Spinal StenosisNCT02939482
A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection
A study testing Triamcinolone Acetonide and normal saline solution in people with Spinal Stenosis and Lumbosacral Spondylosis, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Stenosis, Lumbosacral Spondylosis, Radiculopathy
- What is being tested?
- Triamcinolone Acetonide and normal saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2016to 30 Jan 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lumbosacral spinal stenosis with radiculopathy
- no improvement after conservative treatment for 6 weeks
Who cannot join
- previous CESI or spinal surgery
- skin infection at injection site
- uncontrolled diabetes mellitus
- abnormal coagulogram
- vertebral fracture
- previous history of allergy to steroid or anesthetic agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.
- Conditions
- Spinal Stenosis, Lumbosacral Spondylosis, Radiculopathy
- Being tested
- Triamcinolone Acetonide and normal saline solution
- Medical subject headings
- Spinal Stenosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide and normal saline solutionDrug
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 40 ml/min | Active comparator | Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min Receives: Drug: Triamcinolone Acetonide and normal saline solution |
| Group 2: 20 ml/min | Experimental | Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min Receives: Drug: Triamcinolone Acetonide and normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
Measured: 2, 6, 12 weeks
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
Measured: 2, 6, 12 weeks
Change from baseline Standing tolerance test at 2, 6, 12 weeks
Measured: 2, 6, 12 weeks
Change from baseline Walking tolerance test at 2, 6, 12 weeks
Measured: 2, 6, 12 weeks
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks
Measured: 2, 6, 12 weeks
Secondary outcomes (1)
Complication of Caudal Epidural Steroid Injection
Measured: 2, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion2 Aug 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satit Thiengwittayaporn, Navamindradhiraj University
- Investigators
- Satit Thiengwittayaporn, M.D., Principal investigator, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939482
- Sponsor's protocol ID
- COA 74/2559
- Status last verified
- Jun 2019
- First submitted
- 15 Oct 2016
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Watts RW, Silagy CA. A meta-analysis on the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesth Intensive Care. 1995 Oct;23(5):564-9. doi: 10.1177/0310057X9502300506.
PubMed 8787255Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Sanelli JT, Freeman ED, Slaten WK, Rao S. Fluoroscopically guided lumbar transformational epidural steroid injections in degenerative lumbar stenosis: an outcome study. Am J Phys Med Rehabil. 2002 Dec;81(12):898-905. doi: 10.1097/00002060-200212000-00003.
PubMed 12447088Kraiwattanapong C, Wechmongkolgorn S, Chatriyanuyok B, Woratanarat P, Udomsubpayakul U, Chanplakorn P, Keorochana G, Wajanavisit W. Outcomes of fluoroscopically guided lumbar transforaminal epidural steroid injections in degenerative lumbar spondylolisthesis patients. Asian Spine J. 2014 Apr;8(2):119-28. doi: 10.4184/asj.2014.8.2.119. Epub 2014 Apr 8.
PubMed 24761192
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT02939482
- Acronym / sponsor ID
- COA 74/2559
- Conditions
- Spinal Stenosis, Lumbosacral Spondylosis, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 20 Oct 2016 (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.
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 40 ml/min | Active comparator | Drug: Triamcinolone Acetonide and normal saline solutionTriamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min |
| Group 2: 20 ml/min | Experimental | Drug: Triamcinolone Acetonide and normal saline solutionTriamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- lumbosacral spinal stenosis with radiculopathy
- no improvement after conservative treatment for 6 weeks
Key exclusion criteria (6 listed)
- previous CESI or spinal surgery
- skin infection at injection site
- uncontrolled diabetes mellitus
- abnormal coagulogram
- vertebral fracture
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 |
|---|---|---|
| Triamcinolone Acetonide and normal saline solution80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution | Drug | Group 1: 40 ml/min, Group 2: 20 ml/min |
Primary outcome
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
Time frame: 2, 6, 12 weeks
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
Time frame: 2, 6, 12 weeks
Change from baseline Standing tolerance test at 2, 6, 12 weeks
Time frame: 2, 6, 12 weeks
Change from baseline Walking tolerance test at 2, 6, 12 weeks
Time frame: 2, 6, 12 weeks
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks
Time frame: 2, 6, 12 weeks
1 secondary outcome
Complication of Caudal Epidural Steroid Injection
Time frame: 2, 6, 12 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 25 Jun 2019.
- Results publication: PubMed 8787255Watts RW, Silagy CA. A meta-analysis on the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesth Intensive Care. 1995 Oct;23(5):564-9. doi: 10.1177/0310057X9502300506.
- Results publication: PubMed 12447088Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Sanelli JT, Freeman ED, Slaten WK, Rao S. Fluoroscopically guided lumbar transformational epidural steroid injections in degenerative lumbar stenosis: an outcome study. Am J Phys Med Rehabil. 2002 Dec;81(12):898-905. doi: 10.1097/00002060-200212000-00003.
- Results publication: PubMed 24761192Kraiwattanapong C, Wechmongkolgorn S, Chatriyanuyok B, Woratanarat P, Udomsubpayakul U, Chanplakorn P, Keorochana G, Wajanavisit W. Outcomes of fluoroscopically guided lumbar transforaminal epidural steroid injections in degenerative lumbar spondylolisthesis patients. Asian Spine J. 2014 Apr;8(2):119-28. doi: 10.4184/asj.2014.8.2.119. Epub 2014 Apr 8.
- Individual participant dataSharing planned: No
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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.
Satit Thiengwittayaporn, M.D. principal investigator
Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide and normal saline solution in people with Spinal Stenosis and Lumbosacral Spondylosis, run by Navamindradhiraj University at 1 site in Thailand.
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 2 inclusion and 6 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks (time frame: 2, 6, 12 weeks). The study lists 5 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 NCT02939482, which also lists 3 linked publications.
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 25 Jun 2019.