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Clinical Trials/NCT02343432
NCT02343432
Completed
Not Applicable

Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial

Neslihan Uztüre0 sites75 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Triamcinolone
Conditions
Pain
Sponsor
Neslihan Uztüre
Enrollment
75
Primary Endpoint
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This study was aimed to investigate the impact of using different epidural volumes.

Patients with acute discogenic pain were included in the study.

Detailed Description

Objectives: This study was aimed to investigate the impact of using different epidural volumes. Methods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone \[80 mg\] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) \[O= no pain, 10 = unbearable pain\], SLET(straight leg elevation test) \[0° = worst, 85° = best\], and Oswestry Disability Index; ODI \[0% to 20%:minimal disability , 80% to 100%:bed bound patients\] before and 2 weeks after the EPSI.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
September 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Neslihan Uztüre
Responsible Party
Sponsor Investigator
Principal Investigator

Neslihan Uztüre

assistant proffessor

Yeditepe University Hospital

Eligibility Criteria

Inclusion Criteria

  • acute discogenic pain with less than three months duration not responding to other modalities of conservative management \[NSAIDs, physiotherapy, bracing, etc.\],
  • radiological disc bulging accompanying unilateral root impingement symptoms,
  • an Oswestry daily activity score more than 20 percent, and
  • resistance to treatment.

Exclusion Criteria

  • Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.

Arms & Interventions

Epidural Volume 10mL

Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Triamcinolone

Epidural Volume 10mL

Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Epidural Volume

Epidural Volume 10mL

Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Bupivacaine

Epidural Volume 15mL

Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Triamcinolone

Epidural Volume 15mL

Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Epidural Volume

Epidural Volume 15mL

Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Bupivacaine

Epidural Volume 20mL

Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Triamcinolone

Epidural Volume 20mL

Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Epidural Volume

Epidural Volume 20mL

Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg

Intervention: Bupivacaine

Outcomes

Primary Outcomes

VAS (visual analog scale) [O= no pain, 10 = unbearable pain]

Time Frame: 2 weeks

Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]

Time Frame: 2 weeks

SLET(straight leg elevation test) [0° = worst, 85° = best]

Time Frame: 2 weeks

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