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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
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Transforaminal epidural steroid injection, Radicular pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 25, 2019
    Last Updated
    January 28, 2019
    Sponsor
    Hitit University
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    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

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

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