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NCT Number: NCT06544850

Lateralization Performance in Chronic Low Back Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

experimental group

Other

Oswestry Low Back Pain Questionnaire will be used to assess functional limitations in daily life activities of patients with low back pain. Recognize mobile application will be used to assess lateralization performance. Evaluation will be made with hand, foot and back modules of this application. 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. Visual Analog Scale (VAS) will be used to measure general pain status of patients. Tampa Kinesiophobia Scale will be used to assess fear of movement. Pain catastrophizing level will be assessed with Pain Catastrophizing Scale. Two-point discrimination device will be used to assess two-point discrimination. Central Sensitization Inventory will be used for central sensitization findings.

Control Group

Other

Healthy volunteer participants who meet the inclusion criteria will be evaluated with the tests applied to the experimental group

Primary outcomes

  1. Lateralization Performance

    Time frame: 4 months

    The Recognize mobile application will be used to evaluate lateralization performance. The evaluation will be made with the hand, foot and back modules of this application. The photos will be shown on a screen. If the photo is from the right side, the person will press the right button and if it is from the left side, the person 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

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: 4 months

    Oswestry Low Back Pain Questionnaire will be used to evaluate functional limitations in daily life activities of patients with low back pain. This questionnaire has 6 sections with scores ranging from 0 to 5 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

  2. Visual Analogue Scale

    Time frame: 4 months

    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)

  3. Tampa Scale of Kinesiophobia

    Time frame: 4 months

    The Tampa Kinesiophobia Scale will be used to assess 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) strongly disagree, (2) disagree, (3) agree, and (4) 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 the different items can vary between 17-68.

  4. Central Sensitization inventory

    Time frame: 4 months

    For central sensitization findings, the Central Sensitization Inventory will be used. Part A, consisting of 25 items scored from 0 to 4, will be used. A higher score indicates the presence of more symptoms associated with central sensitization. A cut-off value equal to or above 40 indicates the presence of central sensitization

  5. Pain Catastrophizing Scale

    Time frame: 4 months

    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

  6. Two Point Discrimination

    Time frame: 4 months

    A two-point discrimination device will be used to evaluate two-point discrimination

Study contacts

Contact information is provided by the study sponsor or research team.

CANDİRİ

CONTACT

[email protected]

04223410220

yüksel

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Lateralization Performance and Two-point Discrimination in Patients With Chronic Low Back Pain: A Cross-sectional Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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