CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
lumbar traction therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04507074
NCT04507074N/ACompleted

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

Poznan University of Physical Education·interventional·Posted Aug 10, 2020·Updated Sep 23, 2025

In Brief

A clinical study evaluating lumbar traction therapy for Low Back Pain and Obesity. Completed, enrolled 49 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 10, 2020
Enrollment StartSep 1, 2020
Primary CompletionDec 31, 2022
Study CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.9 years ago

Interventions

lumbar traction therapydevice

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).