Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Mar 2008
Shorter than P25 for not_applicable pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedJanuary 22, 2015
January 1, 2015
5 months
November 8, 2014
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
2 weeks
SLET(straight leg elevation test) [0° = worst, 85° = best]
2 weeks
Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]
2 weeks
Study Arms (3)
Epidural Volume 10mL
EXPERIMENTALEpidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 15mL
EXPERIMENTALEpidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
Epidural Volume 20mL
EXPERIMENTALEpidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
Interventions
Triamcinolone
Bupivacaine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neslihan Uztürelead
- University of Gaziantepcollaborator
Related Publications (1)
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.
PMID: 16449834BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lütfiye Budak
University of Gaziantep
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant proffessor
Study Record Dates
First Submitted
November 8, 2014
First Posted
January 22, 2015
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
January 22, 2015
Record last verified: 2015-01