Chronic Neck PainNCT07272551
The Effectiveness of the Polyvagal Theory in Chronic Neck Pain
A study testing Intervention 1 and Intervention 2 in people with Chronic Neck Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effectiveness of a polyvagal theory-based exercise approach on joint position sense, pain, range of motion, functionality, depression, and quality of life in individuals with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Intervention 1 and Intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals diagnosed with chronic neck pain of Grade 1 or 2, lasting at least 3 months
- Individuals whose pain is clinically evaluated and diagnosed
- Individuals with a pain score of 3 or higher on the Visual Analog Scale
Who cannot join
- Individuals diagnosed with chronic neck pain of Grade 3 or 4
- History of trauma or surgical intervention in the neck region
- Cervical disc herniation, cervical stenosis, or other serious neurological conditions
- Upper extremity radiculopathy
- Acute inflammation or infection
- Severe pathological conditions (e.g., inflammatory diseases, neoplasms, fractures)
Show all 9Show fewer
- Individuals unable to participate in exercises due to mental or physical impairments
- Pregnancy
- Individuals who have received physiotherapy for chronic neck pain within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effectiveness of the Polyvagal Theory-based Exercise Approach in Chronic Neck Pain
This study aimed to examine the effectiveness of a polyvagal theory-based exercise approach on joint position sense, pain, range of motion, functionality, depression, and quality of life in individuals with chronic neck pain.
H0 = The polyvagal theory-based exercise approach has no significant effect on joint position sense, neck pain, range of motion, functionality, depression, or quality of life.
H1 = The polyvagal theory-based exercise approach has a significant effect on joint position sense, neck pain, range of motion, functionality, depression, and quality of life.
Read the detailed description
Neck pain is one of the most common musculoskeletal problems that negatively impacts individuals' health and quality of life. When chronic painful conditions occur in musculoskeletal disorders, mood disorders such as depression and anxiety can also occur. A long-term history of neck pain is associated with stress, poor quality of life, and decreased functionality.
Polyvagal theory advocates working with the body, becoming aware of it, and connecting with the senses. Exercises based on polyvagal theory can be specifically designed and customized to stimulate the vagus nerve, promote relaxation, and enhance social interaction by following the principles of polyvagal theory.
While polyvagal theory is often used in psychology, it has only been used in rehabilitation in one study, with the potential to improve quality of life by inhibiting the sympathetic nervous system and activating the parasympathetic nervous system, thereby reducing pain perception and stress.
This study, in which participants were divided into three groups: control, intervention 1, and intervention 2, aimed to examine the effectiveness of a polyvagal theory-based exercise approach on joint position sense, pain, range of motion, functionality, depression, and quality of life in individuals with chronic neck pain.
- Conditions
- Chronic Neck Pain
- Being tested
- Control, Intervention 1, Intervention 2
- Keywords
- Neck Pain, chronic neck pain, Vagal Nerve Stimulation, Joint Position Sense, Rehabilitation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Participants in this study will undergo traditional, painless cervical exercises twice a week for 8 weeks. Each exercise will be performed for 10 repetitions and 3 sets. The exercises are as follows:
Traditional, painless cervical exercises will consist of 10 slow repetitions of each of the following cervical movements, starting from a natural resting head position: left rotation, right rotation, flexion, extension, left lateral flexion, and right lateral flexion. Isometric neck exercises will be performed in a straight line forward, backward, right, and left direction, with the patient's own hands providing resistance in the opposite direction.
Shoulder active ROM exercises will involve participants performing shoulder flexion, abduction up to 90°, and external and internal rotation exercises with their elbows flexed to 90° and their arms at their sides. Additionally, they will be asked to perform shoulder rolls forward and backward while standing.
Intervention 1Other
In this study, participants will undergo polyvagal theory-based exercises twice a week for 8 weeks, totaling 16 sessions. The exercises are categorized into four main groups: sensory awareness exercises, progressive muscle relaxation, vocalization exercises, and self-soothing touch exercises. Sensory awareness exercises include focused breathing, awareness of upright postures and bodily sensations, lying on the back with eyes closed while focusing on positive thoughts, and walking mindfully in a calm environment. Progressive muscle relaxation involves sequentially tensing and relaxing muscle groups from the toes to the head and visualizing calming scenes through guided imagery. Vocalization exercises consist of tongue trills producing a "ben" sound, humming with a closed mouth, and sustaining vowel sounds. Self-soothing touch exercises include massaging the feet, mindfully touching the arms, face, and palms, and practicing abdominal breathing.
Intervention 2Other
Participants in this study will receive exercises based on polyvagal theory in addition to traditional, painless cervical exercises twice a week for 8 weeks. Each exercise will be performed for 3 sets of 10 repetitions. Participants will rest for two seconds after each repetition and five seconds after each set. The exercise content will be the same as described above.
One set of polyvagal theory-based exercises will be performed. The exercise content will be the same as described above. The intervention will not be progressive, and the same intervention content will be used for 16 sessions. The intervention will be administered by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in this group will undergo traditional, painless cervical exercises twice a week for 8 weeks. The intervention will not lead to progression, and the same intervention content will be used for 16 sessions. The exercises will be performed by a physical therapist. Receives: Other: Control |
| Intervention 1 | Experimental | Participants in this study will undergo exercises based on polyvagal theory twice a week for 8 weeks. The exercise content will be one set. The intervention will not be progressive, and the same intervention content will be used for 16 sessions. The intervention will be administered by a physical therapist. Receives: Other: Intervention 1 |
| Intervention 2 | Experimental | Participants in this study will receive exercises based on polyvagal theory in addition to traditional, painless cervical exercises twice a week for 8 weeks. Each exercise will be performed for 10 repetitions and 3 sets. Polyvagal theory-based exercises will be performed for 1 set. The intervention will be non-progressive and will use the same intervention content for 16 sessions. The intervention will be administered by a physical therapist. Receives: Other: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Joint Position Sense
Participants are asked to sit in a chair 90 cm from a white wall. A laser beam is fixed to their head. The laser light on the wall is marked as a reference point. Patients are then asked to turn their heads left and right, one at a time, to the end of the available range, then return to the original position with their eyes open and attempt to align the laser light with the reference point. Their eyes are then closed. As they return their heads to the original position, participants are asked to inform the examiner when they reach the original position. The new laser point on the wall is marked as the target point. Joint position error is calculated in degrees by dividing the arc tangent of the distance between the target and the reference point by 90 cm. The procedure is performed three times for each side for flexion, extension, right-left lateral flexion, and right-left rotation, and the average values of the errors for each side are used for further analysis.
Measured: Baseline and after 8 weeks of intervention
Secondary outcomes (6)
Visual Analog Scale
Neck pain is assessed using a 10-cm Visual Analog Scale. This scale is commonly used in clinical settings to evaluate the effectiveness of pain management. Participants indicate their current pain level by selecting a number between 0 (no pain) and 10 (unbearable pain) along a horizontal line. Previous studies report excellent test-retest reliability.
Measured: Baseline and after 8 weeks of intervention
Joint Range of Motion
Cervical active range of motion is assessed using a standard full-circle goniometer. Measurements are taken with participants seated comfortably in a neutral head position. For flexion and extension, the goniometer axis is placed over the external auditory meatus, the moving arm aligned with the nose, and the stationary arm vertical to the floor. Lateral flexion is measured with the axis on the C7 spinous process, the moving arm aligned with the occipital protuberance and dorsal midline of the head, and the stationary arm along the thoracic spinous processes. For right and left rotation, the axis is placed on the vertex of the head, the stationary arm parallel to a line connecting the acromial processes, and the moving arm directed toward the tip of the nose.
Measured: Baseline and after 8 weeks of intervention
Neck Disability Index (NDI)
Disability is assessed using the Neck Disability Index (NDI) questionnaire. The NDI consists of 10 questions, each with a possible score from 0 to 5. The total score of the 10 questions is divided by the highest possible score, 50, and expressed as a percentage. Higher percentage scores indicate greater disability. The NDI demonstrates good to excellent internal consistency, moderate to excellent reliability, and poor to good responsiveness. The minimum clinically important difference is reported as 20% in a similar cohort of people with chronic neck symptoms.
Measured: Baseline and after 8 weeks of intervention
Beck Depression Inventory (BDI)
his is a 21-item self-report scale that assesses depressive symptoms and attitudes. It provides a four-point Likert-type measurement. It provides information about the severity of depression. Its Turkish adaptation was conducted for reliability and validity by Hisli.
Measured: Baseline and after 8 weeks of intervention
Resting Heart Rate
Resting heart rate will be measured after each session using a smartwatch capable of measuring resting heart rate. Measurements will be taken 10 minutes after the exercise session, with patients sitting quietly with an empty bladder. During the measurement, participants will sit with their backs supported and their arms at a 90° angle. Measurements will be made twice, 15 minutes apart, and the average of these two measurements in beats per minute (bpm) will be used.
Measured: Immediately before and immediately after each treatment session (for 8 weeks)
WHOQOL-BREF
The WHOQOL-BREF is a tool used to assess psychometric properties. It consists of 26 questions related to four domains: physical health, psychological health, social relationships, and environment. Each item is rated on a 5-point Likert scale, with each score ranging from 0 to 100. Interclass correlation coefficients range from 0.71 to 0.91. The WHOQOL BREF is scored for domains. Domain scoring is positive. Higher facet scores indicate higher quality of life. The total raw score is multiplied by 4 to obtain a score comparable to the WHOQOL-100. The total is then converted to a 0-100 scale.
Measured: Baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start19 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- The study includes 3 different groups: control, intervention 1 and intervention 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mediha Uçan, Medipol University
- Investigators
- Dilanur Kutlu Özkaraoğlu, PhD, Principal investigator, Istanbul Medipol University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272551
- Sponsor's protocol ID
- IMU-FTR-MU-01
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of the Polyvagal Theory-based Exercise Approach in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT07272551
- Acronym / sponsor ID
- IMU-FTR-MU-01
- Conditions
- Chronic Neck Pain
- Keywords
- Neck Pain, chronic neck pain, Vagal Nerve Stimulation, Joint Position Sense, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Dec 2025 (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.
This study aimed to examine the effectiveness of a polyvagal theory-based exercise approach on joint position sense, pain, range of motion, functionality, depression, and quality of life in individuals with chronic neck pain.
H0 = The polyvagal theory-based exercise approach has no significant effect on joint position sense, neck pain, range of motion, functionality, depression, or quality of life.
H1 = The polyvagal theory-based exercise approach has a significant effect on joint position sense, neck pain, range of motion, functionality, depression, and quality of life.
Detailed description
Neck pain is one of the most common musculoskeletal problems that negatively impacts individuals' health and quality of life. When chronic painful conditions occur in musculoskeletal disorders, mood disorders such as depression and anxiety can also occur. A long-term history of neck pain is associated with stress, poor quality of life, and decreased functionality.
Polyvagal theory advocates working with the body, becoming aware of it, and connecting with the senses. Exercises based on polyvagal theory can be specifically designed and customized to stimulate the vagus nerve, promote relaxation, and enhance social interaction by following the principles of polyvagal theory.
While polyvagal theory is often used in psychology, it has only been used in rehabilitation in one study, with the potential to improve quality of life by inhibiting the sympathetic nervous system and activating the parasympathetic nervous system, thereby reducing pain perception and stress.
This study, in which participants were divided into three groups: control, intervention 1, and intervention 2, aimed to examine the effectiveness of a polyvagal theory-based exercise approach on joint position sense, pain, range of motion, functionality, depression, and quality of life in individuals with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study includes 3 different groups: control, intervention 1 and intervention 2.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlParticipants in this group will undergo traditional, painless cervical exercises twice a week for 8 weeks. The intervention will not lead to progression, and the same intervention content will be used for 16 sessions. The exercises will be performed by a physical therapist. |
| Intervention 1 | Experimental | Other: Intervention 1Participants in this study will undergo exercises based on polyvagal theory twice a week for 8 weeks. The exercise content will be one set. The intervention will not be progressive, and the same intervention content will be used for 16 sessions. The intervention will be administered by a physical therapist. |
| Intervention 2 | Experimental | Other: Intervention 2Participants in this study will receive exercises based on polyvagal theory in addition to traditional, painless cervical exercises twice a week for 8 weeks. Each exercise will be performed for 10 repetitions and 3 sets. Polyvagal theory-based exercises will be performed for 1 set. The intervention will be non-progressive and will use the same intervention content for 16 sessions. The intervention will be administered by a physical therapist. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with chronic neck pain of Grade 1 or 2, lasting at least 3 months
- Individuals whose pain is clinically evaluated and diagnosed
- Individuals with a pain score of 3 or higher on the Visual Analog Scale
Key exclusion criteria (9 listed)
- Individuals diagnosed with chronic neck pain of Grade 3 or 4
- History of trauma or surgical intervention in the neck region
- Cervical disc herniation, cervical stenosis, or other serious neurological conditions
- Upper extremity radiculopathy
- Acute inflammation or infection
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 |
|---|---|---|
| ControlParticipants in this study will undergo traditional, painless cervical exercises twice a week for 8 weeks. Each exercise will be performed for 10 repetitions and 3 sets. The exercises are as follows: Traditional, painless cervical exercises will consist of 10 slow repetitions of each of the following cervical movements, starting from a natural resting head position: left rotation, right rotation, flexion, extension, left lateral flexion, and right lateral flexion. Isometric neck exercises will be performed in a straight line forward, backward, right, and left direction, with the patient's own hands providing resistance in the opposite direction. Shoulder active ROM exercises will involve participants performing shoulder flexion, abduction up to 90°, and external and internal rotation exercises with their elbows flexed to 90° and their arms at their sides. Additionally, they will be asked to perform shoulder rolls forward and backward while standing. | Other | Control |
| Intervention 1In this study, participants will undergo polyvagal theory-based exercises twice a week for 8 weeks, totaling 16 sessions. The exercises are categorized into four main groups: sensory awareness exercises, progressive muscle relaxation, vocalization exercises, and self-soothing touch exercises. Sensory awareness exercises include focused breathing, awareness of upright postures and bodily sensations, lying on the back with eyes closed while focusing on positive thoughts, and walking mindfully in a calm environment. Progressive muscle relaxation involves sequentially tensing and relaxing muscle groups from the toes to the head and visualizing calming scenes through guided imagery. Vocalization exercises consist of tongue trills producing a "ben" sound, humming with a closed mouth, and sustaining vowel sounds. Self-soothing touch exercises include massaging the feet, mindfully touching the arms, face, and palms, and practicing abdominal breathing. | Other | Intervention 1 |
| Intervention 2Participants in this study will receive exercises based on polyvagal theory in addition to traditional, painless cervical exercises twice a week for 8 weeks. Each exercise will be performed for 3 sets of 10 repetitions. Participants will rest for two seconds after each repetition and five seconds after each set. The exercise content will be the same as described above. One set of polyvagal theory-based exercises will be performed. The exercise content will be the same as described above. The intervention will not be progressive, and the same intervention content will be used for 16 sessions. The intervention will be administered by a physiotherapist. | Other | Intervention 2 |
Primary outcome
Cervical Joint Position Sense
Time frame: Baseline and after 8 weeks of intervention
Participants are asked to sit in a chair 90 cm from a white wall. A laser beam is fixed to their head. The laser light on the wall is marked as a reference point. Patients are then asked to turn their heads left and right, one at a time, to the end of the available range, then return to the original position with their eyes open and attempt to align the laser light with the reference point. Their eyes are then closed. As they return their heads to the original position, participants are asked to inform the examiner when they reach the original position. The new laser point on the wall is marked as the target point. Joint position error is calculated in degrees by dividing the arc tangent of the distance between the target and the reference point by 90 cm. The procedure is performed three times for each side for flexion, extension, right-left lateral flexion, and right-left rotation, and the average values of the errors for each side are used for further analysis.
6 secondary outcomes
Visual Analog Scale
Time frame: Baseline and after 8 weeks of intervention
Joint Range of Motion
Time frame: Baseline and after 8 weeks of intervention
Neck Disability Index (NDI)
Time frame: Baseline and after 8 weeks of intervention
Beck Depression Inventory (BDI)
Time frame: Baseline and after 8 weeks of intervention
Resting Heart Rate
Time frame: Immediately before and immediately after each treatment session (for 8 weeks)
WHOQOL-BREF
Time frame: Baseline and after 8 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Dilanur Kutlu Özkaraoğlu, PhD principal investigator
Istanbul Medipol University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 and Intervention 2 in people with Chronic Neck Pain, run by Medipol University at 1 site 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 3 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Cervical Joint Position Sense (time frame: Baseline and after 8 weeks of intervention). 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 17 Mar 2026.