The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection
|ClinicalTrials.gov Identifier: NCT03821350|
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Radiculopathy||Other: Information leaflet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel group|
|Masking Description:||The study was designed as prospective, single blinded, randomized controlled study. Patients were randomized into two groups. The enrollment of the participants was carried out by an independent researcher. Pre and post-injection evaluation was performed by the investigators who had no knowledge about the groups|
|Official Title:||The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection|
|Actual Study Start Date :||December 30, 2013|
|Actual Primary Completion Date :||December 30, 2014|
|Actual Study Completion Date :||December 25, 2015|
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.
- Numeric rating scale [ Time Frame: 3 months ]The patient is asked to give a score between 1 and 10 to explain the pain level.
- Oswestry disability index [ Time Frame: 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.
- Hospital Anxiety and Depression Scale [ Time Frame: 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.
- Somatosensory Amplification Scale [ Time Frame: 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.