The Effectiveness of the Polyvagal Theory in Chronic Neck Pain

NCT07272551 | Enrolling By Invitation

• 1 other identifier: IMU-FTR-MU-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Keywords

Neck Pain; chronic neck pain; Vagal Nerve Stimulation; Joint Position Sense; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 8 weeks of intervention

Secondary Outcomes (6)

• Visual Analog Scale

  Baseline and after 8 weeks of intervention

• Joint Range of Motion

  Baseline and after 8 weeks of intervention

• Neck Disability Index (NDI)

  Baseline and after 8 weeks of intervention

• Beck Depression Inventory (BDI)

  Baseline and after 8 weeks of intervention

• Resting Heart Rate

  Immediately before and immediately after each treatment session (for 8 weeks)

Study Arms (3)

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.

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.

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.

Other: Intervention 2

Interventions

Control 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.

Control

Intervention 1 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 1

Intervention 2 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.

Intervention 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Noi 6:15 studio

Istanbul, Maltepe, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Dilanur Kutlu Özkaraoğlu, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The study includes 3 different groups: control, intervention 1 and intervention 2.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: July 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)