The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
CompletedNot applicableNCT04507074
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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)…
Study details
- Official title
- The Effect of Traction Forces on Changes in Biochemical Markers of Degeneration and Functional Parameters of the Spine in People With Obesity Suffering From Chronic Low Back Pain
- Conditions
- Interventions
- Device: lumbar traction therapy
- Sponsor
- Poznan University of Physical Education
- Start date
- 2020-09-01
- Primary completion
- 2022-12-31
- Sex
- All
- Age range
- from 35 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Written consent to participate in the study, 2. Age: 35 - 60 years, 3. Obesity (BMI ≥ 30 kg / m2) or normal weight (BMI 18,5-29,9 kg/m2), 4. Stable body weight in the last month ± 2 kg, 5. Chronic low back pain. Exclusion Criteria: 1. Secondary form of obesity; 2. Serious neurological defects (including large muscle losses, sensory disturbances in a large area of the lower limb, occurrence of cauda equina syndrome); 3. Surgery, post-accident mechanical injuries, history of spine fractures; 4. History of rheumatic disease (RA, ankylosing spondylitis, systemic lupus); 5. Osteoporosis; 6. Pain located in a location other than the spine which is more severe than the low back pain; 7. Poorly controlled type 2 diabetes; 8. Poorly controlled hypertension (mean systolic blood pressure\> 140mmHg and / or average diastolic blood pressure\> 90mmHg) during the last month and / or the necessity of modification of pharmacological treatment; 9. Lipid disorders requiring the introduction of pharmacological treatment in the last 3 months before observation or during observation; 10. Acute coronary event, unstable angina, stroke or transient cerebral ischemia in the last 6 months; 11. Features of heart failure in physical examination and / or additional tests (chest X-ray, echocardiography); 12. Clinically significant arrhythmias, conduction disorders, pacemaker implantation; 13. Fainting in an interview, 14. Chronic kidney disease with creatinine clearance \<60mL / min / 1.73m2; 15. Clinically significant liver dysfunction (transaminases exceeding 3 times the normal range); 16. Acute or chronic, clinically apparent inflammatory process of the respiratory tract, inflammatory processes of the genitourinary system, inflammatory process in the head and neck; 17. Acute infection in the last month; 18. Cancer; 19. Alcohol abuse, drug addiction; 20. Pregnancy; 21. Uncontrolled mental illness that may falsify test results; 22. Other conditions which may pose any risk to the patient during the observation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04507074