Lumbar Disc HerniationPhase 4NCT03273036
Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy
A Phase 4 study testing 40 mg Triamcinolone acetate 1 cc in people with Lumbar Disc Herniation, run by Ramathibodi Hospital.
Trial summary
The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- 40 mg Triamcinolone acetate 1 cc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 1 May 2015
- Phase
- Phase 4
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed
Who cannot join
- Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid
About this study
Official title: Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.
The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.
Read the detailed description
To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo
- Conditions
- Lumbar Disc Herniation
- Being tested
- 40 mg Triamcinolone acetate 1 cc, Placebos
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg Triamcinolone acetate 1 ccDrug
40 mg Triamcinolone acetate 1 cc
PlacebosDrug
no injected agent
| Study group | Role | What they receive |
|---|---|---|
| epidural steroid injection | Active comparator | 40 mg triamcinolone acetate 1 cc Receives: Drug: 40 mg Triamcinolone acetate 1 cc |
| placebo injection | Placebo comparator | no injection agent Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative morphine consumption
Measured: Post operative 24 hour of morphine consumption in mg
Secondary outcomes (3)
Visual analog score (back and leg) 0-10
Measured: 1 day, 2, 6 ,12, 24 weeks
Oswestry disability index (ODI
Measured: 2, 6 ,12, 24 weeks
MacNab scores
Measured: 2, 6 ,12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 May 2014
- Primary completion1 May 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jatupon Kongtharvonskul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273036
- Sponsor's protocol ID
- ID 03-54-23
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03273036
- Acronym / sponsor ID
- ID 03-54-23
- Conditions
- Lumbar Disc Herniation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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 endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.
Detailed description
To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo
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 |
|---|---|---|
| epidural steroid injection | Active comparator | Drug: 40 mg Triamcinolone acetate 1 cc40 mg triamcinolone acetate 1 cc |
| placebo injection | Placebo comparator | Drug: Placebosno injection agent |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed
Key exclusion criteria (1 listed)
- Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid
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 |
|---|---|---|
| 40 mg Triamcinolone acetate 1 cc40 mg Triamcinolone acetate 1 cc | Drug | epidural steroid injection |
| Placebosno injected agent | Drug | placebo injection |
Primary outcome
Post-operative morphine consumption
Time frame: Post operative 24 hour of morphine consumption in mg
3 secondary outcomes
Visual analog score (back and leg) 0-10
Time frame: 1 day, 2, 6 ,12, 24 weeks
Oswestry disability index (ODI
Time frame: 2, 6 ,12, 24 weeks
MacNab scores
Time frame: 2, 6 ,12, 24 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 6 Sep 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 40 mg Triamcinolone acetate 1 cc in people with Lumbar Disc Herniation, run by Ramathibodi Hospital.
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 1 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 6 Sep 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-operative morphine consumption (time frame: Post operative 24 hour of morphine consumption in mg). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2017.