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Enrolling by invitation NCT07272551

The Effectiveness of the Polyvagal Theory in Chronic Neck Pain

No phase Interventional Chronic Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control, Intervention 1, Intervention 2.
Who it may be relevant to
Registry conditions: Chronic Neck Pain. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of the Effectiveness of the Polyvagal Theory-based Exercise Approach in Chronic Neck Pain

Overview

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.

Interventions

  • Other 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
  • 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
  • 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 in

Primary outcome measures

  • Cervical Joint Position Sense [Time frame: Baseline and after 8 weeks of intervention]
Secondary outcome measures (6)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Noi 6:15 studio — Istanbul

Identifiers

NCT: NCT07272551 · IMU-FTR-MU-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗