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NCT04507074

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

Completed NA Last updated 23 September 2025
What this trial tests

NA trial testing lumbar traction therapy in Low Back Pain in 49 participants. Completed in 30 December 2024.

Timeline
1 September 2020
Primary endpoint
31 December 2022
30 December 2024

Quick facts

Lead sponsorPoznan University of Physical Education
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment49
Start date1 September 2020
Primary completion31 December 2022
Estimated completion30 December 2024
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Poznan University of Physical Education

Who can join

Adults 35 to 60, any sex, with Low Back Pain or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Subjective assessment and biochemical evaluation of traction therapy in women with chronic low back pain: does body mass index matter? A clinical study.
    Ratajczak M, Wendt M, Śliwicka E, Skrypnik D, et al · · 2023 · cited 6× · PMID 36927409 · DOI 10.1186/s12891-023-06300-5
  2. In search of biomarkers for low back pain: can traction therapy effectiveness be prognosed by surface electromyography or blood parameters?
    Ratajczak M, Waszak M, Śliwicka E, Wendt M, et al · · 2023 · cited 1× · PMID 38143914 · DOI 10.3389/fphys.2023.1290409
  3. Bone remodelling after application of traction forces to the lumbar spine in women with chronic low back pain.
    Ratajczak M, Kusy K, Skrypnik D, Waszak M, et al · · 2025 · PMID 40754314 · DOI 10.1302/2046-3758.148.bjr-2024-0465.r1

Verify or expand the search:

Other recruiting trials for Low Back Pain

Currently open trials in the same condition.

Other Poznan University of Physical Education trials

Trials by the same sponsor.

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