Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04507074
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2020-07-06
Brief Title:
The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
Sponsor:
Poznan University of Physical Education
Organization:
Poznan University of Physical Education
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15T 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 patients 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
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 15T 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None