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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343432
• Other study ID #: 03-2008/23
• Status: Completed
• Phase: N/A
• First received: November 8, 2014
• Last updated: January 15, 2015
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2015
• Source: Yeditepe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Patients with acute discogenic pain were included in the study.

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Triamcinolone
Triamcinolone
• Epidural Volume
Epidural Volume
• Bupivacaine
Bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Neslihan Uztüre	University of Gaziantep

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS (visual analog scale) [O= no pain, 10 = unbearable pain]		2 weeks
Primary	SLET(straight leg elevation test) [0° = worst, 85° = best]		2 weeks
Primary	Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]		2 weeks