Assessment of All Spine Segments ın Individuals With Low Back Pain

March 6, 2024 updated by: Sumeyye Zehra Guler, Hacettepe University

Assessment and Comparison of All Spinal Segments Kinematics ın Patients With Chronic Low Back Pain and Asymptomatic Individuals ın Three Planes During Activities of Daily Living

The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low back pain is an important global health problem, with 84% of the population having at least one episode of low back pain in their lifetime and 23% developing a chronic form. It has been shown in many studies that the quality of life of individuals with low back pain is seriously reduced due to problems such as depression, anxiety, attention problems, sleep disorders, and social isolation. Low back pain has serious negative effects on national economies all over the world due to incapacity and increased medical expenses. According to the International Classification System of Health, individuals with low back pain often evaluated activities such as maintaining body position, changing basic body position, lifting objects, and walking as painful in their daily lives. Studies show that patients exhibit maladaptive spinal movement strategies that include increased trunk muscle activity and decreased trunk mobility to prevent further pain or injury during these activities. It was concluded that there was no difference in lordosis angles in people with low back pain compared to healthy controls, but there was a decrease in the lumbar range of motion in all directions of motion and they moved more slowly. It is seen that most of the studies focus only on the lumbar spine while evaluating functional activities, while other segments of the spine are ignored. The limited number of studies examining other segments concluded that the angle changes did not occur only in the lumbar spine and emphasized the importance of examining other segments together. For example, in a study conducted in individuals with low back pain and healthy individuals, it was found that during the task of step-up with three different step heights, patients exhibited more extension and less flexion in the upper thoracic joints in the sagittal plane, and it was recommended to examine the head movements in future studies. The same study also noted smaller lower thoracic and upper lumbar range of motion in patients in the frontal plane. According to these results, it can be said that examining functional activities in only one plane is insufficient due to the multifaceted nature of movement in individuals with low back pain. Defining spinal angles in different planes, examining different functional activities, and evaluating the spine as a whole are necessary to understand and effectively rehabilitate the changing spinal kinematics in low back pain. With the developing technology, many kinematic analysis methods have emerged to analyze the movement of body segments. Among these, Inertial Measurement Sensors have become effective tools for objective and quantitative evaluation due to their low cost, accuracy and portability. According to this information, in this study, it aim to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls while performing the tasks that patients with chronic low back pain often describe as painful in their daily lives, using these sensors that provide valid and reliable results for the kinematic analysis of functional activities. At the end of the study, it is expected that the motion patterns of the cervical, upper-lower thoracic, and upper-lower lumbar segments in 3 planes may differ kinematically in individuals with low back pain compared to healthy individuals, and the movement of the lumbar region in 3 planes may be affected by cervical and/or thoracic region movement. These results will guide the understanding of multifactorial low back pain and will enable the determination and implementation of appropriate preventive and therapeutic strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06050
        • Recruiting
        • Hacettepe University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

For the low back pain group:

  • Individuals aged 18-55 with non-specific chronic low back pain
  • Individuals who have been experiencing pain for more than 3 months
  • Individuals whose pain intensity is above 3 on the Visual Analog Scale

For the healthy group:

- Individuals aged 18-55 with no history of low back pain lasting more than 1 week for 6 months prior to the study

Exclusion Criteria:

  • Current rheumatological or neurological diseases
  • Recent or current pregnancy
  • History of tumors or spine fractures
  • Known spinal defects or surgery history
  • Body mass index over 30 kg/m²

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Back Pain Group
Low back pain group will be evaluated the kinematics of all spine segments in 3 planes while performing the tasks that patients with chronic low back pain often describe as painful in their daily lives,
Other: Low back pain group
The low back pain group will be evaluated the kinematics of all spine segments in 3 planes while performing the tasks that patients with chronic low back pain often describe as painful in their daily lives such as walking, stepping up, standing up, bending and lifting. Using Inertial Measurement Sensors that provide valid and reliable will evaluate the kinematics of all spine
Active Comparator: Healthy Group
Healthy Group's results will be compared them with low back pain group
Other: Healthy group
Low back pain kinematics compare them with asymptomatic kontrols

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the kinematics of the all spine during walking
Time Frame: two months
Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for walking. Angular data in the atlanto-occipital, C7-T1, T8-T9, T12-L1, L3-L4, and L5-S1 segments will be recorded in 3-dimensional. Participants will walk on a 10-meter walking path.
two months
Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects
Time Frame: two months
Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for Bending Forward and Lifting Objects. The box (5 kilograms ) will be centered 15 centimeter in front of the participants' toes. Spinal kinematics will be analyzed from bending forward to lift the box, to holding the box in front of the hips and standing straight.
two months
Evaluation of the kinematics of the all spine during Standing from Sitting
Time Frame: two months
Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for Standing from Sitting. Participants will stand up with their arms crossed over their chest at their preferred pace.
two months
Evaluation of the kinematics of the all spine during Climbing Step
Time Frame: two months
Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for Climbing Step. Each participant will be asked to step onto a single 24 centimeter tall rectangular step placed ~13 centimeter from the big toe at a self-selected pace
two months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spine Normal Joint Movement evaluation
Time Frame: two months
Lumbar Spine Normal Joint Movement of Flexion, Extension, Lateral Flexion and Rotation movements will be evaluated by goniometric measurement.
two months
Pain intensity: Visual Analog Scale
Time Frame: two months
It is one of the pain rating scales. The pain Visual Analog Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions.It is a straight horizontal line of fixed length, usually 100 milimeters. The ends are defined as the extreme limits of the parameter to be measured(pain) oriented from the left (worst) to the right (best).
two months
Oswestry Disability Index
Time Frame: two months
It is an important tool that researchers use to measure a patient's permanent functional disability. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The higher scores indicate an increasing degree of disability.
two months
Fear of movement: Tampa Kinesiophobia Scale
Time Frame: two months
It is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item Tampa total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sümeyye Zehra Güler, MSc, +90 5079320390

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HU-FTR-SZK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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