Serum Cytokine Levels in Patients With Lumbal Disc Herniation and Effectiveness of Exercise

Low Back Pain Clinical Trial

Official title:

Serum Cytokine Levels in Patients With Lumbal Disc Herniation With and Without Neurological Deficits and Effectiveness of Exercise

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04912388
• Other study ID #: KA-20040
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: July 30, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Hernia
• Intervertebral Disc Displacement
• Low Back Pain

Intervention

Other:
• Lumbal stabilization excercises
The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
• Conventional exercises
The general exercise group will perform conventional exercises 3 times a week during 6 weeks.

Locations

Country	Name	City	State
Turkey	Faculty of Physiotherapy and rehabilitation	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory cytokines	Tnf-alfa , IL-6, IL-4, IL-1ß, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.	6 weeks