Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821350
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yeliz Bahar Ozdemir, Hitit University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Low Back Pain Radiculopathy Other: Information leaflet Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group
Masking: Single (Investigator)
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
Primary Purpose: Treatment
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Numeric rating scale [ Time Frame: 3 months ]
    The patient is asked to give a score between 1 and 10 to explain the pain level.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Yeliz Bahar Ozdemir, Principal Investigator, Hitit University
ClinicalTrials.gov Identifier: NCT03821350    
Other Study ID Numbers: 09.2014.0089
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeliz Bahar Ozdemir, Hitit University:
Transforaminal epidural steroid injection
Radicular pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
 Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases