NCT06544850

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 5, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

painrehabilitationlateralization

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Secondary Outcomes (6)

  • Oswestry Disability Index

    4 months

  • Visual Analogue Scale

    4 months

  • Tampa Scale of Kinesiophobia

    4 months

  • Central Sensitization inventory

    4 months

  • Pain Catastrophizing Scale

    4 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: control group

Interventions

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.

Experimental Group

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

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy individuals and participants with chronic low back pain

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25783221BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • YÜKSEL

    Assistant researcher

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 9, 2024

Study Start

August 10, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share