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Completed

NCT Number: NCT03821350

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

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.

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Key information

Conditions

Low Back Pain Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

information leaflet

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 29, 2019
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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