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The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection

H

Hitit University

Status

Completed

Conditions

Radiculopathy
Low Back Pain

Treatments

Other: Information leaflet

Study type

Interventional

Funder types

Other

Identifiers

NCT03821350
09.2014.0089

Details and patient eligibility

About

Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation in recent years.

The assessment of comorbid psychiatric conditions such as depression, anxiety, and somatization disorder and given the detailed and visual information to patients who will be undergone TFESI could affect the result of the treatment in a good way. The pain questionnaire used for objectively evaluating injection outcomes is personality dependent and there are many factors that can affect it.

Full description

Although information leaflets given to patients prior to surgical or non-surgical interventions have not yet been used as a standard in each clinic, the effects on patients have been frequently researched in recently. A detailed description of the treatment, the devices to be used and the disclosure of the steps of the procedure may have an effect on the result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect of the written and visual informative form given before the injection of the lumbosacral TFESI.

Enrollment

166 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • lumbar radiculopathy due to lumbar disc herniation,
  • unresponsive to conservative treatments,
  • duration of pain is less than 3 months,
  • patients scheduled for the first time with TFESI.

Exclusion criteria

  • the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...),
  • underwent epidural injection in the last 6 months,
  • to have a history of lumbar spinal surgery,
  • inflammatory diseases (rheumatoid arthritis, spondyloarthropathy),
  • spinal infection or malignancy,
  • to benefit from six-week medical treatment,
  • be reluctant to participate in the work and follow up,
  • who are illiterate,
  • the patients with psychiatric disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

166 participants in 2 patient groups

Control Group
No Intervention group
Description:
The control group was given verbal information
Leaflet Group
Experimental group
Description:
The second group was given verbal information and a detailed information leaflet with written and visual content
Treatment:
Other: Information leaflet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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