Clinical trial NCT03821350: The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection
Official title: The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Radiculopathy
Keywords: Transforaminal epidural steroid injection
Radicular pain
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric rating scale
timeFrame: 3 months
measure: Oswestry disability index
timeFrame: 3 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 months
measure: Somatosensory Amplification Scale
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.