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

H

Hacettepe University

Status

Completed

Conditions

Low Back Pain

Treatments

Other: Conventional exercises
Other: Lumbal stabilization excercises

Study type

Interventional

Funder types

Other

Identifiers

NCT04912388
KA-20040

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

111 participants in 3 patient groups

The stabilization group
Experimental group
Description:
The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
Treatment:
Other: Lumbal stabilization excercises
The general exercise group
Experimental group
Description:
The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
Treatment:
Other: Conventional exercises
The control group
No Intervention group
Description:
Individuals in the control group will not be treated.

Trial contacts and locations

1

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Central trial contact

Birgül Morkoç, PhD student; Sevil Bilgin, assoc.prpf.

Data sourced from clinicaltrials.gov

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