The Impact Of Fascia Thickness on Chronic Low Back Pain
Relationships of Fascia Thickness With Pain, Flexibility, Disability and Depression in Individuals With Chronic Low Back Pain
1 other identifier
observational
30
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2024
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedStudy Start
First participant enrolled
September 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2024
CompletedOctober 29, 2024
October 1, 2024
1 month
August 20, 2024
October 26, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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"
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.
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
baseline
Secondary Outcomes (2)
Roland Morris Disability Questionnaire (RMDQ)
baseline
Beck Depression Inventory
baseline
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Getting a diagnosis of low back pain
You may qualify if:
- 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.
You may not qualify if:
- History of musculoskeletal diseases,
- a history of back and lower limb surgery,
- the use of anti-inflammatory drugs and steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
Study Sites (2)
Emine Atıcı
Tuzla, Istanbul, Turkey (Türkiye)
Istanbul Okan University
Istanbul, 34959, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emine Atıcı
Okan University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 26, 2024
Study Start
September 15, 2024
Primary Completion
October 25, 2024
Study Completion
October 25, 2024
Last Updated
October 29, 2024
Record last verified: 2024-10