Facility Contacts

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Orhan Kalemci, Assoc. Prof.

Role: primary

+902324123301

Gamze YALCINKAYA, MSc

Role: primary

Other Identifiers

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3758-GOA

Identifier Type: -

Identifier Source: org_study_id

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