Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Obesity | Experimental | 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain. |
|
| Normal-Weight Patients | Active Comparator | 20 subjects aged 35-60 with normal body weight (BMI ≤ 24.9 and ≥ 18.5 kg/m2) suffering from chronic low back pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar traction therapy | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml] | ELISA | pre-intervention |
| Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml] | ELISA | 48 hours after the intervention |
| Stem cell growth factor β [ng/ml] | ELISA | pre-intervention |
| Stem cell growth factor β [ng/ml] | ELISA | 48 hours after the intervention |
| Leptin [ng/ml] | ELISA | pre-intervention |
| Leptin [ng/ml] | ELISA | 48 hours after the intervention |
| Adipsin [pg/ml] | ELISA | pre-intervention |
| Adipsin [pg/ml] | ELISA | 48 hours after the intervention |
| Neuropeptide Y [pg/ml] | ELISA |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic resonance imaging of the lumbosacral spine | MRI 1.5T | pre-intervention |
| Total body fat content [%] | dual energy X-ray absorptiometry (DXA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marzena Ratajczak, PhD | Poznan University of Physical Education | Principal Investigator |
| Małgorzata Waszak, PhD | Poznan University of Physical Education | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Physical Education | Poznan | 61-871 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28347933 | Background | Chow DHK, Yuen EMK, Xiao L, Leung MCP. Mechanical effects of traction on lumbar intervertebral discs: A magnetic resonance imaging study. Musculoskelet Sci Pract. 2017 Jun;29:78-83. doi: 10.1016/j.msksp.2017.03.007. Epub 2017 Mar 20. | |
| 9839819 | Background | Omarker K, Myers RR. Pathogenesis of sciatic pain: role of herniated nucleus pulposus and deformation of spinal nerve root and dorsal root ganglion. Pain. 1998 Nov;78(2):99-105. doi: 10.1016/S0304-3959(98)00119-5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009765 | Obesity |
| D007249 | Inflammation |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| pre-intervention |
| Neuropeptide Y [pg/ml] | ELISA | 48 hours after the intervention |
| Vascular Endothelial Growth Factor [pg/ml] | ELISA | pre-intervention |
| Vascular Endothelial Growth Factor [pg/ml] | ELISA | 48 hours after the intervention |
| Chondroitin sulfate CS846 [ng/mL] | ELISA | pre-intervention |
| Chondroitin sulfate CS846 [ng/mL] | ELISA | 48 hours after the intervention |
| pre-intervention |
| Total body fat content [%] | dual energy X-ray absorptiometry (DXA) | 48 hours after the intervention |
| Lean body mass [kg] | dual energy X-ray absorptiometry (DXA) | pre-intervention |
| Lean body mass [kg] | dual energy X-ray absorptiometry (DXA) | 48 hours after the intervention |
| Mobility of the spine | electrogoniometer | pre-intervention |
| Mobility of the spine | electrogoniometer | 48 hours after the intervention |
| Muscle bioelectric signal amplitude | electromyograph | pre-intervention |
| Muscle bioelectric signal amplitude | electromyograph | 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. | pre-intervention |
| Dynamic stiffness of erector spinae muscles [N/m] | Biomechanical properties will be assessed with myotonometer device. | pre-intervention |
| Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles | Biomechanical properties will be assessed with myotonometer device. | pre-intervention |
| State of tension of erector spinae muscles [Hz] | Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device. | 48 hours after the intervention |
| Dynamic stiffness of erector spinae muscles [N/m] | Biomechanical properties will be assessed with myotonometer device. | 48 hours after the intervention |
| Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles | Biomechanical properties will be assessed with myotonometer device. | 48 hours after the intervention |
| Pain threshold | algometer | pre-intervention |
| Pain threshold | algometer | 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 | 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 | 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. | 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. | 48 hours after the intervention |
| Background | Maciaszek J, Skrypnik D, Ratajczak M, Stemplewski R, Osiński W, Bogdański P, Mądry E, Walkowiak J, Karolkiewicz J. Two aerobic exercise programs in management of back pain among middle-aged obese women: A randomized controlled study. Human Movement. 2016; 17(2): 72-79. |
| 26440592 | Background | Weber KT, Satoh S, Alipui DO, Virojanapa J, Levine M, Sison C, Quraishi S, Bloom O, Chahine NO. Exploratory study for identifying systemic biomarkers that correlate with pain response in patients with intervertebral disc disorders. Immunol Res. 2015 Dec;63(1-3):170-80. doi: 10.1007/s12026-015-8709-2. |
| 30776685 | Background | Tarabeih N, Shalata A, Trofimov S, Kalinkovich A, Livshits G. Growth and differentiation factor 15 is a biomarker for low back pain-associated disability. Cytokine. 2019 May;117:8-14. doi: 10.1016/j.cyto.2019.01.011. Epub 2019 Feb 15. |
| 25367206 | Background | Sowa GA, Perera S, Bechara B, Agarwal V, Boardman J, Huang W, Camacho-Soto A, Vo N, Kang J, Weiner D. Associations between serum biomarkers and pain and pain-related function in older adults with low back pain: a pilot study. J Am Geriatr Soc. 2014 Nov;62(11):2047-55. doi: 10.1111/jgs.13102. Epub 2014 Nov 3. |
| 42367161 | Derived | Ratajczak M, Kalinkovich A, Livshits G. Vaspin-Cytokine Interactions in Chronic Low Back Pain: Links Between Obesity, Inflammation, and Traction Therapy Response. J Interferon Cytokine Res. 2026 Jun 29:10799907261465506. doi: 10.1177/10799907261465506. Online ahead of print. |
| 36927409 | Derived | Ratajczak M, Wendt M, Sliwicka E, Skrypnik D, Zielinski J, Kusy K, Krutki P, Waszak M. Subjective assessment and biochemical evaluation of traction therapy in women with chronic low back pain: does body mass index matter? A clinical study. BMC Musculoskelet Disord. 2023 Mar 16;24(1):196. doi: 10.1186/s12891-023-06300-5. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D010335 | Pathologic Processes |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |