CClinicalTrials.gg
Sign In
CompletedNCT02343432Updated Jan 22, 2015

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

An interventional study of Triamcinolone and Epidural Volume in Pain, sponsored by Neslihan Uztüre. Completed. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-22.

Sponsored by Neslihan Uztüre · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study summary

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

Patients with acute discogenic pain were included in the study.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • Anesthesia
  • Adverse Effect
  • Spinal
  • Epidural
03

In context

Lead sponsor

This is the only study on the registry with Neslihan Uztüre as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Epidural Volume 10mL

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

    Drug: Triamcinolone · Drug: Epidural Volume · Drug: Bupivacaine

  • Experimental
    Epidural Volume 15mL

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

    Drug: Triamcinolone · Drug: Epidural Volume · Drug: Bupivacaine

  • Experimental
    Epidural Volume 20mL

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

    Drug: Triamcinolone · Drug: Epidural Volume · Drug: Bupivacaine

Interventions

  • DrugTriamcinolone

    Triamcinolone

    Also known as: Kelanocort

  • DrugEpidural Volume

    Epidural Volume

  • DrugBupivacaine

    Bupivacaine

    Also known as: Marcaine

06

What researchers measure

Primary outcomes

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

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

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Runu R, Sinha NK, Pai R, Shankar PR, Vijayabhaskar P. Our experience with epidural steroid injections in management of low backpain and sciatica. Kathmandu Univ Med J (KUMJ). 2005 Oct-Dec;3(4):349-54. PubMed 16449834 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02343432
Lead sponsor
Neslihan Uztüre
Collaborators
University of Gaziantep
Responsible party
Neslihan Uztüre (assistant proffessor, Yeditepe University Hospital) — Sponsor-investigator
First posted
Jan 22, 2015
Start date
Mar 2008
Primary completion
Aug 2008
Completion
Sep 2008
Last update
Jan 22, 2015

Study contacts

Lütfiye Budak
study director · University of Gaziantep

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion