Clinical trial NCT06967415: Comparison of Pain, Sensitisation, Function and Quality of Life According to Stenosis Degree in Chronic Neck Pain
Official title: Comparison of Pain, Central Sensitisation, Functional Status and Quality of Life According to Stenosis Degree in Individuals With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Sensitisation
Cervical Spine Stenosis
Keywords: chronic neck pain
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The cervical spine is a structure that bears the weight of the head and has important functions, but is susceptible to mechanical stress and degenerative processes. Cervical stenosis can lead to compression of the nerve roots as a result of narrowing of the spinal canal and symptoms such as pain, numbness and weakness. Central sensitisation (CS) causes even innocuous stimuli to cause pain due to hypersensitivity of the central nervous system and negatively affects the quality of life by increasing pain intensity in individuals with chronic neck pain. Progression of cervical stenosis can lead to symptoms such as walking difficulties, loss of balance and loss of proprioception. Furthermore, CS causes patients to avoid physical activity, increasing muscle weakness and pain, which further reduces quality of life. For this reason, our study will be carried out to determine the effect of cervical stenosis on patients with neck pain whom applied to Izmir Democracy University Physical Medicine and Rehabilitation outpatient clinic and had cervical MRI. Participants' pain status, central sensitisation, sensory loss, range of motion and proprioception will be recorded. Pressure pain threshold will be measured with algometer, sensory loss will be examined with Semmes-Weinstein Monofilament (SWM) Test, joint movements and proprioception will be evaluated with Pa CROM Basic device. In addition, the effects of cervical stenosis on functional status and quality of life will be measured by questionnaires. The data obtained will be compared and analysed with appropriate statistical methods. This study is aimed to contribute to the development of treatment methods and improvement of patient care, and will provide important information in terms of pain management and improvement of quality of life.

Detailed description: The cervical spine is a critical structure that carries the entire weight of the head and protects the spinal cord, nerve roots and vertebral arteries. Since it is the most mobile part of the spine, it is the most exposed to mechanical stress, degenerative changes and trauma. Degenerative processes occurring in the cervical spine lead to conditions such as cervical spondylosis, cervical degenerative disc disease/disc herniation and cervical spondylotic myopathy, causing narrowing of the cervical spinal canal. A narrower than normal cervical spinal canal is defined as cervical spinal stenosis. In a study by Melancia et al., the researchers reported thatthe incidence of spinal stenosis is high in individuals aged 65 years and over, and that this condition may lead to symptoms such as pain, numbness, weakness, motor and sensory disorders as a result of compression of nerve roots.Neck pain is one of the most common musculoskeletal pathologies today. Global surveys show that a large proportion of the population experiences neck pain at some point in their lives. It is estimated that 50-85% of individuals with this condition will experience chronic pain within five years. Monticone et al. found that chronic neck pain has negative effects on quality of life as well as affecting activities of daily living. Chronic neck pain not only negatively affects the quality of life of individuals, but also imposes a serious burden on the health system.Neck pain is divided into different categories depending on its duration. If the pain persists for less than 6 weeks, it is considered acute neck pain. When the duration of pain is less than three months, it is classified as subacute neck pain, and when it lasts between three and six months, it is classified as chronic neck pain.There are many risk factors and causes that can lead to neck pain, such as poor posture, female gender and old age.Neck pain is a multifactorial condition with a variety of symptoms including decreased range of motion, asthenia, hyperalgesia and tension in superficial and deep neck muscles. With prolonged persistence of pain, some structural and sensory changes may occur in the central nervous system (CNS). These changes lead to increased stimulation of nociceptors and create an environment for the development of central sensitisation (CS). The International Association for the Study of Pain (IASP) defines central sensitisation (CS) as 'increased sensitivity of nociceptive neurons in the central nervous system to normal or subthreshold afferent inputs.Central sensitisation is a condition that occurs when pain transmission pathways are subjected to hypersensitivity. This process leads to an exaggerated perception of painful stimuli (hyperalgesia) and the perception of even harmless stimuli as pain (allodynia). However, central sensitisation plays a critical role in the development of reflected pain and hyperalgesia in multiple spinal segments. This mechanism triggers over-activation of the central nervous system, making individuals' pain experiences more intense. In this context, understanding central sensitisation is crucial for the development of chronic pain treatment strategies. Central sensitisation contributes tounderstand why individuals with musculoskeletal disorders experience pain, disability and other symptoms even in the absence of obvious nociceptive stimulation or tissue damage and in many diseases associated with chronic pain.While the existence of central sensitisation in chronic neck pain was the subject of debate in a study by Malfliet et al. in 2020, Roldán-Jiménez et al. observed that central sensitisation has a significant effect in different pain populations. The researchers found that central sensitisation is common especially among individuals with low back and neck pain.In a study conducted by Abdon et al. in 2024, indicated thatcentral sensitisation (CS) was more common in female individuals with chronic neck pain compared to male individuals with chronic neck pain. The symptoms associated with central sensitisation (CS) can increase the burden on health by complicating the treatment of patients and are therefore of great clinical importance. Studies have shown that patients with SS experience higher pain intensity, longer duration of pain, increased disability and decreased quality of life. The decline in functional status of individuals becomes more pronounced with increasing severity of CS.Although pain, functional status and quality of life are often assessed in individuals with cervical stenosis, there is a significant gap in the literature regarding the role of central sensitisation in these patients. Central sensitisation refers to an increased sensitivity of the central nervous system to pain and is known to be a pathological mechanism associated with chronic pain. However, studies on the presence and effects of central sensitisation in degenerative spine diseases such as cervical stenosis are limited. This deficiency represents a critical gap in the understanding of how to improve treatment strategies for patients with cervical stenosis. Evaluation of central sensitisation may provide a new perspective in the pain management of these patients and allow the development of more targeted treatment approaches. Therefore, our study was planned to examine the effects of the degree of cervical stenosis on central sensitisation, functional status and quality of life in individuals with chronic neck pain.

Eligibility criteria: Inclusion Criteria:

* Cases whose stenosis classification can be clearly determined on MRI
* Individuals with neck pain for at least 3 months

Exclusion Criteria:

* Individuals who did not agree to participate in the study
* Individuals undergoing cervical surgery
* Individuals with pain so severe that they cannot perform cervical movement
* Individuals with a diagnosis of vertigo
* Individuals with sudden hearing loss
* Individuals with additional neurological disorders
* Individuals with psychiatric and cognitive disorders that would prevent measurement in the study

Primary outcomes:
measure: The assessment of pain.
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Central Sensitization Inventory (CSI)
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Pressure Pain Threshold (PPT) Measurement
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Semmes-Weinstein Monofilament (SWM) Test
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Copenhagen Neck Functional Disability Scale
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Assessment of Normal Joint Range of Motion
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Proprioceptive Sensory Assessment
timeFrame: Immediately after the stenosis grade is determined through MRI
measure: Quality of Life Assessment
timeFrame: Immediately after the stenosis grade is determined through MRI
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: Onur Engin, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References: