Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large PopulationNCT01756196
Incidence of Various Types of Systemic Reactions Related to Spinal Steroid Injection: A Prospective Study
An observational study of Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection. Read more about this study
- Who is it for?
- Ages 13 to 94 yearsHealthy volunteers can take part
- Conditions the study is for
- Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population
- What is being tested?
- Spinal Steroid Injection
- Type of treatment
- Injection or infusion
- How many people
- 997 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2011
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 13 to 94 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients receiving the injection were informed of the aim and protocol of this study and the possible local and systemic reactions associated with spinal steroid injection
Who may be able to join
- Indicaion of steroid injction.
Who cannot join
- Contraindiation of steroid injction.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seoung Nam, Bundang, 463-802
About this study
Official title: Prospective Observational Study of Evaluate the Incidence and Types of Systemic Reactions After Spinal Steroid Injections
Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.
Read the detailed description
Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.
- Being tested
- Spinal Steroid Injection
- Keywords
- Spinal injection; Steroid; Systemic reaction; Complication; Side effect; Diabetes mellitus; Hypertension; Risk factor
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Steroid InjectionDrug
Steroid Injection
| Study group | Role | What they receive |
|---|---|---|
| Steroid Injection | Reactions associated with spinal steroid injection Receives: Drug: Spinal Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
episodes of systemic reactions after spinal steroid injection
Evaluation of episodes of systemic reactions after spinal steroid injection
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 posted25 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large PopulationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 997 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guen Young Lee, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756196
- Sponsor's protocol ID
- B-1008/016-004
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 25 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldstein G, Schlesinger DH. Thymopoietin and myasthenia gravis: neostigmine-responsive neuromuscular block produced in mice by a synthetic peptide fragment of thymopoietin. Lancet. 1975 Aug 9;2(7928):256-9. doi: 10.1016/s0140-6736(75)90966-6.
PubMed 49801
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Evaluate the Incidence and Types of Systemic Reactions After Spinal Steroid Injections
- ClinicalTrials.gov ID
- NCT01756196
- Acronym / sponsor ID
- B-1008/016-004
- Keywords
- Spinal injection; Steroid; Systemic reaction; Complication; Side effect; Diabetes mellitus; Hypertension; Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 997 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Dec 2012 (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.
Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.
Detailed description
Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steroid Injection | – | Drug: Spinal Steroid InjectionReactions associated with spinal steroid injection |
Who may qualify
- Ages
- 13 to 94 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving the injection were informed of the aim and protocol of this study and the possible local and systemic reactions associated with spinal steroid injection
Key inclusion criteria (1 listed)
- Indicaion of steroid injction.
Key exclusion criteria (1 listed)
- Contraindiation of steroid injction.
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 |
|---|---|---|
| Spinal Steroid InjectionSteroid Injection | Drug | Steroid Injection |
Primary outcome
episodes of systemic reactions after spinal steroid injection
Time frame: 2 weeks
Evaluation of episodes of systemic reactions after spinal steroid injection
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 Dec 2012.
- Results publication: PubMed 49801Goldstein G, Schlesinger DH. Thymopoietin and myasthenia gravis: neostigmine-responsive neuromuscular block produced in mice by a synthetic peptide fragment of thymopoietin. Lancet. 1975 Aug 9;2(7928):256-9. doi: 10.1016/s0140-6736(75)90966-6.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 25 Dec 2012. 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 South Korea. 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?
episodes of systemic reactions after spinal steroid injection (time frame: 2 weeks). 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 NCT01756196, 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 25 Dec 2012.