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NCT04507074
The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
NA trial testing lumbar traction therapy in Low Back Pain in 49 participants. Completed in 30 December 2024.
31 December 2022
Quick facts
| Lead sponsor | Poznan University of Physical Education |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 49 |
| Start date | 1 September 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- lumbar traction therapy
Conditions studied
- Low Back Pain — all drugs for Low Back Pain →
- Obesity — all drugs for Obesity →
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):
-
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 -
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 -
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:
- PubMed search for NCT04507074
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04507074 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poznan University of Physical Education
- Last refreshed: 23 September 2025
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