Clinical trial NCT05503121: Relationship Between Biomarkers and Biomechanical in Nonspecific Low Back Pain
Official title: Investigation of the Relationship Between Biomarkers and Biomechanical Properties in Individuals With Nonspecific Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: Biomarker
Biomechanic
Nonspecific low back pain
3D motion analysis system
sEMG
Lead sponsor: Istinye University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-08-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18-45 who have had nonspecific low back pain.

Brief summary: Nonspecific low back pain is one of the most common health problems today. Although it is encountered so frequently, the relationships between the symptoms of patients who complain of low back pain have not been fully explained.

With pain, changes occur in the body of individuals. When the blood values of individuals are examined, changes are observed in their biomarkers. Two of these biomarkers are anti-inflammatory and pro-inflammatory biomarkers. These two biomarkers indicate that there is an inflammation in the body. Inflammation can cause pain. Pain also prevents individuals from performing their movements correctly and can cause individuals to make biomechanical changes in their bodies that will make them feel less pain. Clinicians and physiotherapists treat symptoms for pain, patients' pain starts again or does not go away at all because the underlying problem is not fully understood and resolved.

Biomechanical features that can be explained as muscle activation and joint movements can be defined as the lowest unit of functional movement. These movements combine to form functions. When we search for functionality in the literature, we see that the functionality increases with the decrease of inflammation. Functions performed in a different way than normal due to pain and changes in these functions may or may not be at an observable level. For this reason, the biomechanical changes of individuals with pain will be analyzed with a more detailed and objective measurement system.

The three-dimensional motion analysis system and muscle activation measuring devices to be used in this study are devices that can make the most accurate and precise measurement and allow us to examine the lowest unit of motion. This study will go to the basis of the movement and understand the problems there and will contribute to the production of permanent solutions in future studies.

Pain and biomarkers and pain and biomechanical properties were evaluated separately in the studies, no study was found that examined biomechanical properties and biomarkers together. The aim of the project is to examine the relationship between inflammation and biomechanical properties. At the end of the project, the relationship between inflammation and biomechanical changes in low back pain will be demonstrated objectively, and it is anticipated that new treatment strategies can be developed for nonspecific low back pain.


Eligibility criteria: Inclusion Criteria:

* Nonspecific low back pain diagnosed by a physical therapy and rehabilitation specialist,
* For participants with pain, those who defined their pain on a scale of 3-7 on VAS,
* Individuals between the ages of 18-45 who have had pain in the lumbar region for at least 3 months,
* Those who do not have an infectious condition for any other reason (gum infection, metabolic diseases, viral infections, etc.) will be included in the study.

Exclusion Criteria:

* Diagnosed with disc herniation,
* diagnosed with scoliosis,
* Lumbal spine surgery or lumbar spine trauma,
* Those with a history of spine infection, tumor, osteoporosis, structural deformity, cauda equina syndrome, radicular syndrome,
* Those who participated in the period 1 week before and 1 week after the menstrual cycle,
* Diagnosed with rheumatic disease,
* Individuals with difficulty in cooperation and
* Individuals who received physical therapy within 3 months will not be included in the study.

Primary outcomes:
measure: Motion analysis
timeFrame: baseline
measure: Muscle activation
timeFrame: baseline
measure: Short Form McGill Pain Questionnaire
timeFrame: baseline
measure: Analysis of Inflammatory Markers (Interleukin-1Beta, Tumor Necrosis Factor Alpha, Interleukin-6, Interleukin-2, Interleukin-8, Interleukin-10 )
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: