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

NCT04912388 | Completed

• 1 other identifier: KA-20040
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; Disc herniation; Stabilization exercises; General exercises; Cytokines; Inflammation

Outcome Measures

Primary Outcomes (1)

• inflammatory cytokines

  Tnf-alfa , IL-6, IL-4, IL-1β, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.

  6 weeks

Study Arms (3)

The stabilization group

EXPERIMENTAL

The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.

Other: Lumbal stabilization excercises

The general exercise group

EXPERIMENTAL

The general exercise group will perform conventional exercises 3 times a week during 6 weeks.

Other: Conventional exercises

The control group

NO INTERVENTION

Individuals in the control group will not be treated.

Interventions

Lumbal stabilization excercises OTHER

The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.

The stabilization group

Conventional exercises OTHER

The general exercise group will perform conventional exercises 3 times a week during 6 weeks.

The general exercise group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• not having low back pain complaints in the past
• female and male healthy individuals between the ages of 20-55

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Faculty of Physiotherapy and rehabilitation

Ankara, Altındağ, 06030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement; Inflammation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathologic Processes

Study Officials

• Birgül Morkoç, PhD student

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: July 30, 2021
• Primary Completion: February 23, 2024
• Study Completion: July 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)