Low Back Pain, MechanicalNCT07039214
Thoracolumbar Fascia Flexibility and Trunk Proprioception Relationship With Spinal Posture
An observational study of Low Back Pain, Mechanical, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the associations between thoracolumbar fascia flexibility, trunk proprioception, and spinal posture in individuals experiencing non-specific low back pain. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Observation of low-back pain symptoms and Observation of healthy comparators
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2022to 15 Apr 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 35 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with non-specific low back pain and healthy participants of same age were included in this study.
Who may be able to join
- Willingness to voluntarily participate in the study
- Age range between 35 and 65 years
- Reporting a pain intensity in the lumbar region greater than 3 on the Visual Analog Scale (VAS)
- Experiencing lumbar region pain for a duration of at least three months
- Reporting pain intensity below 3 on the VAS in any other part of the body
Who cannot join
- History of surgical intervention in the lumbar region
- Being diagnosed with conditions such as osteoporosis, rheumatic diseases infection, fracture, structural deformity, cauda equina syndrome, tumor, radicular syndrome, or inflammatory disorders
- Classification as "very active" based on the International Physical Activity Questionnaire (IPAQ) criteria
- Hypermobility, defined as a Beighton Score of 4 or higher
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: The Relationship of Thoracolumbar Fascia Flexibility With Trunk Proprioception and Spinal Posture in Individuals With Non-specific Low Back Pain
This study aimed to examine the associations between thoracolumbar fascia flexibility, trunk proprioception, and spinal posture in individuals experiencing non-specific low back pain.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Observation of low-back pain symptoms, Observation of healthy comparators
- Keywords
- Proprioception, Fascia
- 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.
Observation of low-back pain symptomsOther
No intervention was applied.
Observation of healthy comparatorsOther
No intervention was applied.
| Study group | Role | What they receive |
|---|---|---|
| Non-Specific low back pain group | Patients with non-Specific low back pain was included in this group. Receives: Other: Observation of low-back pain symptoms | |
| Asymptomatic group | Healthy people with no low back pain or any other symptom related to this region. Receives: Other: Observation of healthy comparators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracolumbar fascia flexibility
The goniometric platform will be placed on a table in front of the participants to measure thoracolumbar flexibility (TLF). Participants will be seated on an unsupported chair with the lumbar region in a neutral position and the knees and hips flexed at 90°. The pelvis will be stabilized by the researcher holding the spina iliaca posterior superior. Participants will be instructed to rotate their trunk first to the right and then to the left, following verbal cues provided by the researcher. At the endpoint of each rotation, participants will be asked to mark the platform in front of them while maintaining 90° shoulder flexion, with their hands clasped in front of the trunk and holding a wooden pen between their hands. Each measurement will be performed three times for each side, and the average value will be recorded.
Measured: baseline
Secondary outcomes (5)
Proprioception Measurement
The "Clinometer" mobile application will be used to assess proprioception. Participants will stand upright with their arms at their sides, heels spaced 3 cm apart, and their gaze fixed on a point at eye level. The phone will be placed in an upright position just above the iliac crest, aligned with the mid-axillary line at the midpoint of the iliac spine, and secured with a belt. The inclination of the clinometer will be calibrated to 0°, which will serve as the starting point. The range of motion will be limited to 0-30°.
The physiotherapist will first passively move the participant's trunk to the target angle, where the participant will remain for 10 seconds to memorize the position. Afterward, the participant will actively return to the starting position. Then, the participant will be instructed to actively replicate the target angle three times with their eyes closed. The mean deviation across the three attempts will be recorded as the proprioception value.
Measured: baseline
Spinal Posture Assessment
The Spinal Mouse (Idiag, Voletswil, Switzerland, SM) device will be employed to assess spinal posture. Prior to the measurement, the researcher will demonstrate all required positions to the participants. Participants will be instructed to hold each position for 1-2 seconds. They will be asked to remove their clothing to expose all spinous processes, which will be palpated and marked from C7 to S3 using a felt-tip pen by the researcher. The Spinal Mouse will then be guided along the marked points from top to bottom.
Participants will be evaluated in three positions: upright, maximum trunk flexion, and maximum trunk extension.
Measured: baseline
Visual Analog Scale
Pain intensity will be assessed using a 0-10 cm horizontal Visual Analog Scale (VAS). On this scale, a 10 cm line will be anchored with "0: no pain" at one end and "10: unbearable pain" at the other. Participants will be instructed to indicate the intensity of their pain by placing a dot, drawing a line, or marking a specific point along the scale. The distance from the starting point to the participant's mark will represent their perceived pain intensity. Pain levels will be classified as follows: 0-3.4 cm will indicate mild pain, 3.5-7.4 cm moderate pain, and 7.5 cm or more severe pain.
Measured: baseline
Oswestry Low Back Pain Disability Questionnaire
The Oswestry Disability Questionnaire will be widely utilized to assess specific outcomes in individuals with spinal problems. It will consist of 10 items that evaluate various functional aspects, each scored on a scale from 0 to 5. The total score will be calculated by summing the individual item scores, multiplying the result by 2, and expressing it as a percentage. Higher percentages will indicate greater levels of disability.
Scoring classifications will be as follows:
0-20%: Low back pain will not significantly impact the individual's daily life.
20-40%: Low back pain will mildly restrict the individual's daily activities.
40-60%: Low back pain will severely restrict the individual's daily activities.
60-80%: The individual's daily life will be significantly impaired due to low back pain.
80-100%: The individual will be considered bedridden (symptoms may be exaggerated).
Measured: baseline
International Physical Activity Questionnaire - Short Form
This questionnaire will be a standardized tool developed by researchers from multiple countries, supported by the World Health Organization, to assess levels of physical activity. The original version will consist of 27 items, while the short form will include 7 items. Participants will be asked to estimate the duration and frequency of their physical activity over the previous week. The reported durations will be multiplied by known metabolic equivalents values for each activity, and an overall score will be calculated by summing the results for all items. Scores for walking, moderate activity, and vigorous activity will be determined by summing the corresponding item scores. Time spent sitting will be excluded from the calculation.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start6 Sep 2022
- Primary completion1 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- ramazan kurul, Ph.D, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039214
- Sponsor's protocol ID
- AIBU-FTR-RK-10
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 29 Jun 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Thoracolumbar Fascia Flexibility With Trunk Proprioception and Spinal Posture in Individuals With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07039214
- Acronym / sponsor ID
- AIBU-FTR-RK-10
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Proprioception, Fascia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 26 Jun 2025 (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.
This study aimed to examine the associations between thoracolumbar fascia flexibility, trunk proprioception, and spinal posture in individuals experiencing non-specific low back pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Specific low back pain group | – | Other: Observation of low-back pain symptomsPatients with non-Specific low back pain was included in this group. |
| Asymptomatic group | – | Other: Observation of healthy comparatorsHealthy people with no low back pain or any other symptom related to this region. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-specific low back pain and healthy participants of same age were included in this study.
Key inclusion criteria (5 listed)
- Willingness to voluntarily participate in the study
- Age range between 35 and 65 years
- Reporting a pain intensity in the lumbar region greater than 3 on the Visual Analog Scale (VAS)
- Experiencing lumbar region pain for a duration of at least three months
- Reporting pain intensity below 3 on the VAS in any other part of the body
Key exclusion criteria (5 listed)
- History of surgical intervention in the lumbar region
- Being diagnosed with conditions such as osteoporosis, rheumatic diseases infection, fracture, structural deformity, cauda equina syndrome, tumor, radicular syndrome, or inflammatory disorders
- Classification as "very active" based on the International Physical Activity Questionnaire (IPAQ) criteria
- Hypermobility, defined as a Beighton Score of 4 or higher
- 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 |
|---|---|---|
| Observation of low-back pain symptomsNo intervention was applied. | Other | Non-Specific low back pain group |
| Observation of healthy comparatorsNo intervention was applied. | Other | Asymptomatic group |
Primary outcome
Thoracolumbar fascia flexibility
Time frame: baseline
The goniometric platform will be placed on a table in front of the participants to measure thoracolumbar flexibility (TLF). Participants will be seated on an unsupported chair with the lumbar region in a neutral position and the knees and hips flexed at 90°. The pelvis will be stabilized by the researcher holding the spina iliaca posterior superior. Participants will be instructed to rotate their trunk first to the right and then to the left, following verbal cues provided by the researcher. At the endpoint of each rotation, participants will be asked to mark the platform in front of them while maintaining 90° shoulder flexion, with their hands clasped in front of the trunk and holding a wooden pen between their hands. Each measurement will be performed three times for each side, and the average value will be recorded.
5 secondary outcomes
Proprioception Measurement
Time frame: baseline
Spinal Posture Assessment
Time frame: baseline
Visual Analog Scale
Time frame: baseline
Oswestry Low Back Pain Disability Questionnaire
Time frame: baseline
International Physical Activity Questionnaire - Short Form
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain, Mechanical
Not yet recruiting
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
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
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.
ramazan kurul, Ph.D principal investigator
Abant Izzet Baysal University
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, Mechanical, run by Abant Izzet Baysal 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 5 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: finished, as of the sponsor's last update on 29 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracolumbar fascia flexibility (time frame: baseline). 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 29 Jun 2025.