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CompletedNCT04507074Updated Sep 23, 2025

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

An interventional study of lumbar traction therapy in Low Back Pain and Obesity, sponsored by Poznan University of Physical Education. Completed at 1 site in Poland. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
35 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

People suffering from obesity are particularly vulnerable to mechanical compression of the intervertebral discs, and as a result their degeneration, hernia and pressure on the nerve roots, which together cause inflammation and pain in the damaged area. This is a significant public health problem due to the 100% incidence of pain syndrome among people with obesity. The use of traction forces has beneficial effects on degenerated intervertebral discs, but there are no studies assessing the effectiveness of the traction method in relation to a group of obese people with back pain syndrome.

Beneficial biochemical changes in the blood, alleviation of pain, improvement of functional parameters of the spine are expected after application of traction forces to the patients in the mechanism of decompression of the destroyed and being in chronic inflammation intervertebral discs. Identification of biomarkers enabling to monitor the effects of therapies in patients with chronic back pain can become a contribution to change standards in the diagnosis of back pain and reorientation in its treatment to real causes.

02

Conditions studied

  • Low Back Pain
  • Obesity

Keywords

  • biomarkers of low back pain
  • inflammation
  • disk degeneration
  • traction therapy
  • lumbar traction
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 49 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Patients With Obesity

    40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain.

    Device: lumbar traction therapy

  • Active comparator
    Normal-Weight Patients

    20 subjects aged 35-60 with normal body weight (BMI ≤ 24.9 and ≥ 18.5 kg/m2) suffering from chronic low back pain.

    Device: lumbar traction therapy

Interventions

  • Devicelumbar traction therapy

    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).

    Also known as: lumbar traction

06

What researchers measure

Primary outcomes

  1. Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]

    ELISA

    Time frame: pre-intervention

  2. Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]

    ELISA

    Time frame: 48 hours after the intervention

  3. Stem cell growth factor β [ng/ml]

    ELISA

    Time frame: pre-intervention

  4. Stem cell growth factor β [ng/ml]

    ELISA

    Time frame: 48 hours after the intervention

  5. Leptin [ng/ml]

    ELISA

    Time frame: pre-intervention

  6. Leptin [ng/ml]

    ELISA

    Time frame: 48 hours after the intervention

  7. Adipsin [pg/ml]

    ELISA

    Time frame: pre-intervention

  8. Adipsin [pg/ml]

    ELISA

    Time frame: 48 hours after the intervention

  9. Neuropeptide Y [pg/ml]

    ELISA

    Time frame: pre-intervention

  10. Neuropeptide Y [pg/ml]

    ELISA

    Time frame: 48 hours after the intervention

  11. Vascular Endothelial Growth Factor [pg/ml]

    ELISA

    Time frame: pre-intervention

  12. Vascular Endothelial Growth Factor [pg/ml]

    ELISA

    Time frame: 48 hours after the intervention

  13. Chondroitin sulfate CS846 [ng/mL]

    ELISA

    Time frame: pre-intervention

  14. Chondroitin sulfate CS846 [ng/mL]

    ELISA

    Time frame: 48 hours after the intervention

Secondary outcomes

  1. Magnetic resonance imaging of the lumbosacral spine

    MRI 1.5T

    Time frame: pre-intervention

  2. Total body fat content [%]

    dual energy X-ray absorptiometry (DXA)

    Time frame: pre-intervention

  3. Total body fat content [%]

    dual energy X-ray absorptiometry (DXA)

    Time frame: 48 hours after the intervention

  4. Lean body mass [kg]

    dual energy X-ray absorptiometry (DXA)

    Time frame: pre-intervention

  5. Lean body mass [kg]

    dual energy X-ray absorptiometry (DXA)

    Time frame: 48 hours after the intervention

  6. Mobility of the spine

    electrogoniometer

    Time frame: pre-intervention

  7. Mobility of the spine

    electrogoniometer

    Time frame: 48 hours after the intervention

  8. Muscle bioelectric signal amplitude

    electromyograph

    Time frame: pre-intervention

  9. Muscle bioelectric signal amplitude

    electromyograph

    Time frame: 48 hours after the intervention

  10. State of tension of erector spinae muscles [Hz]

    Natural oscillation frequency \[Hz\], characterizing Tone or Tension will be assessed with myotonometer device.

    Time frame: pre-intervention

  11. Dynamic stiffness of erector spinae muscles [N/m]

    Biomechanical properties will be assessed with myotonometer device.

    Time frame: pre-intervention

  12. Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles

    Biomechanical properties will be assessed with myotonometer device.

    Time frame: pre-intervention

  13. State of tension of erector spinae muscles [Hz]

    Natural oscillation frequency \[Hz\], characterizing Tone or Tension will be assessed with myotonometer device.

    Time frame: 48 hours after the intervention

  14. Dynamic stiffness of erector spinae muscles [N/m]

    Biomechanical properties will be assessed with myotonometer device.

    Time frame: 48 hours after the intervention

  15. Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles

    Biomechanical properties will be assessed with myotonometer device.

    Time frame: 48 hours after the intervention

  16. Pain threshold

    algometer

    Time frame: pre-intervention

  17. Pain threshold

    algometer

    Time frame: 48 hours after the intervention

  18. Pain intensity: questionnaire

    visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable

    Time frame: pre-intervention

  19. Pain intensity: questionnaire

    visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable

    Time frame: 48 hours after the intervention

  20. Disability caused by pain in the spine

    Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.

    Time frame: pre-intervention

  21. Disability caused by pain in the spine

    Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.

    Time frame: 48 hours after the intervention

07

Study locations

1 site
  • Poznan University of Physical Education
    Poznan, 61-871, Poland
08

References and documents

Publications

  • Chow DHK, Yuen EMK, Xiao L, Leung MCP. Mechanical effects of traction on lumbar intervertebral discs: A magnetic resonance imaging study. Musculoskelet Sci Pract. 2017 Jun;29:78-83. doi: 10.1016/j.msksp.2017.03.007. Epub 2017 Mar 20. PubMed 28347933 ↗
  • Omarker K, Myers RR. Pathogenesis of sciatic pain: role of herniated nucleus pulposus and deformation of spinal nerve root and dorsal root ganglion. Pain. 1998 Nov;78(2):99-105. doi: 10.1016/S0304-3959(98)00119-5. PubMed 9839819 ↗
  • Maciaszek J, Skrypnik D, Ratajczak M, Stemplewski R, Osiński W, Bogdański P, Mądry E, Walkowiak J, Karolkiewicz J. Two aerobic exercise programs in management of back pain among middle-aged obese women: A randomized controlled study. Human Movement. 2016; 17(2): 72-79.
  • Weber KT, Satoh S, Alipui DO, Virojanapa J, Levine M, Sison C, Quraishi S, Bloom O, Chahine NO. Exploratory study for identifying systemic biomarkers that correlate with pain response in patients with intervertebral disc disorders. Immunol Res. 2015 Dec;63(1-3):170-80. doi: 10.1007/s12026-015-8709-2. PubMed 26440592 ↗
  • Tarabeih N, Shalata A, Trofimov S, Kalinkovich A, Livshits G. Growth and differentiation factor 15 is a biomarker for low back pain-associated disability. Cytokine. 2019 May;117:8-14. doi: 10.1016/j.cyto.2019.01.011. Epub 2019 Feb 15. PubMed 30776685 ↗
  • Sowa GA, Perera S, Bechara B, Agarwal V, Boardman J, Huang W, Camacho-Soto A, Vo N, Kang J, Weiner D. Associations between serum biomarkers and pain and pain-related function in older adults with low back pain: a pilot study. J Am Geriatr Soc. 2014 Nov;62(11):2047-55. doi: 10.1111/jgs.13102. Epub 2014 Nov 3. PubMed 25367206 ↗
  • Ratajczak M, Kalinkovich A, Livshits G. Vaspin-Cytokine Interactions in Chronic Low Back Pain: Links Between Obesity, Inflammation, and Traction Therapy Response. J Interferon Cytokine Res. 2026 Jun 29:10799907261465506. doi: 10.1177/10799907261465506. Online ahead of print. PubMed 42367161 ↗
  • Ratajczak M, Wendt M, Sliwicka E, Skrypnik D, Zielinski J, Kusy K, Krutki P, Waszak M. Subjective assessment and biochemical evaluation of traction therapy in women with chronic low back pain: does body mass index matter? A clinical study. BMC Musculoskelet Disord. 2023 Mar 16;24(1):196. doi: 10.1186/s12891-023-06300-5. PubMed 36927409 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04507074
Lead sponsor
Poznan University of Physical Education
Responsible party
Marzena Ratajczak (assistant professor, Poznan University of Physical Education) — Principal investigator
First posted
Aug 10, 2020
Start date
Sep 1, 2020
Primary completion
Dec 31, 2022
Completion
Dec 30, 2024
Last update
Sep 23, 2025

Study contacts

Marzena Ratajczak, PhD
principal investigator · Poznan University of Physical Education
Małgorzata Waszak, PhD
study chair · Poznan University of Physical Education

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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