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

The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Radiculopathy
• Intervention / Treatment: Other: Information leaflet

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 Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group was given verbal information
Experimental: Leaflet Group; The second group was given verbal information and a detailed information leaflet with written and visual content	Other: Information leaflet; The written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale	The patient is asked to give a score between 1 and 10 to explain the pain level.	3 months
Oswestry disability index	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	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.	3 months
Somatosensory Amplification Scale	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.	3 months

Collaborators and Investigators

• Sponsor: Hitit University

Publications and helpful links

General Publications

• Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, Devin CJ. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology. Spine J. 2016 Aug;16(8):928-34. doi: 10.1016/j.spinee.2015.11.058. Epub 2015 Dec 9.
• Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2013
• Primary Completion (Actual): December 30, 2014
• Study Completion (Actual): December 25, 2015

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Radicular pain; Transforaminal epidural steroid injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Radiculopathy
• Other Study ID Numbers: 09.2014.0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No