The Effectiveness of the Polyvagal Theory in Chronic Neck Pain

NCT ID: NCT07272551

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-19
• Study Completion Date: 2026-01-30

Brief 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.

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.

Conditions

Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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 1

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.

Group Type: EXPERIMENTAL

Intervention 1

Intervention Type: OTHER

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 2

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.

Group Type: EXPERIMENTAL

Intervention 2

Intervention Type: OTHER

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.

Interventions

Control

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 Type: OTHER

Intervention 1

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 Type: OTHER

Intervention 2

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Mediha Uçan

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilanur Kutlu Özkaraoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medipol University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Locations

Noi 6:15 studio

Istanbul, Maltepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IMU-FTR-MU-01

Identifier Type: -

Identifier Source: org_study_id