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

Not Applicable

Completed

• Conditions: Low Back Pain; Radiculopathy
• Interventions: Other: Information leaflet

• Registration Number: NCT03821350
• Lead Sponsor: Hitit University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-12-30
• Primary Completion: 2014-12-30
• Study Completion: 2015-12-25
• Status Verified: 2019-01
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-28
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-29
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leaflet Group	Information leaflet	The second group was given verbal information and a detailed information leaflet with written and visual content

Primary Outcome Measures

Name	Time	Method
Oswestry disability index	3 months	The oswestry disability index is a survey designed to investigate how lumbar and leg pain affects their daily lives. It consists of 10 questions investigating the general life activity of the patient. The patient receives at least 0 points and at most 5 points from each question. The higher scores indicate that increased disability.
Numeric rating scale	3 months	The patient is asked to give a score between 1 and 10 to explain the pain level.

Secondary Outcome Measures

Name	Time	Method
Somatosensory Amplification Scale	3 months	The Somatosensory Amplification Scale is a scale consisting of 10 items. The items include a series of disturbing bodily sensations that do not present a disease.
Hospital Anxiety and Depression Scale	3 months	The Hospital Anxiety and Depression Scale is an easy-to-use questionnaire consisting of 14 questions that examines the symptoms of depression with 7 questions and anxiety with 7 questions.