PainNCT02343432
Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?
A study testing Triamcinolone, Epidural Volume and Bupivacaine in people with Pain, run by Neslihan Uztüre.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Triamcinolone, Epidural Volume and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial
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.
- Conditions
- Pain
- Being tested
- Triamcinolone, Epidural Volume, Bupivacaine
- Keywords
- Anesthesia, Adverse Effect, Spinal, Epidural
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Also called Kelanocort
Triamcinolone
Epidural VolumeDrug
Epidural Volume
BupivacaineDrug
Also called Marcaine
Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Epidural Volume 10mL | Experimental | Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg Receives: Drug: Triamcinolone; Drug: Epidural Volume; Drug: Bupivacaine |
| Epidural Volume 15mL | Experimental | Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg Receives: Drug: Triamcinolone; Drug: Epidural Volume; Drug: Bupivacaine |
| Epidural Volume 20mL | Experimental | Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg Receives: Drug: Triamcinolone; Drug: Epidural Volume; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
Measured: 2 weeks
SLET(straight leg elevation test) [0° = worst, 85° = best]
Measured: 2 weeks
Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Uztüre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gaziantep
- Responsible party
- Sponsor-investigator, Neslihan Uztüre, Yeditepe University Hospital
- Investigators
- Lütfiye Budak, Study director, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343432
- Sponsor's protocol ID
- 03-2008/23
- Status last verified
- Jan 2015
- First submitted
- 8 Nov 2014
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial
- ClinicalTrials.gov ID
- NCT02343432
- Acronym / sponsor ID
- 03-2008/23
- Conditions
- Pain
- Keywords
- Anesthesia, Adverse Effect, Spinal, Epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Neslihan UztüreUniversity, hospital or other
- Collaborators
- University of Gaziantep
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural Volume 10mL | Experimental | Drug: Triamcinolone, Drug: Epidural Volume, Drug: BupivacaineEpidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg |
| Epidural Volume 15mL | Experimental | Drug: Triamcinolone, Drug: Epidural Volume, Drug: BupivacaineEpidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg |
| Epidural Volume 20mL | Experimental | Drug: Triamcinolone, Drug: Epidural Volume, Drug: BupivacaineEpidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriamcinoloneAlso: KelanocortTriamcinolone | Drug | Epidural Volume 10mL, Epidural Volume 15mL, Epidural Volume 20mL |
| Epidural VolumeEpidural Volume | Drug | Epidural Volume 10mL, Epidural Volume 15mL, Epidural Volume 20mL |
| BupivacaineAlso: MarcaineBupivacaine | Drug | Epidural Volume 10mL, Epidural Volume 15mL, Epidural Volume 20mL |
Primary outcome
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
Time frame: 2 weeks
SLET(straight leg elevation test) [0° = worst, 85° = best]
Time frame: 2 weeks
Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Background: PubMed 16449834Runu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lütfiye Budak study director
University of Gaziantep
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone, Epidural Volume and Bupivacaine in people with Pain, run by Neslihan Uztüre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (visual analog scale) [O= no pain, 10 = unbearable pain] (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02343432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.