The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection
Primary Purpose
Low Back Pain, Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Information leaflet
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Transforaminal epidural steroid injection, Radicular pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Leaflet Group
Arm Description
The control group was given verbal information
The second group was given verbal information and a detailed information leaflet with written and visual content
Outcomes
Primary Outcome Measures
Numeric rating scale
The patient is asked to give a score between 1 and 10 to explain the pain level.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03821350
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 30, 2013 (Actual)
Primary Completion Date
December 30, 2014 (Actual)
Study Completion Date
December 25, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Radiculopathy
Keywords
Transforaminal epidural steroid injection, Radicular pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group
Masking
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
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group was given verbal information
Arm Title
Leaflet Group
Arm Type
Experimental
Arm Description
The second group was given verbal information and a detailed information leaflet with written and visual content
Intervention Type
Other
Intervention Name(s)
Information leaflet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric rating scale
Description
The patient is asked to give a score between 1 and 10 to explain the pain level.
Time Frame
3 months
Title
Oswestry disability index
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
3 months
Title
Somatosensory Amplification Scale
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12537268
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.
Results Reference
background
PubMed Identifier
26689476
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.
Results Reference
background
Learn more about this trial
The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection
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