Low Back PainNCT05366972
Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain
A study testing Ultrasonographic measurements in people with Low Back Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.There is still no standard method for imaging and analyzing the thoracolumbar fascia.The aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Ultrasonographic measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2022to 15 Jul 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-65 years old
- Patients with low back pain for more than 6 months
- Healthy volunteers
Who cannot join
- Previous low back or back surgery
- Uncontrolled Diabetes Mellitus
- Mental retardation
- Metabolic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain
Recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.There is still no standard method for imaging and analyzing the thoracolumbar fascia.The aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low back pain as well as to advance the analysis methods.
- Conditions
- Low Back Pain
- Being tested
- Ultrasonographic measurements
- 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.
Ultrasonographic measurementsDevice
Posterior layers of the thoracolumbar fascia ,middle layers of the thoracolumbar fascia thickness and Lumbar interfacial triangle thickness
CSA (cross-sectional area) measurements of erector spinae muscles, quadratus lumborum muscles and the latissimus dorsi muscles
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with low back pain | Active comparator | Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography. Receives: Device: Ultrasonographic measurements |
| Healthy volunteers | Active comparator | Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography. Receives: Device: Ultrasonographic measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
fascia thickness
The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.
Measured: 20 minutes
Secondary outcomes (3)
CSA
CSA (Sectional Area) measurements of erector spina ,quadratus lumborum and latissimus dorsi muscles by ultrasonography
Measured: 20 minute
VAS
visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
Measured: 20 minutes
ODİ
Oswestry Disability Index Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.(1)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start10 May 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Burcu Metin Ökmen, Assoc. PhD., Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366972
- Sponsor's protocol ID
- 2020/06-24
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PubMed 11074683
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT05366972
- Acronym / sponsor ID
- 2020/06-24
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 10 May 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 10 May 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.
Recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.There is still no standard method for imaging and analyzing the thoracolumbar fascia.The aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low back pain as well as to advance the analysis methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with low back pain | Active comparator | Device: Ultrasonographic measurementsMeasurements of the back muscles and thoracolumbar fascia will be made by ultrasonography. |
| Healthy volunteers | Active comparator | Device: Ultrasonographic measurementsMeasurements of the back muscles and thoracolumbar fascia will be made by ultrasonography. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-65 years old
- Patients with low back pain for more than 6 months
- Healthy volunteers
Key exclusion criteria (4 listed)
- Previous low back or back surgery
- Uncontrolled Diabetes Mellitus
- Mental retardation
- Metabolic disorders
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 |
|---|---|---|
| Ultrasonographic measurementsPosterior layers of the thoracolumbar fascia ,middle layers of the thoracolumbar fascia thickness and Lumbar interfacial triangle thickness CSA (cross-sectional area) measurements of erector spinae muscles, quadratus lumborum muscles and the latissimus dorsi muscles | Device | Healthy volunteers, Patients diagnosed with low back pain |
Primary outcome
fascia thickness
Time frame: 20 minutes
The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.
3 secondary outcomes
CSA
Time frame: 20 minute
VAS
Time frame: 20 minutes
ODİ
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Results publication: PubMed 11074683Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
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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.
Burcu Metin Ökmen, Assoc. PhD. study chair
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic measurements in people with Low Back Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 3 inclusion and 4 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 12 May 2022. 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 Korgün Ökmen, Assoc. PhD. (+905057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fascia thickness (time frame: 20 minutes). 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 NCT05366972, which also lists 1 linked publication.
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 12 May 2022.