Low Back PainNCT05503121
Relationship Between Biomarkers and Biomechanical in Nonspecific Low Back Pain
An observational study of Low Back Pain, run by Istinye University.
Trial summary
Nonspecific low back pain is one of the most common health problems today. Although it is encountered so frequently, the relationships between the symptoms of patients who complain of low back pain have not been fully explained. With pain, changes occur in the body of individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- 3D motion analysis, muscle activation, biomarker analysis
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Feb 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals between the ages of 18-45 who have had nonspecific low back pain.
Who may be able to join
- Nonspecific low back pain diagnosed by a physical therapy and rehabilitation specialist,
- For participants with pain, those who defined their pain on a scale of 3-7 on VAS,
- Individuals between the ages of 18-45 who have had pain in the lumbar region for at least 3 months,
- Those who do not have an infectious condition for any other reason (gum infection, metabolic diseases, viral infections, etc.) will be included in the study.
Who cannot join
- Diagnosed with disc herniation,
- diagnosed with scoliosis,
- Lumbal spine surgery or lumbar spine trauma,
- Those with a history of spine infection, tumor, osteoporosis, structural deformity, cauda equina syndrome, radicular syndrome,
- Those who participated in the period 1 week before and 1 week after the menstrual cycle,
- Diagnosed with rheumatic disease,
- Individuals with difficulty in cooperation and
- Individuals who received physical therapy within 3 months will not be included in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Relationship Between Biomarkers and Biomechanical Properties in Individuals With Nonspecific Low Back Pain
Nonspecific low back pain is one of the most common health problems today. Although it is encountered so frequently, the relationships between the symptoms of patients who complain of low back pain have not been fully explained.
With pain, changes occur in the body of individuals. When the blood values of individuals are examined, changes are observed in their biomarkers. Two of these biomarkers are anti-inflammatory and pro-inflammatory biomarkers. These two biomarkers indicate that there is an inflammation in the body. Inflammation can cause pain. Pain also prevents individuals from performing their movements correctly and can cause individuals to make biomechanical changes in their bodies that will make them feel less pain. Clinicians and physiotherapists treat symptoms for pain, patients' pain starts again or does not go away at all because the underlying problem is not fully understood and resolved.
Read more
Biomechanical features that can be explained as muscle activation and joint movements can be defined as the lowest unit of functional movement. These movements combine to form functions. When we search for functionality in the literature, we see that the functionality increases with the decrease of inflammation. Functions performed in a different way than normal due to pain and changes in these functions may or may not be at an observable level. For this reason, the biomechanical changes of individuals with pain will be analyzed with a more detailed and objective measurement system.
The three-dimensional motion analysis system and muscle activation measuring devices to be used in this study are devices that can make the most accurate and precise measurement and allow us to examine the lowest unit of motion. This study will go to the basis of the movement and understand the problems there and will contribute to the production of permanent solutions in future studies.
Pain and biomarkers and pain and biomechanical properties were evaluated separately in the studies, no study was found that examined biomechanical properties and biomarkers together. The aim of the project is to examine the relationship between inflammation and biomechanical properties. At the end of the project, the relationship between inflammation and biomechanical changes in low back pain will be demonstrated objectively, and it is anticipated that new treatment strategies can be developed for nonspecific low back pain.
- Conditions
- Low Back Pain
- Being tested
- 3D motion analysis, muscle activation, biomarker analysis
- Keywords
- Biomarker, Biomechanic, Nonspecific low back pain, 3D motion analysis system, sEMG
- 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.
3D motion analysis, muscle activation, biomarker analysisDiagnostic test
Participants with nonspesific low back pain and control group will be analysed with 3D motion analysis sistem, sEMG and will be checked the biomarkers. Then the data will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The volunteer group planned to be included in the study will consist of individuals diagnosed with Nonspecific Low Back Pain who applied to Istinye University Physiotherapy and Rehabilitation Application and Research Center (Isu Fizyotem).
21 volunteers with low back pain will be included in the study. Receives: Diagnostic Test: 3D motion analysis, muscle activation, biomarker analysis | |
| Contol Group | The control group will consist of healthy individuals. 21 healty volunteers will be included in the study. Receives: Diagnostic Test: 3D motion analysis, muscle activation, biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion analysis
Noraxon MyoMotion 3D motion analysis system will be used. Inertial measurement unit (IMU) are placed on any body segment with elastic fixation straps.
The sensors will be placed in the spinal processes of Thoracic 12, Lumbar 3 and Sacral 2 with adjustable straps. The participant is asked to stand while placing the sensors. T12 level is found by palpating the spinal processes of the spines. Sacral 2 spinal process is palpated from line between right and left posterior superior spina iliaca. efore each measurement, the IMU sensors will be calibrated for body position. Data collected with a sampling frequency of 200 Hz will be recorded. A laptop camera will be used as a camera during the measurements.
Measured: baseline
Muscle activation
Noraxon MyoMuscle system will be used. The MyoMuscle system processes the signals sent by superficial electromyography (sEMG) electrodes placed on the participants' body. The electrodes used in sEMG measurement are Ag/AgC superficial electrodes. In the EMG analysis, 2 muscle groups will be evaluated, and the electrodes will be placed bilaterally.
Lumbal erector spines: Electrodes is placed 3 cm lateral to the spinal process of the fourth lumbar spine.
Obliquus internus: The electrode is placed 2 cm medial to the anterior superior iliac spine.
The signals of muscle movements of the electrode-placed muscles during standing up from sitting will be measured.
TeleMyo DTS will be used to collect EMG data. Collected data will be filtered by MyoResearch XP 1.72 software.
Measured: baseline
Short Form McGill Pain Questionnaire
The McGill Pain Questionnaire consists of a total of 15 descriptive words. Of the 15 words used to evaluate the dimensions of pain, 11 are used to evaluate the sensory and 4 are used to evaluate the affective dimensions of pain. Pain intensity is scored by the patient as 0=absent, 1=mild, 2=moderate, 3=severe. Total scores are scored at three levels: sensory, affective, and total (sensory+affective). The Short Form McGill questionnaire has a visual analog scale used to assess the severity of pain and a 6-point Likert scale. In the Likert scale of SF- McGill index, 0 = no pain, 1 = mild, 2 = bothersome, 3 = distressing, 4 = awful, 5 = excruciating pain.
Measured: baseline
Analysis of Inflammatory Markers (Interleukin-1Beta, Tumor Necrosis Factor Alpha, Interleukin-6, Interleukin-2, Interleukin-8, Interleukin-10 )
Changes between individuals with low back pain and healthy individuals.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion20 Nov 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503121
- Sponsor's protocol ID
- 3/2022.K-65
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Biomarkers and Biomechanical Properties in Individuals With Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT05503121
- Acronym / sponsor ID
- 3/2022.K-65
- Conditions
- Low Back Pain
- Keywords
- Biomarker, Biomechanic, Nonspecific low back pain, 3D motion analysis system, sEMG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 16 Aug 2022 (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.
Nonspecific low back pain is one of the most common health problems today. Although it is encountered so frequently, the relationships between the symptoms of patients who complain of low back pain have not been fully explained.
With pain, changes occur in the body of individuals. When the blood values of individuals are examined, changes are observed in their biomarkers. Two of these biomarkers are anti-inflammatory and pro-inflammatory biomarkers. These two biomarkers indicate that there is an inflammation in the body. Inflammation can cause pain. Pain also prevents individuals from performing their movements correctly and can cause individuals to make biomechanical changes in their bodies that will make them feel less pain. Clinicians and physiotherapists treat symptoms for pain, patients' pain starts again or does not go away at all because the underlying problem is not fully understood and resolved.
Biomechanical features that can be explained as muscle activation and joint movements can be defined as the lowest unit of functional movement. These movements combine to form functions. When we search for functionality in the literature, we see that the functionality increases with the decrease of inflammation. Functions performed in a different way than normal due to pain and changes in these functions may or may not be at an observable level. For this reason, the biomechanical changes of individuals with pain will be analyzed with a more detailed and objective measurement system.
The three-dimensional motion analysis system and muscle activation measuring devices to be used in this study are devices that can make the most accurate and precise measurement and allow us to examine the lowest unit of motion. This study will go to the basis of the movement and understand the problems there and will contribute to the production of permanent solutions in future studies.
Pain and biomarkers and pain and biomechanical properties were evaluated separately in the studies, no study was found that examined biomechanical properties and biomarkers together. The aim of the project is to examine the relationship between inflammation and biomechanical properties. At the end of the project, the relationship between inflammation and biomechanical changes in low back pain will be demonstrated objectively, and it is anticipated that new treatment strategies can be developed for nonspecific low back pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: 3D motion analysis, muscle activation, biomarker analysisThe volunteer group planned to be included in the study will consist of individuals diagnosed with Nonspecific Low Back Pain who applied to Istinye University Physiotherapy and Rehabilitation Application and Research Center (Isu Fizyotem). 21 volunteers with low back pain will be included in the study. |
| Contol Group | – | Diagnostic Test: 3D motion analysis, muscle activation, biomarker analysisThe control group will consist of healthy individuals. 21 healty volunteers will be included in the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals between the ages of 18-45 who have had nonspecific low back pain.
Key inclusion criteria (4 listed)
- Nonspecific low back pain diagnosed by a physical therapy and rehabilitation specialist,
- For participants with pain, those who defined their pain on a scale of 3-7 on VAS,
- Individuals between the ages of 18-45 who have had pain in the lumbar region for at least 3 months,
- Those who do not have an infectious condition for any other reason (gum infection, metabolic diseases, viral infections, etc.) will be included in the study.
Key exclusion criteria (8 listed)
- Diagnosed with disc herniation,
- diagnosed with scoliosis,
- Lumbal spine surgery or lumbar spine trauma,
- Those with a history of spine infection, tumor, osteoporosis, structural deformity, cauda equina syndrome, radicular syndrome,
- Those who participated in the period 1 week before and 1 week after the menstrual cycle,
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 |
|---|---|---|
| 3D motion analysis, muscle activation, biomarker analysisParticipants with nonspesific low back pain and control group will be analysed with 3D motion analysis sistem, sEMG and will be checked the biomarkers. Then the data will be compared. | Diagnostic test | Contol Group, Study Group |
Primary outcome
Motion analysis
Time frame: baseline
Noraxon MyoMotion 3D motion analysis system will be used. Inertial measurement unit (IMU) are placed on any body segment with elastic fixation straps. The sensors will be placed in the spinal processes of Thoracic 12, Lumbar 3 and Sacral 2 with adjustable straps. The participant is asked to stand while placing the sensors. T12 level is found by palpating the spinal processes of the spines. Sacral 2 spinal process is palpated from line between right and left posterior superior spina iliaca. efore each measurement, the IMU sensors will be calibrated for body position. Data collected with a sampling frequency of 200 Hz will be recorded. A laptop camera will be used as a camera during the measurements.
Muscle activation
Time frame: baseline
Noraxon MyoMuscle system will be used. The MyoMuscle system processes the signals sent by superficial electromyography (sEMG) electrodes placed on the participants' body. The electrodes used in sEMG measurement are Ag/AgC superficial electrodes. In the EMG analysis, 2 muscle groups will be evaluated, and the electrodes will be placed bilaterally. Lumbal erector spines: Electrodes is placed 3 cm lateral to the spinal process of the fourth lumbar spine. Obliquus internus: The electrode is placed 2 cm medial to the anterior superior iliac spine. The signals of muscle movements of the electrode-placed muscles during standing up from sitting will be measured. TeleMyo DTS will be used to collect EMG data. Collected data will be filtered by MyoResearch XP 1.72 software.
Short Form McGill Pain Questionnaire
Time frame: baseline
The McGill Pain Questionnaire consists of a total of 15 descriptive words. Of the 15 words used to evaluate the dimensions of pain, 11 are used to evaluate the sensory and 4 are used to evaluate the affective dimensions of pain. Pain intensity is scored by the patient as 0=absent, 1=mild, 2=moderate, 3=severe. Total scores are scored at three levels: sensory, affective, and total (sensory+affective). The Short Form McGill questionnaire has a visual analog scale used to assess the severity of pain and a 6-point Likert scale. In the Likert scale of SF- McGill index, 0 = no pain, 1 = mild, 2 = bothersome, 3 = distressing, 4 = awful, 5 = excruciating pain.
Analysis of Inflammatory Markers (Interleukin-1Beta, Tumor Necrosis Factor Alpha, Interleukin-6, Interleukin-2, Interleukin-8, Interleukin-10 )
Time frame: baseline
Changes between individuals with low back pain and healthy individuals.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Istinye 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 4 inclusion and 8 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 16 Aug 2022. 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 Yasemin Buran Cirak, Prof. Dr. (+905443759723, ycirak@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion analysis (time frame: baseline). 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?
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 16 Aug 2022.