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

NCT ID: NCT02343432

Last Updated: 2015-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Epidural Volume 10mL

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Triamcinolone

Epidural Volume

Intervention Type DRUG

Epidural Volume

Bupivacaine

Intervention Type DRUG

Bupivacaine

Epidural Volume 15mL

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Triamcinolone

Epidural Volume

Intervention Type DRUG

Epidural Volume

Bupivacaine

Intervention Type DRUG

Bupivacaine

Epidural Volume 20mL

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Triamcinolone

Epidural Volume

Intervention Type DRUG

Epidural Volume

Bupivacaine

Intervention Type DRUG

Bupivacaine

Interventions

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Triamcinolone

Triamcinolone

Intervention Type DRUG

Epidural Volume

Epidural Volume

Intervention Type DRUG

Bupivacaine

Bupivacaine

Intervention Type DRUG

Other Intervention Names

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Kelanocort Marcaine

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Gaziantep

OTHER

Sponsor Role collaborator

Neslihan Uztüre

OTHER

Sponsor Role lead

Responsible Party

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Neslihan Uztüre

assistant proffessor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lütfiye Budak

Role: STUDY_DIRECTOR

University of Gaziantep

References

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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.

Reference Type BACKGROUND
PMID: 16449834 (View on PubMed)

Other Identifiers

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03-2008/23

Identifier Type: -

Identifier Source: org_study_id

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