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临床试验/NCT07272551
NCT07272551Enrolling By Invitation不适用

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

Medipol University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年7月19日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
33
试验地点
1
主要终点
Cervical Joint Position Sense

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Control (Other)

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.

干预措施: Intervention 1 (Other)

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.

干预措施: Intervention 2 (Other)

结局指标

主要结局

Cervical Joint Position Sense

时间窗: 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.

次要结局

  • 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))
  • WHOQOL-BREF(Baseline and after 8 weeks of intervention)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mediha Uçan

Physiotherapist

Medipol University

研究点 (1)

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