Low Back PainNCT06572007
The Impact Of Fascia Thickness on Chronic Low Back Pain
An observational study of Low Back Pain and Disability Physical, run by Okan University at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to investigate the impact of lumbar perimuscular and subcutaneous zone thickness on pain, functionality, disability, and depression in individuals with chronic low back pain (CLBP). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Low Back Pain, Disability Physical, Pain, Chronic
- What is being tested?
- Ultrasound
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 25 Oct 2024
- How long will I take part?
- 3 Months
- 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 30 to 50 years
- All sexes
- Adult
Study population: Getting a diagnosis of low back pain
Who may be able to join
- The absence of LBP in the last 12 months,
- A body mass index (BMI) of 18.5 to 30,
- An age between 30 and 50 years.
Who cannot join
- History of musculoskeletal diseases,
- a history of back and lower limb surgery,
- the use of anti-inflammatory drugs and steroids
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Okan University
Istanbul, 34959
Emine Atıcı
Tuzla, Istanbul
About this study
Official title: Relationships of Fascia Thickness With Pain, Flexibility, Disability and Depression in Individuals With Chronic Low Back Pain
This study aimed to investigate the impact of lumbar perimuscular and subcutaneous zone thickness on pain, functionality, disability, and depression in individuals with chronic low back pain (CLBP).
Read the detailed description
This study investigates the role of the thoracolumbar fascia (TLF) in chronic low back pain (CLBP) persisting for more than one year. Specifically, the researchers aim to examine the relationships between various factors in individuals with CLBP, including the thickness of the perimuscular and subcutaneous regions in the lumbar and hamstring regions. The relationship with functional tests of the lower back and lower limbs will also be analysed. In addition, the intensity of the pain experienced by the participants, the extent to which the pain restricts their daily activities, and depression scores will be assessed. Through this analysis, the researchers aim to gain a deeper understanding of TLF's involvement in CLBP and its impact on the overall well-being of affected individuals.
- Conditions
- Low Back Pain, Disability Physical, Pain, Chronic
- Being tested
- Ultrasound
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
To investigate the thickness of the fascia tissue, the subjects will undergo an ultrasound examination using a clinical ultrasound system (S9, SonoScape Corporation, made in China) with a linear 5-14 MHz array of L14-5/38. The transducer with a cross-section of 6.24 cm2 will be aimed at points 2 cm lateral to the midline of the L2 and L3 vertebrae on both sides of the spine.
| Study group | Role | What they receive |
|---|---|---|
| Low back pain | Fascia thickness of individuals with chronic low back pain will be measured by ultrasound and the relationship with pain, flexibility, disability and depression will be analysed. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale, a 100 mm long scale marked at every 10 mm and ranging from 0 to 10, will be used to assess the level of pain. Patients mark their own pain level on this scale, scoring between 0 and 10, where 0 indicates "no pain" and 10 represents "the worst possible pain"
Measured: baseline
Straight Leg Raise Test (SLR)
The Straight Leg Raise Test is a physiotherapy method used to determine the range of motion of the hip joint. The patient lies supine. They are instructed to lift one leg as high as possible without bending the knee. The leg that remains on the ground should not lift, and its knee should remain extended. The point reached by the raised leg is measured with a goniometer. The same procedure is repeated for the other leg . Normally, the hip flexion angle is 90 degrees; a range of 70-90 degrees is considered normal in adults. An angle below 70 degrees indicates restriction.
Measured: baseline
Lumbar Extensor Shortening Assessment
This physiotherapy method is used to evaluate the shortening of the extensor muscles in the lumbar region. The patient lies supine with their arms in a reverse 'T' position. They are instructed to flex both hips and knees and draw them towards their abdomen. The distance between the knees and the chest is recorded
Measured: baseline
Secondary outcomes (2)
Roland Morris Disability Questionnaire (RMDQ)
The Turkish version of the Roland Morris Disability Questionnaire will be used to measure disability. The RMDQ, first published in 1983, assesses the disability level of individuals with back pain(23). It consists of 24 items, including physical ability/activity (15 items), sleep/rest (3 items), psychosocial (2 items), home management (2 items), eating (1 item), and pain frequency (1 item). The original 24-item questionnaire has been shortened to 18-item and 23-item versions and adapted for use in other countries . It was adapted into Turkish by Küçükdeveci et al. in 2001. Each positive response corresponds to one point on the scale, addressing daily activities potentially restricted by back pain. Each "Yes" answer scores 1 point, and each "No" answer scores 0 points, with the final score being the sum of these points. The total score ranges from 0 to 24, with higher scores indicating greater disability .
Measured: baseline
Beck Depression Inventory
The Turkish version of the Beck Depression Inventory, developed by Beck and colleagues, will be used. Adapted into Turkish by Hisli N. in 1988, the inventory consists of 21 questions, each separately scored to obtain a total score. The possible scores range from 0 to 63. Scores of 0-9 indicate minimal depression, 10-16 mild depression, 17-29 moderate depression, and 30-63 severe depression
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 Aug 2024
- Study start15 Sep 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
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.
- 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
- 30 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
- Investigators
- Emine Atıcı, Study director, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572007
- Sponsor's protocol ID
- 26.10.2022/159
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships of Fascia Thickness With Pain, Flexibility, Disability and Depression in Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06572007
- Acronym / sponsor ID
- 26.10.2022/159
- Conditions
- Low Back Pain, Disability Physical, Pain, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 26 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 aimed to investigate the impact of lumbar perimuscular and subcutaneous zone thickness on pain, functionality, disability, and depression in individuals with chronic low back pain (CLBP).
Detailed description
This study investigates the role of the thoracolumbar fascia (TLF) in chronic low back pain (CLBP) persisting for more than one year. Specifically, the researchers aim to examine the relationships between various factors in individuals with CLBP, including the thickness of the perimuscular and subcutaneous regions in the lumbar and hamstring regions. The relationship with functional tests of the lower back and lower limbs will also be analysed. In addition, the intensity of the pain experienced by the participants, the extent to which the pain restricts their daily activities, and depression scores will be assessed. Through this analysis, the researchers aim to gain a deeper understanding of TLF's involvement in CLBP and its impact on the overall well-being of affected individuals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low back pain | – | Diagnostic Test: UltrasoundFascia thickness of individuals with chronic low back pain will be measured by ultrasound and the relationship with pain, flexibility, disability and depression will be analysed. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Getting a diagnosis of low back pain
Key inclusion criteria (3 listed)
- The absence of LBP in the last 12 months,
- A body mass index (BMI) of 18.5 to 30,
- An age between 30 and 50 years.
Key exclusion criteria (3 listed)
- History of musculoskeletal diseases,
- a history of back and lower limb surgery,
- the use of anti-inflammatory drugs and steroids
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 |
|---|---|---|
| UltrasoundTo investigate the thickness of the fascia tissue, the subjects will undergo an ultrasound examination using a clinical ultrasound system (S9, SonoScape Corporation, made in China) with a linear 5-14 MHz array of L14-5/38. The transducer with a cross-section of 6.24 cm2 will be aimed at points 2 cm lateral to the midline of the L2 and L3 vertebrae on both sides of the spine. | Diagnostic test | Low back pain |
Primary outcome
Visual Analog Scale (VAS)
Time frame: baseline
The Visual Analog Scale, a 100 mm long scale marked at every 10 mm and ranging from 0 to 10, will be used to assess the level of pain. Patients mark their own pain level on this scale, scoring between 0 and 10, where 0 indicates "no pain" and 10 represents "the worst possible pain"
Straight Leg Raise Test (SLR)
Time frame: baseline
The Straight Leg Raise Test is a physiotherapy method used to determine the range of motion of the hip joint. The patient lies supine. They are instructed to lift one leg as high as possible without bending the knee. The leg that remains on the ground should not lift, and its knee should remain extended. The point reached by the raised leg is measured with a goniometer. The same procedure is repeated for the other leg . Normally, the hip flexion angle is 90 degrees; a range of 70-90 degrees is considered normal in adults. An angle below 70 degrees indicates restriction.
Lumbar Extensor Shortening Assessment
Time frame: baseline
This physiotherapy method is used to evaluate the shortening of the extensor muscles in the lumbar region. The patient lies supine with their arms in a reverse 'T' position. They are instructed to flex both hips and knees and draw them towards their abdomen. The distance between the knees and the chest is recorded
2 secondary outcomes
Roland Morris Disability Questionnaire (RMDQ)
Time frame: baseline
Beck Depression Inventory
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 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Emine Atıcı study director
Okan University
2 sites 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 and Disability Physical, run by Okan University at 2 sites 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 3 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analog Scale (VAS) (time frame: baseline). 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 29 Oct 2024.