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Completed

NCT Number: NCT04912388

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy and rehabilitation

Ankara, Altındağ, 06030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

conventional exercises

Other

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

Primary outcomes

  1. inflammatory cytokines

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2021
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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