Back to resultsSerum Cytokine Levels in Patients With Lumbal Disc Herniation and Effectiveness of Exercise
Primary Purpose
Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lumbal stabilization excercises
Conventional exercises
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Disc herniation, Stabilization exercises, General exercises, Cytokines, Inflammation
Eligibility Criteria
Inclusion Criteria for patients with disc herniation:
- Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
- not an indication for lumbar disc herniation surgery
- for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
- pain intensity of VAS ≥ 3
- male and female patients between the ages of 20-55
Inclusion Criteria for heathy people
- not having low back pain complaints in the past
- female and male healthy individuals between the ages of 20-55
Exclusion Criteria:
- systemic or inflammatory disease
- pregnant or breastfeeding women
- surgery of lumbar region
- fracture of lumbar vertebrae
- lumbar scoliosis
- medication use for psychiatric disorders
- tumor
- allergy
- neurological disease
- alcohol-drug use
- generalized musculoskeletal pain
Sites / Locations
- Faculty of Physiotherapy and rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
The stabilization group
The general exercise group
The control group
Arm Description
The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
Individuals in the control group will not be treated.
Outcomes
Primary Outcome Measures
inflammatory cytokines
Tnf-alfa , IL-6, IL-4, IL-1β, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912388
Brief Title
Serum Cytokine Levels in Patients With Lumbal Disc Herniation and Effectiveness of Exercise
Official Title
Serum Cytokine Levels in Patients With Lumbal Disc Herniation With and Without Neurological Deficits and Effectiveness of Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2021 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study.
Detailed Description
The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Disc herniation, Stabilization exercises, General exercises, Cytokines, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The stabilization group
Arm Type
Experimental
Arm Description
The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
Arm Title
The general exercise group
Arm Type
Experimental
Arm Description
The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Individuals in the control group will not be treated.
Intervention Type
Other
Intervention Name(s)
Lumbal stabilization excercises
Intervention Description
The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
Intervention Type
Other
Intervention Name(s)
Conventional exercises
Intervention Description
The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
Primary Outcome Measure Information:
Title
inflammatory cytokines
Description
Tnf-alfa , IL-6, IL-4, IL-1β, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients with disc herniation:
Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
not an indication for lumbar disc herniation surgery
for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
pain intensity of VAS ≥ 3
male and female patients between the ages of 20-55
Inclusion Criteria for heathy people
not having low back pain complaints in the past
female and male healthy individuals between the ages of 20-55
Exclusion Criteria:
systemic or inflammatory disease
pregnant or breastfeeding women
surgery of lumbar region
fracture of lumbar vertebrae
lumbar scoliosis
medication use for psychiatric disorders
tumor
allergy
neurological disease
alcohol-drug use
generalized musculoskeletal pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevil Bilgin, assoc.prpf.
Phone
+905302431684
Email
sevilcuvalci@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Birgül Morkoç, PhD student
Email
birgul.morkoc@hacettepe.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgül Morkoç, PhD student
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy and rehabilitation
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06030
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sevil Bilgin, Assoc.Prof.
Phone
+905302431684
Email
sevilcuvalci@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Non are planned to be shared
Learn more about this trial
Serum Cytokine Levels in Patients With Lumbal Disc Herniation and Effectiveness of Exercise
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