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

NCT03821350 | Completed

• 1 other identifier: 09.2014.0089
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Radiculopathy

Keywords

Transforaminal epidural steroid injection; Radicular pain

Outcome Measures

Primary Outcomes (2)

• Numeric rating scale

  The patient is asked to give a score between 1 and 10 to explain the pain level.

  3 months

• 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.

  3 months

Secondary Outcomes (2)

• Hospital Anxiety and Depression Scale

  3 months

• Somatosensory Amplification Scale

  3 months

Study Arms (2)

Control Group

NO INTERVENTION

The control group was given verbal information

Leaflet Group

EXPERIMENTAL

The second group was given verbal information and a detailed information leaflet with written and visual content

Other: Information leaflet

Interventions

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.

Leaflet Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hitit University: lead

Related Publications (2)

• 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.

  PMID: 12537268 BACKGROUND

• 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.

  PMID: 26689476 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel group

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: December 30, 2013
• Primary Completion: December 30, 2014
• Study Completion: December 25, 2015
• Last Updated: January 29, 2019

Record last verified: 2019-01