Clinical trial NCT04507074: The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Obesity
Keywords: biomarkers of low back pain
inflammation
disk degeneration
traction therapy
lumbar traction
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 49
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
timeFrame: pre-intervention
measure: Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
timeFrame: 48 hours after the intervention
measure: Stem cell growth factor β [ng/ml]
timeFrame: pre-intervention
measure: Stem cell growth factor β [ng/ml]
timeFrame: 48 hours after the intervention
measure: Leptin [ng/ml]
timeFrame: pre-intervention
measure: Leptin [ng/ml]
timeFrame: 48 hours after the intervention
measure: Adipsin [pg/ml]
timeFrame: pre-intervention
measure: Adipsin [pg/ml]
timeFrame: 48 hours after the intervention
measure: Neuropeptide Y [pg/ml]
timeFrame: pre-intervention
measure: Neuropeptide Y [pg/ml]
timeFrame: 48 hours after the intervention
measure: Vascular Endothelial Growth Factor [pg/ml]
timeFrame: pre-intervention
measure: Vascular Endothelial Growth Factor [pg/ml]
timeFrame: 48 hours after the intervention
measure: Chondroitin sulfate CS846 [ng/mL]
timeFrame: pre-intervention
measure: Chondroitin sulfate CS846 [ng/mL]
timeFrame: 48 hours after the intervention
Secondary outcomes:
measure: Magnetic resonance imaging of the lumbosacral spine
timeFrame: pre-intervention
measure: Total body fat content [%]
timeFrame: pre-intervention
measure: Total body fat content [%]
timeFrame: 48 hours after the intervention
measure: Lean body mass [kg]
timeFrame: pre-intervention
measure: Lean body mass [kg]
timeFrame: 48 hours after the intervention
measure: Mobility of the spine
timeFrame: pre-intervention
measure: Mobility of the spine
timeFrame: 48 hours after the intervention
measure: Muscle bioelectric signal amplitude
timeFrame: pre-intervention
measure: Muscle bioelectric signal amplitude
timeFrame: 48 hours after the intervention
measure: State of tension of erector spinae muscles [Hz]
timeFrame: pre-intervention
measure: Dynamic stiffness of erector spinae muscles [N/m]
timeFrame: pre-intervention
measure: Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
timeFrame: pre-intervention
measure: State of tension of erector spinae muscles [Hz]
timeFrame: 48 hours after the intervention
measure: Dynamic stiffness of erector spinae muscles [N/m]
timeFrame: 48 hours after the intervention
measure: Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
timeFrame: 48 hours after the intervention
measure: Pain threshold
timeFrame: pre-intervention
measure: Pain threshold
timeFrame: 48 hours after the intervention
measure: Pain intensity: questionnaire
timeFrame: pre-intervention
measure: Pain intensity: questionnaire
timeFrame: 48 hours after the intervention
measure: Disability caused by pain in the spine
timeFrame: pre-intervention
measure: Disability caused by pain in the spine
timeFrame: 48 hours after the intervention
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Physical Education
Study officials:
affiliation: Poznan University of Physical Education
name: Marzena Ratajczak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan University of Physical Education
name: Małgorzata Waszak, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.