PainNCT06537219
Changes in Thoracolumbar Fascia Stiffness and Pain Parameters in Young Patients With Chronic Low Back Pain
An observational study of Pain and Back Pain, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Sep 2024
- How long will I take part?
- 4 Weeks
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Academic staff and university students at Atılım University will constitude the study population. Sample size is calculated with 85% power. 50 participants( 25 experiment,25 control group) will be included in the study
Who may be able to join
- chronic back pain participants more than 3 months
Who cannot join
- Those with orthopaedic, neurological and systemic diseases will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atılım University
Ankara, 06830
Naime Uluğ, Ph.D, 05365434409, ulugnaime@gmail.com
About this study
Official title: Thoracolumbar Fascia Stiffness and Pain Parameters
This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.
Read the detailed description
Non-specific low back pain has become a serious public health problem in latest years. The prevalence of low back pain is reported to be 84% in lifetime (1). Recently, an increasing number of studies have reported that fascia, due to its rich nociceptive innervations, may play a role in chronic pain, especially in some non-specific low back pain conditions .
This study will conducted with a total of 50 participant, including those with chronic lower back pain in the experimental group and the control group.
Both groups underwent assessments related to pain properties. Specifically, the Numerical Pain Scale(NMS) will be used to assess subjective pain intensity(4), the Digital Algometer for assessing pressure pain treshold(5), the Pain Sensitivity Scale(PSS) pain sensitivity(6) and the Myotonometer MyotonPRO biomechanical parameters, including stiffness(s), elasticity(d) and tonus (f) of the TFL at the level of Lumbal 1,3 vertebrae(L1,L3) and under 12th costa (7-10). SPSS 23.0 will be used for statistical analysis. p<0.05 is considered statistically significant.
- Being tested
- Assessment
- Keywords
- non-spesific back pain, thoracolumbar fascia, stiffness, pain thresold
- Medical subject headings
- Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Assessment of pain severity,pain thresold of the fascia, pain sensitivity
| Study group | Role | What they receive |
|---|---|---|
| back pain group | participants with chronic back pain( pain duration at least 3 months) aged between 18 and 50 years , male and female participanst will be included in the study. Those with orthopaedic, neurological and systemic diseases will be excluded from the study. Receives: Other: Assessment | |
| control group | healty male and female participants aged between 18 and 50 years Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale(NMS
pain assessment
Measured: 1 month
Fascia stiffness
thoracolumbar fascia stiffness assessment
Measured: 1month
the Pain Sensitivity Scale(PSS)
Pain sensitivity assessment
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Jul 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAİME ULUG, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537219
- Sponsor's protocol ID
- E-59394181-604.01-79246
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracolumbar Fascia Stiffness and Pain Parameters
- ClinicalTrials.gov ID
- NCT06537219
- Acronym / sponsor ID
- E-59394181-604.01-79246
- Keywords
- non-spesific back pain, thoracolumbar fascia, stiffness, pain thresold
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 5 Aug 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.
This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.
Detailed description
Non-specific low back pain has become a serious public health problem in latest years. The prevalence of low back pain is reported to be 84% in lifetime (1). Recently, an increasing number of studies have reported that fascia, due to its rich nociceptive innervations, may play a role in chronic pain, especially in some non-specific low back pain conditions .
This study will conducted with a total of 50 participant, including those with chronic lower back pain in the experimental group and the control group.
Both groups underwent assessments related to pain properties. Specifically, the Numerical Pain Scale(NMS) will be used to assess subjective pain intensity(4), the Digital Algometer for assessing pressure pain treshold(5), the Pain Sensitivity Scale(PSS) pain sensitivity(6) and the Myotonometer MyotonPRO biomechanical parameters, including stiffness(s), elasticity(d) and tonus (f) of the TFL at the level of Lumbal 1,3 vertebrae(L1,L3) and under 12th costa (7-10). SPSS 23.0 will be used for statistical analysis. p<0.05 is considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| back pain group | – | Other: Assessmentparticipants with chronic back pain( pain duration at least 3 months) aged between 18 and 50 years , male and female participanst will be included in the study. Those with orthopaedic, neurological and systemic diseases will be excluded from the study. |
| control group | – | Other: Assessmenthealty male and female participants aged between 18 and 50 years |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Academic staff and university students at Atılım University will constitude the study population. Sample size is calculated with 85% power. 50 participants( 25 experiment,25 control group) will be included in the study
Key inclusion criteria (1 listed)
- chronic back pain participants more than 3 months
Key exclusion criteria (1 listed)
- Those with orthopaedic, neurological and systemic diseases will be excluded from the study.
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 |
|---|---|---|
| AssessmentAssessment of pain severity,pain thresold of the fascia, pain sensitivity | Other | back pain group, control group |
Primary outcome
Numerical Pain Scale(NMS
Time frame: 1 month
pain assessment
Fascia stiffness
Time frame: 1month
thoracolumbar fascia stiffness assessment
the Pain Sensitivity Scale(PSS)
Time frame: month
Pain sensitivity assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- 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.
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 Pain and Back Pain, run by Atılım 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 1 inclusion and 1 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 5 Aug 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 Naime Uluğ, PT,PhD (05365434409, ulugnaime@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scale(NMS (time frame: 1 month). The study lists 3 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 5 Aug 2024.