SciaticaHiatUSNCT02897336
Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica
A study testing ultrasound-guided and interlaminar in people with Sciatica, run by University Hospital, Caen at 1 site in France.
Trial summary
An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica
- What is being tested?
- ultrasound-guided and interlaminar
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radicular pain (sciatica or cruralgia) for more than 2 weeks
- failure of analgesics and NSAIDs
- without neurological deficiency (motor weakness lower or equal to 3/5)
- a lumbar disk herniation on MRI or CT dating less than 3 months
Who cannot join
- history of lumbar surgery
- history of epidural injection during the last 3 months
- radicular pain not due to disk herniation
- a contraindication to epidural injection (infection, diabetes)
- history of allergic reaction to corticosteroid
- patient under legal guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica
An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica.
Read the detailed description
An open-label randomized trial conducted in one centre to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica. 30 male and female patients will be included in each group. The primary outcome measure will be a 30% decrease in lower limbs pain as assessed by a visual analog scale.
- Conditions
- Sciatica
- Being tested
- ultrasound-guided, interlaminar
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guidedProcedure or surgery
ultrasound-guided caudal epidural corticosteroid injection
interlaminarProcedure or surgery
interlaminar epidural corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| ultrasound-guided | Experimental | ultrasound-guided caudal epidural corticosteroid injection Receives: Procedure: ultrasound-guided |
| interlaminar | Active comparator | interlaminar epidural corticosteroid injection Receives: Procedure: interlaminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower limbs pain
a 30% decrease in lower limbs pain using a visual analog scale
Measured: day 15
Secondary outcomes (7)
Oswestry questionnaire
low back pain disability assessment using Oswestry questionnaire
Measured: day 15 - month 1 - month 3 - month 6
A decrease of radicular pain with a pain numerical scale lower or equal to 3/10
pain numerical scale lower or equal to 3/10
Measured: day 15 - month 1 - month 3 - month 6
neurological deficiency assessed by neurological examination
motor weakness or sensitive deficiency in lower limbs
Measured: day 15 - month 1 - month 3 - month 6
drugs
decrease in analgesic treatment
Measured: day 15 - month 1 - month 3 - month 6
medical outcome
Medical Outcome study Short Form (SF-36)
Measured: day 15 - month 1 - month 3 - month 6
resumption of work
deadline of resumption of work
Measured: day 15 - month 1 - month 3 - month 6
number of patients with treatment-related adverse events as assessed by CTCAE v4.0
adverse events assessed by CTCAE v4.0
Measured: day 15 - month 1 - month 3 - month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897336
- Sponsor's protocol ID
- 2015-A01502-47
- Acronym
- HiatUS
- Status last verified
- Jan 2020
- First submitted
- 31 Aug 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica
- ClinicalTrials.gov ID
- NCT02897336
- Acronym / sponsor ID
- HiatUS / 2015-A01502-47
- Conditions
- Sciatica
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Sep 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.
An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica.
Detailed description
An open-label randomized trial conducted in one centre to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica. 30 male and female patients will be included in each group. The primary outcome measure will be a 30% decrease in lower limbs pain as assessed by a visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided | Experimental | Procedure: ultrasound-guidedultrasound-guided caudal epidural corticosteroid injection |
| interlaminar | Active comparator | Procedure: interlaminarinterlaminar epidural corticosteroid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- radicular pain (sciatica or cruralgia) for more than 2 weeks
- failure of analgesics and NSAIDs
- without neurological deficiency (motor weakness lower or equal to 3/5)
- a lumbar disk herniation on MRI or CT dating less than 3 months
Key exclusion criteria (6 listed)
- history of lumbar surgery
- history of epidural injection during the last 3 months
- radicular pain not due to disk herniation
- a contraindication to epidural injection (infection, diabetes)
- history of allergic reaction to corticosteroid
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 |
|---|---|---|
| ultrasound-guidedultrasound-guided caudal epidural corticosteroid injection | Procedure or surgery | ultrasound-guided |
| interlaminarinterlaminar epidural corticosteroid injection | Procedure or surgery | interlaminar |
Primary outcome
lower limbs pain
Time frame: day 15
a 30% decrease in lower limbs pain using a visual analog scale
7 secondary outcomes
Oswestry questionnaire
Time frame: day 15 - month 1 - month 3 - month 6
A decrease of radicular pain with a pain numerical scale lower or equal to 3/10
Time frame: day 15 - month 1 - month 3 - month 6
neurological deficiency assessed by neurological examination
Time frame: day 15 - month 1 - month 3 - month 6
drugs
Time frame: day 15 - month 1 - month 3 - month 6
medical outcome
Time frame: day 15 - month 1 - month 3 - month 6
resumption of work
Time frame: day 15 - month 1 - month 3 - month 6
number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: day 15 - month 1 - month 3 - month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided and interlaminar in people with Sciatica, run by University Hospital, Caen at 1 site in France.
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 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: withdrawn, as of the sponsor's last update on 31 Jan 2020. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
lower limbs pain (time frame: day 15). 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 31 Jan 2020.