Comparison of Pain, Sensitisation, Function and Quality of Life According to Stenosis Degree in Chronic Neck Pain

NCT06967415 | Not Yet Recruiting

• 1 other identifier: Central Sensitisation-35
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spine Stenosis; Central Sensitisation

Keywords

chronic neck pain

Outcome Measures

Primary Outcomes (8)

• The assessment of pain.

  A Visual Analog Scale (VAS) will be used for pain assessment. The scale is 100 mm in length, with the words "no pain" and "the worst imaginable pain" fixed at the left and right ends. Individuals are asked to draw a vertical mark along the horizontal line that best represents their pain level. VAS is a widely used assessment method with good reliability and validity.

  Immediately after the stenosis grade is determined through MRI

• Central Sensitization Inventory (CSI)

  The Central Sensitization Inventory (CSI) will be used to assess central sensitization. This scale consists of a total of 25 items related to central sensitization symptoms, and participants are asked to mark a response ranging from "always" (four points) to "never" (zero points) for each item. The total score obtained from the scale ranges from 0 to 100, with a score of 40 or higher indicating the presence of central sensitization.

  Immediately after the stenosis grade is determined through MRI

• Pressure Pain Threshold (PPT) Measurement

  Pressure pain threshold measurement is a method performed using an algometer. In this method, the tip of the device is placed perpendicular to the area to be measured, and pressure is gradually increased. Measurements will be made bilaterally, and the areas to be measured include the Upper Trapezius muscle, Sternocleidomastoid muscle, and Cervical Erector Spinae muscle. The first pressure value at which the patient feels pain is recorded in kg/cm². This method is considered more economical and reliable compared to quantitative sensory tests.

  Immediately after the stenosis grade is determined through MRI

• Semmes-Weinstein Monofilament (SWM) Test

  The Semmes-weinstein monofilament test is one of the aesthesiometry tests used to evaluate tactile sensation in the clinical setting. It is tested with nylon monofilaments of approximately 38mm and varying diameters. The person is prevented from seeing the evaluation area and the person is explained how the test will be performed. In the area where the monofilament will be applied, pressure is applied to the skin in a perpendicular position (90⁰C angle) until the monofilament bulges. It is kept for 1.5 seconds in each region and the monofilament is removed from the skin after it is restored. The individual is asked to indicate 'yes' when he/she feels the stimulus on the skin. A maximum of 3 times stimulus is given in monofilaments from 1,65 to 4,08. For monofilaments from 4.17 to 6.65, 1 stimulus is given. If there is no response to the stimulus, the next filament is selected.

  Immediately after the stenosis grade is determined through MRI

• Copenhagen Neck Functional Disability Scale

  The scale, consisting of 15 items, measures the effects of neck pain (Jordan et al., 1998). In the scoring of the scale, points ranging from 0 to 2 are given based on the responses "Yes," "No," and "Sometimes." The maximum score that can be obtained from the scale is 30 points.

  Immediately after the stenosis grade is determined through MRI

• Assessment of Normal Joint Range of Motion

  Cervical region normal joint range of motion (ROM) will be assessed using the Pa Crom Basic - Cervical Range Of Motion (CROM) device. The CROM device is highly reliable for evaluating cervical joint range of motion. The device will be securely fixed to the patient's head using Velcro. Patients will be seated on a chair with their feet flat on the ground. The dial on the CROM will be set to the 0 position in the plane of the movement to be measured, and the correct movement technique will be taught to the patients. The patient will be asked to actively perform flexion, extension, right-left rotation, and right-left lateral flexion movements. Each movement will be repeated three times, and passive joint range of motion will be assessed. The average of the test values will be recorded.

  Immediately after the stenosis grade is determined through MRI

• Proprioceptive Sensory Assessment

  It will be assessed using the CROM device. Repositioning to a neutral head position (Joint Position Error - EPH) Repositioning the head to a predetermined reference point (Head Repositioning Accuracy - BYPD). For the BYPD test, the patient is asked to move the head to the target position. Deviations of 3-4 degrees from the target point indicate impaired joint position sense. patient sits upright. The CROM device is placed on the patient's head with velcro. Deviations in the dials on the CROM device are recorded. For the BYPD test, half of the measured maximum active range of motion is set as the target position. With the patient's eyes closed, the head is slowly moved to the target position and perceived. Then the head is moved in the opposite direction and the patient actively brings the head to this position. Measurements are made 3 times and the average deviation is recorded. Measurements are made for flexion, extension, right-left rotation and right-left lateral flexion.

  Immediately after the stenosis grade is determined through MRI

• Quality of Life Assessment

  The Short Form-36 (SF-36) will be used. This questionnaire examines 8 dimensions of health with 36 items. These dimensions include social functioning, physical functioning, physical role limitations, energy, mental health, emotional role limitations, general health perception, and pain. When there are no limitations or disabilities, the highest possible score of 100 is obtained. Each dimension is evaluated independently, and a higher score indicates a higher quality of life for that dimension.

  Immediately after the stenosis grade is determined through MRI

Study Arms (4)

degree of cervical stenosis 0

OTHER

Patients with a stenosis grade of 0 according to the Kang grading system in MRI imaging

Other: Pain, central sensitization,functional status and quality of life.

degree of cervical stenosis 1

OTHER

Patients with a stenosis grade of 1 according to the Kang grading system in MRI imaging

Other: Pain, central sensitization,functional status and quality of life.

degree of cervical stenosis 2

OTHER

Patients with a stenosis grade of 2 according to the Kang grading system in MRI imaging

Other: Pain, central sensitization,functional status and quality of life.

degree of cervical stenosis 3

OTHER

Patients with a stenosis grade of 3 according to the Kang grading system in MRI imaging

Other: Pain, central sensitization,functional status and quality of life.

Interventions

Pain, central sensitization,functional status and quality of life. OTHER

The patients' pain status, central sensitization functional status, and quality of life will be evaluated according to their stenosis grade.

degree of cervical stenosis 0; degree of cervical stenosis 1; degree of cervical stenosis 2; degree of cervical stenosis 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Central Nervous System Sensitization; Functional Status; Quality of Life

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Onur Engin, Assist Prof

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferruh Taspinar, Prof. Dr.

CONTACT

05426853877; fztferruh@hotmail.com

Meltem Sevgili, Pt.

CONTACT

05456705454; meltemsevgili23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: December 15, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)