Neck PainNCT04057963
The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain
A study testing Conventional plus Functional Inspiratory Muscle Training Group and Conventional Physiotherapy Program in people with Neck Pain, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- Conventional plus Functional Inspiratory Muscle Training Group and Conventional Physiotherapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Aug 2019to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- NDI score above 15
- Be able to adapt exercise commands
- Neck pain for at least six months
- Agree to participate in the study
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dokuz Eylul University, Department of Neurosurgery
Izmir, Inciraltı, 35340
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Izmir, 35340
About this study
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Conventional plus Functional Inspiratory Muscle Training Group, Conventional Physiotherapy Program
- Keywords
- Inspiratory Muscle Training, Exercise, Cervical Posture
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional plus Functional Inspiratory Muscle Training GroupOther
functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.
Conventional Physiotherapy ProgramOther
conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: change from baseline in disability at 6 weeks
Secondary outcomes (6)
Craniovertebral Angle
Photogrammetric method will be used to evaluate craniovertebral angle.
Measured: change from baseline in disability at 6 weeks
Pain threshold
Pain threshold will be measured by Algometer device.
Measured: change from baseline in disability at 6 weeks
Cervical Proprioception
Cervical Proprioception will be evaluated by laser pointer method.
Measured: 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.
Measured: change from baseline in disability at 6 weeks
Diaphragma thickness
Diaphragma thickness will be measured by two dimensional ultasonography
Measured: 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
Measured: change from baseline in disability at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start10 Aug 2019
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze YALCINKAYA, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057963
- Sponsor's protocol ID
- 3758-GOA
- Status last verified
- Sep 2019
- First submitted
- 11 Aug 2019
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04057963
- Acronym / sponsor ID
- 3758-GOA
- Conditions
- Neck Pain
- Keywords
- Inspiratory Muscle Training, Exercise, Cervical Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Conventional plus Functional Inspiratory Muscle Training Group | Experimental | Other: Conventional plus Functional Inspiratory Muscle Training GroupConventional 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 Physiotherapy Program | Active comparator | Other: Conventional Physiotherapy ProgramConventional 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- NDI score above 15
- Be able to adapt exercise commands
- Neck pain for at least six months
- Agree to participate in the study
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional plus Functional Inspiratory Muscle Training Groupfunctional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle. | Other | Conventional plus Functional Inspiratory Muscle Training Group |
| Conventional Physiotherapy Programconventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises. | Other | Conventional Physiotherapy Program |
Primary outcome
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.
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.
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.
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
6 secondary outcomes
Craniovertebral Angle
Time frame: change from baseline in disability at 6 weeks
Pain threshold
Time frame: change from baseline in disability at 6 weeks
Cervical Proprioception
Time frame: change from baseline in disability at 6 weeks
Cranio-cervical flexion endurance
Time frame: change from baseline in disability at 6 weeks
Diaphragma thickness
Time frame: change from baseline in disability at 6 weeks
Respiratory Muscle Strength
Time frame: change from baseline in disability at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional plus Functional Inspiratory Muscle Training Group and Conventional Physiotherapy Program in people with Neck Pain, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain Severity (time frame: change from baseline in pain severity at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.