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NCT04507074Completed

The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain

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

Source: ClinicalTrials.gov · Last updated 23 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
49 (actual)
First submitted
6 Jul 2020
Start date
1 Sept 2020
Primary completion date
31 Dec 2022
Lead sponsor
Poznan University of Physical Education
Diseases
Obesity
NCT number
NCT04507074

What you commit to

  • Study type: Interventional
  • Participants enrolled: 49
  • From 1 Sept 2020 to the primary completion date, 31 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Lipid disorders requiring the introduction of pharmacological treatment in the last 3 months before observation or during observation;
  • Alcohol abuse, drug addiction;

Other illness

  • Serious neurological defects (including large muscle losses, sensory disturbances in a large area of the lower limb, occurrence of cauda equina syndrome);
  • Surgery, post-accident mechanical injuries, history of spine fractures;
  • History of rheumatic disease (RA, ankylosing spondylitis, systemic lupus);
  • Poorly controlled type 2 diabetes;
  • 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;
  • Acute coronary event, unstable angina, stroke or transient cerebral ischemia in the last 6 months;
  • Features of heart failure in physical examination and / or additional tests (chest X-ray, echocardiography);
  • Clinically significant arrhythmias, conduction disorders, pacemaker implantation;
  • Acute infection in the last month;
  • Cancer;
  • Uncontrolled mental illness that may falsify test results;
  • Other conditions which may pose any risk to the patient during the observation.

Lab values

  • Chronic kidney disease with creatinine clearance \<60mL / min / 1.73m2;
  • Clinically significant liver dysfunction (transaminases exceeding 3 times the normal range);

Other

  • Secondary form of obesity;
  • Osteoporosis;
  • Pain located in a location other than the spine which is more severe than the low back pain;
  • Fainting in an interview,
  • Acute or chronic, clinically apparent inflammatory process of the respiratory tract, inflammatory processes of the genitourinary system, inflammatory process in the head and neck;
  • Pregnancy;

Who the study is looking for

  • Written consent to participate in the study,
  • Age: 35 - 60 years,
  • Obesity (BMI ≥ 30 kg / m2) or normal weight (BMI 18,5-29,9 kg/m2),
  • Stable body weight in the last month ± 2 kg,
  • Chronic low back pain.

Age in the registry: 35 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Poznan University of Physical Education
Coordinator of this site? Confirm its status		PoznanPolandUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.