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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821350
• Other study ID #: 09.2014.0089
• Status: Completed
• Phase: N/A
• Start date: December 30, 2013
• Est. completion date: December 25, 2015

Study information

• Verified date: January 2019
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 25, 2015
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

References & Publications (2)

Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drapé JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale	The patient is asked to give a score between 1 and 10 to explain the pain level.	3 months
Primary	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	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
Secondary	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