The purpose of the research study is to assess the impact of traction forces on changes in systemic markers concentrations of spinal structure damage in people with obesity. The research group will include 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic lumbar spine pain syndrome. The control group will consist of 20 subjects with normal body weight suffering from the same pain, at a similar age to the patients in the study group. Persons will be qualified for examination by a specialist in internal medicine and a physiotherapist. To assess the degree of structural damage within the intervertebral disc and adjacent anatomical structures, patients will undergo magnetic resonance imaging of the lumbosacral spine (MRI 1.5T, standard in 3 projections). Patients will undergo traction therapy under the supervision of a physiotherapist. The application of traction forces on the traction table (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with a maximum strength of 30% of the patient's body weight). Twice, before and after therapy, the following will be assessed: (1) body composition (by DXA method), (2) other anthropometric indicators, (3) functional parameters of the spine: mobility (electrogoniometer), muscle bioelectric signal amplitude (electromyograph), soft tissue biophysical parameters (myotonometer), (4) pain threshold and intensity in the lumbar region (using an algometer and validated questionnaires), (5) disability caused by pain in the spine (Oswestry questionnaire), (6) blood biochemical indicators selected on the basis of the latest research on biomarkers of spinal damage (for this purpose, 25ml venous blood will be taken from the subjects). Blood levels of interleukin-17, interleukin-4, interleukin-2 (IL-2), interleukin-10 (IL-10), differentiating growth factor 15 (GDF-15), leptin, adipsin, chemokine CCL5 (RANTES), stem cell growth factor β (SCGF-β), vascular endothelial growth factor (VEGF), neuropeptide Y, and chondroitin sulfate CS846 will be determined in the blood of the subjects. It is planned to assess the relationship of the studied biomarkers with the degree of disk degeneration, obesity, lean and fat body mass, pain intensity, and functional indicators of the spine. Patients will be asked to stop taking anti-inflammatory drugs during therapy and at least 24 hours prior to blood sampling.
People suffering from obesity are particularly vulnerable to mechanical compression of the intervertebral discs, and as a result their degeneration, hernia and pressure on the nerve roots, which together cause inflammation and pain in the damaged area. This is a significant public health problem due to the 100% incidence of pain syndrome among people with obesity. The use of traction forces has beneficial effects on degenerated intervertebral discs, but there are no studies assessing the effectiveness of the traction method in relation to a group of obese people with back pain syndrome. Beneficial biochemical changes in the blood, alleviation of pain, improvement of functional parameters of the spine are expected after application of traction forces to the patients in the mechanism of decompression of the destroyed and being in chronic inflammation intervertebral discs. Identification of biomarkers enabling to monitor the effects of therapies in patients with chronic back pain can become a contribution to change standards in the diagnosis of back pain and reorientation in its treatment to real causes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
49
The application of traction forces on the traction table (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with a maximum strength of 30% of the patient's body weight).
Poznan University of Physical Education
Poznan, Poland
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
ELISA
Time frame: pre-intervention
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
ELISA
Time frame: 48 hours after the intervention
Stem cell growth factor β [ng/ml]
ELISA
Time frame: pre-intervention
Stem cell growth factor β [ng/ml]
ELISA
Time frame: 48 hours after the intervention
Leptin [ng/ml]
ELISA
Time frame: pre-intervention
Leptin [ng/ml]
ELISA
Time frame: 48 hours after the intervention
Adipsin [pg/ml]
ELISA
Time frame: pre-intervention
Adipsin [pg/ml]
ELISA
Time frame: 48 hours after the intervention
Neuropeptide Y [pg/ml]
ELISA
Time frame: pre-intervention
Neuropeptide Y [pg/ml]
ELISA
Time frame: 48 hours after the intervention
Vascular Endothelial Growth Factor [pg/ml]
ELISA
Time frame: pre-intervention
Vascular Endothelial Growth Factor [pg/ml]
ELISA
Time frame: 48 hours after the intervention
Chondroitin sulfate CS846 [ng/mL]
ELISA
Time frame: pre-intervention
Chondroitin sulfate CS846 [ng/mL]
ELISA
Time frame: 48 hours after the intervention
Magnetic resonance imaging of the lumbosacral spine
MRI 1.5T
Time frame: pre-intervention
Total body fat content [%]
dual energy X-ray absorptiometry (DXA)
Time frame: pre-intervention
Total body fat content [%]
dual energy X-ray absorptiometry (DXA)
Time frame: 48 hours after the intervention
Lean body mass [kg]
dual energy X-ray absorptiometry (DXA)
Time frame: pre-intervention
Lean body mass [kg]
dual energy X-ray absorptiometry (DXA)
Time frame: 48 hours after the intervention
Mobility of the spine
electrogoniometer
Time frame: pre-intervention
Mobility of the spine
electrogoniometer
Time frame: 48 hours after the intervention
Muscle bioelectric signal amplitude
electromyograph
Time frame: pre-intervention
Muscle bioelectric signal amplitude
electromyograph
Time frame: 48 hours after the intervention
State of tension of erector spinae muscles [Hz]
Natural oscillation frequency \[Hz\], characterizing Tone or Tension will be assessed with myotonometer device.
Time frame: pre-intervention
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Dynamic stiffness of erector spinae muscles [N/m]
Biomechanical properties will be assessed with myotonometer device.
Time frame: pre-intervention
Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
Biomechanical properties will be assessed with myotonometer device.
Time frame: pre-intervention
State of tension of erector spinae muscles [Hz]
Natural oscillation frequency \[Hz\], characterizing Tone or Tension will be assessed with myotonometer device.
Time frame: 48 hours after the intervention
Dynamic stiffness of erector spinae muscles [N/m]
Biomechanical properties will be assessed with myotonometer device.
Time frame: 48 hours after the intervention
Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
Biomechanical properties will be assessed with myotonometer device.
Time frame: 48 hours after the intervention
Pain threshold
algometer
Time frame: pre-intervention
Pain threshold
algometer
Time frame: 48 hours after the intervention
Pain intensity: questionnaire
visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable
Time frame: pre-intervention
Pain intensity: questionnaire
visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable
Time frame: 48 hours after the intervention
Disability caused by pain in the spine
Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.
Time frame: pre-intervention
Disability caused by pain in the spine
Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.
Time frame: 48 hours after the intervention