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Completed

NCT Number: NCT02343432

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

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

Patients with acute discogenic pain were included in the study.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone

Drug

Triamcinolone

Other names: Kelanocort

Epidural Volume

Drug

Epidural Volume

Bupivacaine

Drug

Bupivacaine

Other names: Marcaine

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

Sponsors and collaborators

Lead sponsor

Neslihan Uztüre

Other

Collaborators

  • University of Gaziantep

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 22, 2015
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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