Low Back PainNCT06276322
Assessment of All Spine Segments ın Individuals With Low Back Pain
A study testing Low back pain group and Healthy group in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Low back pain group and Healthy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe university
Ankara, Altındağ, 06050
Sümeyye Zehra Güler, MSc, 5079320390 ext. +90, zhrkzlk1906@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Low back pain group, Healthy group
- Keywords
- Rehabilitation, Kinematics, Activities of Daily Living
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low back pain groupOther
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
Healthy groupOther
Low back pain kinematics compare them with asymptomatic kontrols
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain Group | Experimental | 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, Receives: Other: Low back pain group |
| Healthy Group | Active comparator | Healthy Group's results will be compared them with low back pain group Receives: Other: Healthy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the kinematics of the all spine during walking
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.
Measured: two months
Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects
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.
Measured: two months
Evaluation of the kinematics of the all spine during Standing from Sitting
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.
Measured: two months
Evaluation of the kinematics of the all spine during Climbing Step
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
Measured: two months
Secondary outcomes (4)
Spine Normal Joint Movement evaluation
Lumbar Spine Normal Joint Movement of Flexion, Extension, Lateral Flexion and Rotation movements will be evaluated by goniometric measurement.
Measured: two months
Pain intensity: Visual Analog Scale
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).
Measured: two months
Oswestry Disability Index
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.
Measured: two months
Fear of movement: Tampa Kinesiophobia Scale
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Dec 2023
- Primary completion20 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Low back pain group and healthy group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyye Zehra Guler, Hacettepe University
- Investigators
- Sümeyye Zehra Güler, MSc, Principal investigator, +90 5079320390
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276322
- Sponsor's protocol ID
- HU-FTR-SZK-01
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell K, Porter M, Anderson L, Phillips C, Arceo G, Montz B, Levy S, Gombatto SP. Differences in lumbar spine and lower extremity kinematics in people with and without low back pain during a step-up task: a cross-sectional study. BMC Musculoskelet Disord. 2017 Aug 25;18(1):369. doi: 10.1186/s12891-017-1721-z.
PubMed 28841866Gombatto SP, Brock T, DeLork A, Jones G, Madden E, Rinere C. Lumbar spine kinematics during walking in people with and people without low back pain. Gait Posture. 2015 Oct;42(4):539-44. doi: 10.1016/j.gaitpost.2015.08.010. Epub 2015 Sep 3.
PubMed 26380913Papi E, Bull AMJ, McGregor AH. Spinal segments do not move together predictably during daily activities. Gait Posture. 2019 Jan;67:277-283. doi: 10.1016/j.gaitpost.2018.10.031. Epub 2018 Oct 29.
PubMed 30391750Laird RA, Keating JL, Ussing K, Li P, Kent P. Does movement matter in people with back pain? Investigating 'atypical' lumbo-pelvic kinematics in people with and without back pain using wireless movement sensors. BMC Musculoskelet Disord. 2019 Jan 18;20(1):28. doi: 10.1186/s12891-018-2387-x.
PubMed 30658610Saito H, Watanabe Y, Kutsuna T, Futohashi T, Kusumoto Y, Chiba H, Kubo M, Takasaki H. Spinal movement variability associated with low back pain: A scoping review. PLoS One. 2021 May 24;16(5):e0252141. doi: 10.1371/journal.pone.0252141. eCollection 2021.
PubMed 34029347Dogan M, Kocak M, Onursal Kilinc O, Ayvat F, Sutcu G, Ayvat E, Kilinc M, Unver O, Aksu Yildirim S. Functional range of motion in the upper extremity and trunk joints: Nine functional everyday tasks with inertial sensors. Gait Posture. 2019 May;70:141-147. doi: 10.1016/j.gaitpost.2019.02.024. Epub 2019 Feb 25.
PubMed 30875600Papi E, Bull AMJ, McGregor AH. Is there evidence to use kinematic/kinetic measures clinically in low back pain patients? A systematic review. Clin Biomech (Bristol). 2018 Jun;55:53-64. doi: 10.1016/j.clinbiomech.2018.04.006. Epub 2018 Apr 11.
PubMed 29684790Fong DT, Chan YY. The use of wearable inertial motion sensors in human lower limb biomechanics studies: a systematic review. Sensors (Basel). 2010;10(12):11556-65. doi: 10.3390/s101211556. Epub 2010 Dec 16.
PubMed 22163542Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.
PubMed 27262182Christe G, Aussems C, Jolles BM, Favre J. Patients With Chronic Low Back Pain Have an Individual Movement Signature: A Comparison of Angular Amplitude, Angular Velocity and Muscle Activity Across Multiple Functional Tasks. Front Bioeng Biotechnol. 2021 Nov 15;9:767974. doi: 10.3389/fbioe.2021.767974. eCollection 2021.
PubMed 34869281Christe G, Rochat V, Jolles BM, Favre J. Lumbar and thoracic kinematics during step-up: Comparison of three-dimensional angles between patients with chronic low back pain and asymptomatic individuals. J Orthop Res. 2020 Jun;38(6):1248-1256. doi: 10.1002/jor.24575. Epub 2020 Jan 7.
PubMed 31879969Aartun E, Axen I, Mior S, Roe Y, Hondras M, Kretz L, Cote P. Contextualizing the lived experiences of patients with low back pain from different countries according to the ICF framework. J Rehabil Med. 2021 May 11;53(5):jrm00189. doi: 10.2340/16501977-2819.
PubMed 33778896
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06276322
- Acronym / sponsor ID
- HU-FTR-SZK-01
- Conditions
- Low Back Pain
- Keywords
- Rehabilitation, Kinematics, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Feb 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Low back pain group and healthy group
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain Group | Experimental | Other: Low back pain groupLow 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, |
| Healthy Group | Active comparator | Other: Healthy groupHealthy Group's results will be compared them with low back pain group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Individuals aged 18-55 with no history of low back pain lasting more than 1 week for 6 months prior to the study
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Low back pain groupThe 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 | Other | Low Back Pain Group |
| Healthy groupLow back pain kinematics compare them with asymptomatic kontrols | Other | Healthy Group |
Primary outcome
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.
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.
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.
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
4 secondary outcomes
Spine Normal Joint Movement evaluation
Time frame: two months
Pain intensity: Visual Analog Scale
Time frame: two months
Oswestry Disability Index
Time frame: two months
Fear of movement: Tampa Kinesiophobia Scale
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 28841866Mitchell K, Porter M, Anderson L, Phillips C, Arceo G, Montz B, Levy S, Gombatto SP. Differences in lumbar spine and lower extremity kinematics in people with and without low back pain during a step-up task: a cross-sectional study. BMC Musculoskelet Disord. 2017 Aug 25;18(1):369. doi: 10.1186/s12891-017-1721-z.
- Background: PubMed 26380913Gombatto SP, Brock T, DeLork A, Jones G, Madden E, Rinere C. Lumbar spine kinematics during walking in people with and people without low back pain. Gait Posture. 2015 Oct;42(4):539-44. doi: 10.1016/j.gaitpost.2015.08.010. Epub 2015 Sep 3.
- Background: PubMed 30391750Papi E, Bull AMJ, McGregor AH. Spinal segments do not move together predictably during daily activities. Gait Posture. 2019 Jan;67:277-283. doi: 10.1016/j.gaitpost.2018.10.031. Epub 2018 Oct 29.
- Background: PubMed 30658610Laird RA, Keating JL, Ussing K, Li P, Kent P. Does movement matter in people with back pain? Investigating 'atypical' lumbo-pelvic kinematics in people with and without back pain using wireless movement sensors. BMC Musculoskelet Disord. 2019 Jan 18;20(1):28. doi: 10.1186/s12891-018-2387-x.
- Background: PubMed 34029347Saito H, Watanabe Y, Kutsuna T, Futohashi T, Kusumoto Y, Chiba H, Kubo M, Takasaki H. Spinal movement variability associated with low back pain: A scoping review. PLoS One. 2021 May 24;16(5):e0252141. doi: 10.1371/journal.pone.0252141. eCollection 2021.
- Background: PubMed 30875600Dogan M, Kocak M, Onursal Kilinc O, Ayvat F, Sutcu G, Ayvat E, Kilinc M, Unver O, Aksu Yildirim S. Functional range of motion in the upper extremity and trunk joints: Nine functional everyday tasks with inertial sensors. Gait Posture. 2019 May;70:141-147. doi: 10.1016/j.gaitpost.2019.02.024. Epub 2019 Feb 25.
- Background: PubMed 29684790Papi E, Bull AMJ, McGregor AH. Is there evidence to use kinematic/kinetic measures clinically in low back pain patients? A systematic review. Clin Biomech (Bristol). 2018 Jun;55:53-64. doi: 10.1016/j.clinbiomech.2018.04.006. Epub 2018 Apr 11.
- Background: PubMed 22163542Fong DT, Chan YY. The use of wearable inertial motion sensors in human lower limb biomechanics studies: a systematic review. Sensors (Basel). 2010;10(12):11556-65. doi: 10.3390/s101211556. Epub 2010 Dec 16.
- Background: PubMed 27262182Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.
- Background: PubMed 34869281Christe G, Aussems C, Jolles BM, Favre J. Patients With Chronic Low Back Pain Have an Individual Movement Signature: A Comparison of Angular Amplitude, Angular Velocity and Muscle Activity Across Multiple Functional Tasks. Front Bioeng Biotechnol. 2021 Nov 15;9:767974. doi: 10.3389/fbioe.2021.767974. eCollection 2021.
- Background: PubMed 31879969Christe G, Rochat V, Jolles BM, Favre J. Lumbar and thoracic kinematics during step-up: Comparison of three-dimensional angles between patients with chronic low back pain and asymptomatic individuals. J Orthop Res. 2020 Jun;38(6):1248-1256. doi: 10.1002/jor.24575. Epub 2020 Jan 7.
- Background: PubMed 33778896Aartun E, Axen I, Mior S, Roe Y, Hondras M, Kretz L, Cote P. Contextualizing the lived experiences of patients with low back pain from different countries according to the ICF framework. J Rehabil Med. 2021 May 11;53(5):jrm00189. doi: 10.2340/16501977-2819.
- 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.
Sümeyye Zehra Güler, MSc principal investigator
+90 5079320390
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low back pain group and Healthy group in people with Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sümeyye Zehra Güler, MSc (5079320390 ext. +90, zhrkzlk1906@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the kinematics of the all spine during walking (time frame: two months). The study lists 4 primary outcomes in all. 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 NCT06276322, which also lists 12 linked publications.
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 7 Mar 2024.