Low Back PainNCT06686147
AI-Assisted Analysis of Range of Motion in Patients With Low Back Pain
An observational study of Low Back Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain (LBP) is a common musculoskeletal problem that is frequently encountered in the population and can occur at any age. Responsible for the loss of a full healthy year in both the 10-24 and 50-74 age groups, LBP causes significant personal and social losses and increases healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Assessment of Joint Range of Motion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 1 May 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Chronic low back pain patient
Who may be able to join
- Ages 18-65
- Individuals who have experienced lower back pain for at least 3 months
- Individuals who have consulted a doctor at least once due to lower back pain
- Individuals who agree to participate in the study and have signed the informed consent form
Who cannot join
- Individuals who have undergone surgical intervention due to lower back pain
- Individuals with acute traumatic injuries
- Individuals with neurological or systemic diseases unrelated to the musculoskeletal system
- Individuals who have received physiotherapy or surgical treatment for lower back pain in the last three months
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
Seref Duhan Altug, 05343848233, altugsd@gmail.com
About this study
Official title: Comparison of Range of Motion in Patients With Low Back Pain Using Artificial Intelligence-Assisted Analysis Method
Low back pain (LBP) is a common musculoskeletal problem that is frequently encountered in the population and can occur at any age. Responsible for the loss of a full healthy year in both the 10-24 and 50-74 age groups, LBP causes significant personal and social losses and increases healthcare costs.
In the classification of low back pain, pain that persists for up to 6 weeks is defined as acute, pain that lasts between 6-12 weeks is subacute, and pain that persists for more than 12 weeks is considered chronic low back pain (CLBP).
Read more
Chronic LBP (CLBP) leads to fear of movement, causing patients to limit their daily activities and social participation to avoid pain. A sedentary lifestyle in LBP patients is a factor that contributes to the chronicity of the disease. While most acute LBP patients recover well within a few weeks or months, the prognosis for patients with chronic low back pain is generally poor. Approximately one-quarter of patients visiting primary care facilities develop chronic LBP.
Therefore, identifying the risk factors for chronic LBP, understanding the population at risk of developing chronic LBP, identifying high-risk individuals, and implementing appropriate preventive and therapeutic measures are important.
Several musculoskeletal problems have played a role as risk factors in the development of LBP, and identifying and validating these risk factors can provide a potential mechanism through which LBP can be effectively treated. Accurately identifying musculoskeletal problems and risk factors can provide a mechanism to prevent the development of LBP and reduce the socioeconomic burden associated with the condition.
Machine learning (ML) is a scientific discipline that uses computer algorithms to identify patterns in large amounts of data and make predictions on new datasets based on these patterns. ML creates models to predict unknown data from historical data and allows us to select the most appropriate algorithm. Additionally, ML algorithms can extract variables that contribute to the prediction of the target variable, and differ from traditional statistical methods in enhancing the accuracy of future data predictions. ML has shown excellent performance in increasing the predictive value of medical imaging and postoperative clinical outcomes.
The aim of this study is to compare the joint range of motion in patients with low back pain and healthy individuals, and to detect differences in these ranges using artificial intelligence-supported analysis methods.
- Conditions
- Low Back Pain
- Being tested
- Assessment of Joint Range of Motion
- 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.
Assessment of Joint Range of MotionDiagnostic test
Joint range of motion (ROM) measurements will be conducted to assess the specific ranges of motion of participants' joints.
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain Patient Group | Not described Receives: Diagnostic Test: Assessment of Joint Range of Motion | |
| Healthy Control Group | Not described Receives: Diagnostic Test: Assessment of Joint Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Evaluation
This outcome measure assesses changes in pain levels using the Visual Analog Scale (VAS), a validated tool for pain evaluation. Pain intensity will be recorded by having participants rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). Pain assessments will be conducted at baseline and follow-up intervals to track changes in reported pain intensity over time. The VAS provides a quantitative measurement of pain that is sensitive to minor changes, allowing for accurate monitoring of treatment effectiveness or condition progression.
Measured: 5 minute
Joint Range of Motion (ROM)
The primary outcome for this clinical study is the evaluation of Joint Range of Motion (ROM) in degrees (°), measured using the Halo digital goniometer. The assessment will include both active and passive ROM for major joints: shoulder, elbow, wrist, neck, lumbar spine, hip, knee, and ankle. Each joint's ROM will be recorded in degrees to provide a quantitative measure of flexibility and mobility. Data will be analyzed against normative values to determine any deviation or restriction in movement.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start20 Dec 2024
- Primary completion16 Dec 2025 (estimated)
- Study completion1 May 2026 (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 Pamukkale 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seref Duhan Altug, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686147
- Sponsor's protocol ID
- Sltug
- Status last verified
- Mar 2025
- First submitted
- 5 Nov 2024
- Last updated
- 4 Mar 2025
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Range of Motion in Patients With Low Back Pain Using Artificial Intelligence-Assisted Analysis Method
- ClinicalTrials.gov ID
- NCT06686147
- Acronym / sponsor ID
- Sltug
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 13 Nov 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.
Low back pain (LBP) is a common musculoskeletal problem that is frequently encountered in the population and can occur at any age. Responsible for the loss of a full healthy year in both the 10-24 and 50-74 age groups, LBP causes significant personal and social losses and increases healthcare costs.
In the classification of low back pain, pain that persists for up to 6 weeks is defined as acute, pain that lasts between 6-12 weeks is subacute, and pain that persists for more than 12 weeks is considered chronic low back pain (CLBP).
Chronic LBP (CLBP) leads to fear of movement, causing patients to limit their daily activities and social participation to avoid pain. A sedentary lifestyle in LBP patients is a factor that contributes to the chronicity of the disease. While most acute LBP patients recover well within a few weeks or months, the prognosis for patients with chronic low back pain is generally poor. Approximately one-quarter of patients visiting primary care facilities develop chronic LBP.
Therefore, identifying the risk factors for chronic LBP, understanding the population at risk of developing chronic LBP, identifying high-risk individuals, and implementing appropriate preventive and therapeutic measures are important.
Several musculoskeletal problems have played a role as risk factors in the development of LBP, and identifying and validating these risk factors can provide a potential mechanism through which LBP can be effectively treated. Accurately identifying musculoskeletal problems and risk factors can provide a mechanism to prevent the development of LBP and reduce the socioeconomic burden associated with the condition.
Machine learning (ML) is a scientific discipline that uses computer algorithms to identify patterns in large amounts of data and make predictions on new datasets based on these patterns. ML creates models to predict unknown data from historical data and allows us to select the most appropriate algorithm. Additionally, ML algorithms can extract variables that contribute to the prediction of the target variable, and differ from traditional statistical methods in enhancing the accuracy of future data predictions. ML has shown excellent performance in increasing the predictive value of medical imaging and postoperative clinical outcomes.
The aim of this study is to compare the joint range of motion in patients with low back pain and healthy individuals, and to detect differences in these ranges using artificial intelligence-supported analysis methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain Patient Group | – | Diagnostic Test: Assessment of Joint Range of Motion |
| Healthy Control Group | – | Diagnostic Test: Assessment of Joint Range of Motion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic low back pain patient
Key inclusion criteria (4 listed)
- Ages 18-65
- Individuals who have experienced lower back pain for at least 3 months
- Individuals who have consulted a doctor at least once due to lower back pain
- Individuals who agree to participate in the study and have signed the informed consent form
Key exclusion criteria (5 listed)
- Individuals who have undergone surgical intervention due to lower back pain
- Individuals with acute traumatic injuries
- Individuals with neurological or systemic diseases unrelated to the musculoskeletal system
- Individuals who have received physiotherapy or surgical treatment for lower back pain in the last three months
- Pregnancy
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 |
|---|---|---|
| Assessment of Joint Range of MotionJoint range of motion (ROM) measurements will be conducted to assess the specific ranges of motion of participants' joints. | Diagnostic test | Healthy Control Group, Low Back Pain Patient Group |
Primary outcome
Pain Evaluation
Time frame: 5 minute
This outcome measure assesses changes in pain levels using the Visual Analog Scale (VAS), a validated tool for pain evaluation. Pain intensity will be recorded by having participants rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). Pain assessments will be conducted at baseline and follow-up intervals to track changes in reported pain intensity over time. The VAS provides a quantitative measurement of pain that is sensitive to minor changes, allowing for accurate monitoring of treatment effectiveness or condition progression.
Joint Range of Motion (ROM)
Time frame: 20 minutes
The primary outcome for this clinical study is the evaluation of Joint Range of Motion (ROM) in degrees (°), measured using the Halo digital goniometer. The assessment will include both active and passive ROM for major joints: shoulder, elbow, wrist, neck, lumbar spine, hip, knee, and ankle. Each joint's ROM will be recorded in degrees to provide a quantitative measure of flexibility and mobility. Data will be analyzed against normative values to determine any deviation or restriction in movement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Pamukkale 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 4 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seref Duhan Altug (05343848233, altugsd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Evaluation (time frame: 5 minute). The study lists 2 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 4 Mar 2025.