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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cases whose stenosis classification can be clearly determined on MRI

Individuals with neck pain for at least 3 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

88 Participants
are divided into 4 treatment groups
Group A: degree of cervical stenosis 0Other 1 intervention
Group B: degree of cervical stenosis 1Other 1 intervention
Group C: degree of cervical stenosis 2Other 1 intervention
Group D: degree of cervical stenosis 3Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after the stenosis grade is determined through MRI
2

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.

Time frame
Immediately after the stenosis grade is determined through MRI
3

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.

Time frame
Immediately after the stenosis grade is determined through MRI
4

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.

Time frame
Immediately after the stenosis grade is determined through MRI

Secondary outcomes

Other outcomes

Sponsors and contacts

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