Low Back PainNCT04507074
The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
A study testing lumbar traction therapy in people with Low Back Pain and Obesity, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Low Back Pain, Obesity
- What is being tested?
- lumbar traction therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2020to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 22Show fewer
- 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);
- Acute or chronic, clinically apparent inflammatory process of the respiratory tract, inflammatory processes of the genitourinary system, inflammatory process in the head and neck;
- Acute infection in the last month;
- Cancer;
- Alcohol abuse, drug addiction;
- Pregnancy;
- Uncontrolled mental illness that may falsify test results;
- Other conditions which may pose any risk to the patient during the observation.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Low Back Pain, Obesity
- Being tested
- lumbar traction therapy
- Keywords
- biomarkers of low back pain, inflammation, disk degeneration, traction therapy, lumbar traction
- Medical subject headings
- Low Back Pain, Obesity, Inflammation, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar traction therapyDevice
Also called lumbar traction
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients With Obesity | Experimental | 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain. Receives: 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. Receives: Device: lumbar traction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
ELISA
Measured: pre-intervention
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
ELISA
Measured: 48 hours after the intervention
Stem cell growth factor β [ng/ml]
ELISA
Measured: pre-intervention
Stem cell growth factor β [ng/ml]
ELISA
Measured: 48 hours after the intervention
Leptin [ng/ml]
ELISA
Measured: pre-intervention
Leptin [ng/ml]
ELISA
Measured: 48 hours after the intervention
Adipsin [pg/ml]
ELISA
Measured: pre-intervention
Adipsin [pg/ml]
ELISA
Measured: 48 hours after the intervention
Neuropeptide Y [pg/ml]
ELISA
Measured: pre-intervention
Neuropeptide Y [pg/ml]
ELISA
Measured: 48 hours after the intervention
Vascular Endothelial Growth Factor [pg/ml]
ELISA
Measured: pre-intervention
Vascular Endothelial Growth Factor [pg/ml]
ELISA
Measured: 48 hours after the intervention
Chondroitin sulfate CS846 [ng/mL]
ELISA
Measured: pre-intervention
Chondroitin sulfate CS846 [ng/mL]
ELISA
Measured: 48 hours after the intervention
Secondary outcomes (21)
Magnetic resonance imaging of the lumbosacral spine
MRI 1.5T
Measured: pre-intervention
Total body fat content [%]
dual energy X-ray absorptiometry (DXA)
Measured: pre-intervention
Total body fat content [%]
dual energy X-ray absorptiometry (DXA)
Measured: 48 hours after the intervention
Lean body mass [kg]
dual energy X-ray absorptiometry (DXA)
Measured: pre-intervention
Lean body mass [kg]
dual energy X-ray absorptiometry (DXA)
Measured: 48 hours after the intervention
Mobility of the spine
electrogoniometer
Measured: pre-intervention
Mobility of the spine
electrogoniometer
Measured: 48 hours after the intervention
Muscle bioelectric signal amplitude
electromyograph
Measured: pre-intervention
Muscle bioelectric signal amplitude
electromyograph
Measured: 48 hours after the intervention
State of tension of erector spinae muscles [Hz]
Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.
Measured: pre-intervention
Dynamic stiffness of erector spinae muscles [N/m]
Biomechanical properties will be assessed with myotonometer device.
Measured: pre-intervention
Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
Biomechanical properties will be assessed with myotonometer device.
Measured: pre-intervention
State of tension of erector spinae muscles [Hz]
Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.
Measured: 48 hours after the intervention
Dynamic stiffness of erector spinae muscles [N/m]
Biomechanical properties will be assessed with myotonometer device.
Measured: 48 hours after the intervention
Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
Biomechanical properties will be assessed with myotonometer device.
Measured: 48 hours after the intervention
Pain threshold
algometer
Measured: pre-intervention
Pain threshold
algometer
Measured: 48 hours after the intervention
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
Measured: pre-intervention
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
Measured: 48 hours after the intervention
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.
Measured: pre-intervention
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.
Measured: 48 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2022
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marzena Ratajczak, Poznan University of Physical Education
- Investigators
- Marzena Ratajczak, PhD, Principal investigator, Poznan University of Physical EducationMałgorzata Waszak, PhD, Study chair, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507074
- Sponsor's protocol ID
- PoznanUPhyEd no. 3
- Status last verified
- Sep 2025
- First submitted
- 6 Jul 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28347933Omarker 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 9839819Maciaszek 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 26440592Tarabeih 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 30776685Sowa 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 25367206Ratajczak 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 42367161Ratajczak 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04507074
- Acronym / sponsor ID
- PoznanUPhyEd no. 3
- Conditions
- Low Back Pain, Obesity
- Keywords
- biomarkers of low back pain, inflammation, disk degeneration, traction therapy, lumbar traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Obesity | Experimental | Device: lumbar traction therapy40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain. |
| Normal-Weight Patients | Active comparator | Device: lumbar traction therapy20 subjects aged 35-60 with normal body weight (BMI ≤ 24.9 and ≥ 18.5 kg/m2) suffering from chronic low back pain. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar traction therapyAlso: lumbar tractionThe 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). | Device | Normal-Weight Patients, Patients With Obesity |
Primary outcome
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
Time frame: pre-intervention
ELISA
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
Time frame: 48 hours after the intervention
ELISA
Stem cell growth factor β [ng/ml]
Time frame: pre-intervention
ELISA
Stem cell growth factor β [ng/ml]
Time frame: 48 hours after the intervention
ELISA
Leptin [ng/ml]
Time frame: pre-intervention
ELISA
Leptin [ng/ml]
Time frame: 48 hours after the intervention
ELISA
Adipsin [pg/ml]
Time frame: pre-intervention
ELISA
Adipsin [pg/ml]
Time frame: 48 hours after the intervention
ELISA
Neuropeptide Y [pg/ml]
Time frame: pre-intervention
ELISA
Neuropeptide Y [pg/ml]
Time frame: 48 hours after the intervention
ELISA
Vascular Endothelial Growth Factor [pg/ml]
Time frame: pre-intervention
ELISA
Vascular Endothelial Growth Factor [pg/ml]
Time frame: 48 hours after the intervention
ELISA
Chondroitin sulfate CS846 [ng/mL]
Time frame: pre-intervention
ELISA
Chondroitin sulfate CS846 [ng/mL]
Time frame: 48 hours after the intervention
ELISA
21 secondary outcomes
Magnetic resonance imaging of the lumbosacral spine
Time frame: pre-intervention
Total body fat content [%]
Time frame: pre-intervention
Total body fat content [%]
Time frame: 48 hours after the intervention
Lean body mass [kg]
Time frame: pre-intervention
Lean body mass [kg]
Time frame: 48 hours after the intervention
Mobility of the spine
Time frame: pre-intervention
Mobility of the spine
Time frame: 48 hours after the intervention
Muscle bioelectric signal amplitude
Time frame: pre-intervention
Muscle bioelectric signal amplitude
Time frame: 48 hours after the intervention
State of tension of erector spinae muscles [Hz]
Time frame: pre-intervention
Dynamic stiffness of erector spinae muscles [N/m]
Time frame: pre-intervention
Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
Time frame: pre-intervention
State of tension of erector spinae muscles [Hz]
Time frame: 48 hours after the intervention
Dynamic stiffness of erector spinae muscles [N/m]
Time frame: 48 hours after the intervention
Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
Time frame: 48 hours after the intervention
Pain threshold
Time frame: pre-intervention
Pain threshold
Time frame: 48 hours after the intervention
Pain intensity: questionnaire
Time frame: pre-intervention
Pain intensity: questionnaire
Time frame: 48 hours after the intervention
Disability caused by pain in the spine
Time frame: pre-intervention
Disability caused by pain in the spine
Time frame: 48 hours after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 28347933Chow 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.
- Background: PubMed 9839819Omarker 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.
- BackgroundMaciaszek 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: PubMed 26440592Weber 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.
- Background: PubMed 30776685Tarabeih 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.
- Background: PubMed 25367206Sowa 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.
- Derived from this study: PubMed 42367161Ratajczak 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.
- Derived from this study: PubMed 36927409Ratajczak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzena Ratajczak, PhD principal investigator
Poznan University of Physical Education
Małgorzata Waszak, PhD study chair
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar traction therapy in people with Low Back Pain and Obesity, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml] (time frame: pre-intervention). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507074, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.