Status:
COMPLETED
The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain
Lead Sponsor:
Poznan University of Physical Education
Conditions:
Low Back Pain
Obesity
Eligibility:
All Genders
35-60 years
Phase:
NA
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 in...
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 toget...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04507074
Start Date
September 1 2020
End Date
December 30 2024
Last Update
September 23 2025
Active Locations (1)
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1
Poznan University of Physical Education
Poznan, Poland, 61-871