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

NCT04507074 | Completed

• 1 other identifier: PoznanUPhyEd no. 3
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain; Obesity

Keywords

biomarkers of low back pain; inflammation; disk degeneration; traction therapy; lumbar traction

Outcome Measures

Primary Outcomes (14)

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

  ELISA

  pre-intervention

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

  ELISA

  48 hours after the intervention

• Stem cell growth factor β [ng/ml]

  ELISA

  pre-intervention

• Stem cell growth factor β [ng/ml]

  ELISA

  48 hours after the intervention

• Leptin [ng/ml]

  ELISA

  pre-intervention

• Leptin [ng/ml]

  ELISA

  48 hours after the intervention

• Adipsin [pg/ml]

  ELISA

  pre-intervention

• Adipsin [pg/ml]

  ELISA

  48 hours after the intervention

• Neuropeptide Y [pg/ml]

  ELISA

  pre-intervention

• Neuropeptide Y [pg/ml]

  ELISA

  48 hours after the intervention

• Vascular Endothelial Growth Factor [pg/ml]

  ELISA

  pre-intervention

• Vascular Endothelial Growth Factor [pg/ml]

  ELISA

  48 hours after the intervention

• Chondroitin sulfate CS846 [ng/mL]

  ELISA

  pre-intervention

• Chondroitin sulfate CS846 [ng/mL]

  ELISA

  48 hours after the intervention

Secondary Outcomes (21)

• Magnetic resonance imaging of the lumbosacral spine

  pre-intervention

• Total body fat content [%]

  pre-intervention

• Total body fat content [%]

  48 hours after the intervention

• Lean body mass [kg]

  pre-intervention

• Lean body mass [kg]

  48 hours after the intervention

Study Arms (2)

Patients With Obesity

EXPERIMENTAL

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

Device: lumbar traction therapy

Normal-Weight Patients

ACTIVE COMPARATOR

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

lumbar traction therapy DEVICE

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

Normal-Weight Patients; Patients With Obesity

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Secondary form of obesity;
• 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);
• Osteoporosis;
• Pain located in a location other than the spine which is more severe than the low back pain;
• 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;
• Lipid disorders requiring the introduction of pharmacological treatment in the last 3 months before observation or during observation;
• 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;
• Fainting in an interview,
• Chronic kidney disease with creatinine clearance \<60mL / min / 1.73m2;
• Clinically significant liver dysfunction (transaminases exceeding 3 times the normal range);

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, 61-871, Poland

Location

Related Publications (7)

• 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.

  PMID: 28347933 BACKGROUND

• 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.

  PMID: 9839819 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26440592 BACKGROUND

• 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.

  PMID: 30776685 BACKGROUND

• 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.

  PMID: 25367206 BACKGROUND

• 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.

  PMID: 36927409 DERIVED

MeSH Terms

Conditions

Low Back Pain; Obesity; Inflammation; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Pathologic Processes; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Marzena Ratajczak, PhD

  Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

• Małgorzata Waszak, PhD

  Poznan University of Physical Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 30, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)