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Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?

Not Applicable
Completed
Conditions
Pain
Interventions
Registration Number
NCT02343432
Lead Sponsor
Neslihan Uztüre
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Epidural Volume 15mLEpidural VolumeEpidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 20mLBupivacaineEpidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 10mLTriamcinoloneEpidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 15mLBupivacaineEpidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 20mLEpidural VolumeEpidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 10mLEpidural VolumeEpidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 10mLBupivacaineEpidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 15mLTriamcinoloneEpidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 20mLTriamcinoloneEpidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
Primary Outcome Measures
NameTimeMethod
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]2 weeks
Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]2 weeks
SLET(straight leg elevation test) [0° = worst, 85° = best]2 weeks
Secondary Outcome Measures
NameTimeMethod
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