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Sponsor study identifier
interventional
49
1 country
1
Study Start
September 1, 2020
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 6, 2020
Actual (reported)August 10, 2020
Actual (reported)September 1, 2020
Actual (reported)December 31, 2022
Actual (reported)December 30, 2024
Actual (reported)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
Magnetic resonance imaging of the lumbosacral spine
pre-intervention
Total body fat content [%]
pre-intervention
Total body fat content [%]
48 hours after the intervention
Lean body mass [kg]
pre-intervention
Lean body mass [kg]
48 hours after the intervention
40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain.
20 subjects aged 35-60 with normal body weight (BMI ≤ 24.9 and ≥ 18.5 kg/m2) suffering from chronic low back pain.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Poznan University of Physical Education
Poznan, 61-871, Poland
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.
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.
Marzena Ratajczak, PhD
Poznan University of Physical Education
Małgorzata Waszak, PhD
Poznan University of Physical Education
49 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2020
First Posted
August 10, 2020
Study Start
September 1, 2020
Actual (reported)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
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
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 30, 2024
Actual (reported)Last Updated
September 23, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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