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

NCT ID: NCT03821350

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-30
• Study Completion Date: 2015-12-25

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.

Conditions

Low Back Pain; Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

The control group was given verbal information

Group Type: NO_INTERVENTION

No interventions assigned to this group

Leaflet Group

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

Group Type: EXPERIMENTAL

Information leaflet

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hitit University

OTHER

Sponsor Role: lead

Responsible Party

Yeliz Bahar Ozdemir

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 12537268 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26689476 (View on PubMed)

Other Identifiers

09.2014.0089

Identifier Type: -

Identifier Source: org_study_id