Chronic Low-back PainNCT06544850
Lateralization Performance in Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by Inonu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- experimental group
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy individuals and participants with chronic low back pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
yüksel contact
About this study
Official title: Lateralization Performance and Two-point Discrimination in Patients With Chronic Low Back Pain: A Cross-sectional Study
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- experimental group, control group
- Keywords
- pain, rehabilitation, lateralization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupOther
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 groupOther
Healthy volunteer participants who meet the inclusion criteria will be evaluated with the tests applied to the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Participants Individuals between 18-65 will be included in the study because pain mechanisms and effects are different between adults and children. Inclusion criteria are having low back pain for 3 months or longer, Mini mental test score>23, Healthy individuals who do not experience chronic low back pain will be evaluated in the control group. Hypertension, congestive heart failure, chronic obstructive pulmonary disease, rheumatological diseases, vertigo, nausea, vomiting, specific diagnosis underlying back pain (e.g. radicular symptoms), significant decrease in vision and hearing, body mass index higher than 30, serious psychiatric condition, inability to communicate, traumatic low back pain, those who have had back surgery, those who refused to participate in the study and did not fill out the consent form will be excluded. Receives: Other: experimental group | |
| Control Group | Consists of healthy volunteer participants who meet the inclusion criteria. The control group will be selected from those who have never felt back pain that would affect their daily life activities and who have not received treatment. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateralization Performance
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
Measured: 4 months
Secondary outcomes (6)
Oswestry Disability Index
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
Measured: 4 months
Visual Analogue Scale
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)
Measured: 4 months
Tampa Scale of Kinesiophobia
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.
Measured: 4 months
Central Sensitization inventory
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
Measured: 4 months
Pain Catastrophizing Scale
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
Measured: 4 months
Two Point Discrimination
A two-point discrimination device will be used to evaluate two-point discrimination
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BÜŞRA CANDİRİ, Inonu University
- Investigators
- YÜKSEL, Principal investigator, Assistant researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544850
- Sponsor's protocol ID
- 2024/6004
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25783221
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateralization Performance and Two-point Discrimination in Patients With Chronic Low Back Pain: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06544850
- Acronym / sponsor ID
- 2024/6004
- Conditions
- Chronic Low-back Pain
- Keywords
- pain, rehabilitation, lateralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Other: experimental groupParticipants Individuals between 18-65 will be included in the study because pain mechanisms and effects are different between adults and children. Inclusion criteria are having low back pain for 3 months or longer, Mini mental test score>23, Healthy individuals who do not experience chronic low back pain will be evaluated in the control group. Hypertension, congestive heart failure, chronic obstructive pulmonary disease, rheumatological diseases, vertigo, nausea, vomiting, specific diagnosis underlying back pain (e.g. radicular symptoms), significant decrease in vision and hearing, body mass index higher than 30, serious psychiatric condition, inability to communicate, traumatic low back pain, those who have had back surgery, those who refused to participate in the study and did not fill out the consent form will be excluded. |
| Control Group | – | Other: control groupConsists of healthy volunteer participants who meet the inclusion criteria. The control group will be selected from those who have never felt back pain that would affect their daily life activities and who have not received treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy individuals and participants with chronic low back pain
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupOswestry 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. | Other | Experimental Group |
| control groupHealthy volunteer participants who meet the inclusion criteria will be evaluated with the tests applied to the experimental group | Other | Control Group |
Primary outcome
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
6 secondary outcomes
Oswestry Disability Index
Time frame: 4 months
Visual Analogue Scale
Time frame: 4 months
Tampa Scale of Kinesiophobia
Time frame: 4 months
Central Sensitization inventory
Time frame: 4 months
Pain Catastrophizing Scale
Time frame: 4 months
Two Point Discrimination
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 25783221Tsay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yüksel contact
YÜKSEL principal investigator
Assistant researcher
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CANDİRİ (04223410220, candiri_17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateralization Performance (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06544850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.