Clinical trial NCT06544850: Lateralization Performance in Chronic Low Back Pain
Official title: Lateralization Performance and Two-point Discrimination in Patients With Chronic Low Back Pain: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Low-back Pain
Keywords: pain
rehabilitation
lateralization
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy individuals and participants with chronic low back pain

Brief summary: The aim of our study was to examine the relationship between lateralization performance, two-point discrimination, kinesiophobia and pain catastrophizing in patients with chronic low back pain.

Detailed description: Participants who meet the inclusion criteria and agree to participate in the study will be selected from the relevant population by the improbable random sampling method. Demographic data, age, gender, height, weight), education status, and dominant hand and foot information will be obtained from the volunteer participants participating in the study before starting the study. Oswestry Low Back Pain Questionnaire will be used to evaluate functional limitations in daily life activities of patients experiencing low back pain. This questionnaire has 6 sections with 0-5 points for each question. It consists of 10 sections including pain intensity, personal precautions, lifting objects, walking, sitting, standing, sleeping, sexual life, social life, and travel. 0-4 points are considered as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe, and 35-50 points as complete disability. The minimum score received from the scale is 0 and the maximum score is 50. A score of 50 indicates the highest level of functional disability . Recognize mobile application will be used to evaluate lateralization performance. This application will be evaluated with the hand, foot and back modules. The photographs will be shown on a screen. If the patient thinks the photo belongs to the right side, the patient will press the right button and if the patient thinks the photo belongs to the left side, the patient will press the left button. The reaction time and accuracy given at the end of the application will be recorded. The most accurate response instruction will be given in the shortest possible time. The Visual Analog Scale (VAS) will be used to measure the general pain status of the patients. In addition, the duration of the pain, the localization of the pain (right, left) and the Tampa Kinesiophobia Scale will be used to evaluate the fear of movement. This scale consists of 17 items. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. Each item is scored on a 4-point Likert scale (1-4). The answers and their numerical values are as follows: (1) I strongly disagree, (2) I disagree, (3) I agree and (4) I strongly agree. The scores of items 4, 8, 12 and 16 should be reversed when calculating the total score. The total score obtained by adding different items can vary between 17-68. The level of pain catastrophizing will be assessed with the Pain Catastrophizing Scale. This scale is a 5-point Likert-type scale consisting of 13 questions and evaluates the feelings and thoughts of the person when experiencing pain. A two-point discrimination device will be used to assess two-point discrimination. The Central Sensitization Inventory will be used for central sensitization findings. Part A, consisting of 25 items scored from 0 to 4, will be used. A higher score indicates the presence of more symptoms related to central sensitization. A cut-off value equal to or above 40 indicates the presence of central sensitization.

Eligibility criteria: Inclusion Criteria:

* Having low back pain for 3 months or longer
* Mini mental test score\>23
* Healthy individuals in the control group who do not have chronic low back pain

Exclusion Criteria:

* Hypertension
* chronic obstructive pulmonary disease
* specific diagnosis underlying back pain (e.g. radicular symptoms)
* inability to communicate
* those who refused to participate in the study and did not fill out the consent form

Primary outcomes:
measure: Lateralization Performance
timeFrame: 4 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 4 months
measure: Visual Analogue Scale
timeFrame: 4 months
measure: Tampa Scale of Kinesiophobia
timeFrame: 4 months
measure: Central Sensitization inventory
timeFrame: 4 months
measure: Pain Catastrophizing Scale
timeFrame: 4 months
measure: Two Point Discrimination
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistant researcher
name: YÜKSEL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsay A, Allen TJ, Proske U, Giummarra MJ. Sensing the body in chronic pain: a review of psychophysical studies implicating altered body representation. Neurosci Biobehav Rev. 2015 May;52:221-32. doi: 10.1016/j.neubiorev.2015.03.004. Epub 2015 Mar 14.