SciaticaPhase 3DexhiaNCT05000658
Efficacy of Soluble Dexamethasone in Refractory Sciatica
A Phase 3 study testing Dexamethasone phosphate in people with Sciatica, run by Nantes University Hospital at 1 site in France.
Trial summary
This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable 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?
- Dexamethasone phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2021to 15 Mar 2023
- Phase
- Phase 3
- 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
- Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral
- Duration of evolution greater than 3 weeks despite analgesic / AINS treatment, and less than 3 months
- EVA sciatica pain > 4/10
- Oswestry 30 at inclusion
- Patient aged 18 years and older
- Patient affiliated to a social security scheme
Show all 28Show fewer
- Patient able to understand the protocol and having signed an informed consent
- Patient with an indication for corticosteroid infiltration in the context of their pathology
- Criteria for non-inclusion
- Signs or risks of infection, in particular signs of virosis
- Poor local skin condition
- Anticoagulation with VKA or anti-Xa, or haemorrhagic disease
- Neurological deficit < 3/5 or signs of cauda equina irritation
- Tarlov's cyst or low dural sac below week 4
- Hypersensitivity to Lidocaine, Dexamethasone, or any of its excipients
- Infiltration of the spine within the previous 3 months
- Patient with bilateral sciatica
- Patient with sciatica of osteoarthritic origin
- Patients with chronic respiratory insufficiency
- Pregnant or breastfeeding women or women refusing effective contraception until M3
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- Patient under court protection
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients unable to follow the protocol, as judged by the investigator
- Patient refusing to participate in the study
- Patient with clinically narrowed lumbar canal
- Patient with polyneuropathy or myelopathy
- Patient with sequelae of neuropathic pain
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo
This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica
Read the detailed description
Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm
- Conditions
- Sciatica
- Being tested
- Dexamethasone phosphate
- Keywords
- Reluctant Sciatica, Infiltrations, Soluble Dexamethasone
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone phosphateDrug
HSC injection of 4mL
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | HSC one injection of 4 mL soluble Dexamethasone phosphate (16 mg) (equivalent to 100 mg Prednisone), followed by up to 16 mL saline (depending on tolerance) Receives: Drug: Dexamethasone phosphate |
| group B | Placebo comparator | HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance) Receives: Drug: Dexamethasone phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness assessed by classical global algo-functional index: OSWESTRY
Measured: Week 3
Secondary outcomes (24)
Value of Eva scale for evaluated effectiveness on lower back pain
Measured: Month 6
Value of Eva scale for evaluated effectiveness on lower back pain
Measured: Week 1
Value of Eva scale for evaluated effectiveness on lower back pain
Measured: Week 3
Value of Eva scale for evaluated effectiveness on lower back pain
Measured: Week 6
Value of Eva scale for evaluated effectiveness on lower back pain
Measured: Month 3
Value of Eva scale for evaluated effectiveness on sciatic pain
Measured: Week 1
Value of Eva scale for evaluated effectiveness on sciatic pain
Measured: Week 3
Value of Eva scale for evaluated effectiveness on sciatic pain
Measured: Week 6
Value of Eva scale for evaluated effectiveness on sciatic pain
Measured: Month 6
Number of days off work
Measured: Month 6
Value of score to scale Oswestry
Measured: Month 6
Value of score to scale Oswestry
Measured: Week 1
Value of score to scale Oswestry
Measured: Week 6
Value of score to scale Oswestry
Measured: Month 3
Value of score to SF36 self questionnaires
Measured: Month 6
Value of score to SF36 self questionnaires
Measured: Week 1
Value of score to SF36 self questionnaires
Measured: Week 3
Value of score to SF36 self questionnaires
Measured: Week 6
Value of score to SF36 self questionnaires
Measured: Month 3
Percentage of second injections required
Measured: Month 6
Number of patients undergoing secondary surgery
Measured: Month 6
Result of Clinical parameters
Measured: week 3
Result of Imaging parameters
Measured: week 3
Number of secondary effects
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start16 Dec 2021
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
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 SciaticaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maugars, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000658
- Sponsor's protocol ID
- RC21_0148
- Acronym
- Dexhia
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maugars Y, Volteau C, Korner S, Arnolfo P. No Efficacy of Dexamethasone Injections for Acute Sciatica: A Double-Blind Randomized Study Versus Saline. Eur J Pain. 2026 Sep;30(8):e70373. doi: 10.1002/ejp.70373.
PubMed 42690210
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo
- ClinicalTrials.gov ID
- NCT05000658
- Acronym / sponsor ID
- Dexhia / RC21_0148
- Conditions
- Sciatica
- Keywords
- Reluctant Sciatica, Infiltrations, Soluble Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 11 Aug 2021 (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.
This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica
Detailed description
Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Dexamethasone phosphateHSC one injection of 4 mL soluble Dexamethasone phosphate (16 mg) (equivalent to 100 mg Prednisone), followed by up to 16 mL saline (depending on tolerance) |
| group B | Placebo comparator | Drug: Dexamethasone phosphateHSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral
- Duration of evolution greater than 3 weeks despite analgesic / AINS treatment, and less than 3 months
- EVA sciatica pain > 4/10
- Oswestry 30 at inclusion
- Patient aged 18 years and older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dexamethasone phosphateHSC injection of 4mL | Drug | group A, group B |
Primary outcome
Effectiveness assessed by classical global algo-functional index: OSWESTRY
Time frame: Week 3
24 secondary outcomes
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Month 6
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Week 1
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Week 3
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Week 6
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Month 3
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Week 1
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Week 3
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Week 6
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Month 6
Number of days off work
Time frame: Month 6
Value of score to scale Oswestry
Time frame: Month 6
Value of score to scale Oswestry
Time frame: Week 1
Value of score to scale Oswestry
Time frame: Week 6
Value of score to scale Oswestry
Time frame: Month 3
Value of score to SF36 self questionnaires
Time frame: Month 6
Value of score to SF36 self questionnaires
Time frame: Week 1
Value of score to SF36 self questionnaires
Time frame: Week 3
Value of score to SF36 self questionnaires
Time frame: Week 6
Value of score to SF36 self questionnaires
Time frame: Month 3
Percentage of second injections required
Time frame: Month 6
Number of patients undergoing secondary surgery
Time frame: Month 6
Result of Clinical parameters
Time frame: week 3
Result of Imaging parameters
Time frame: week 3
Number of secondary effects
Time frame: Month 6
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 1 Feb 2024.
- Derived from this study: PubMed 42690210Maugars Y, Volteau C, Korner S, Arnolfo P. No Efficacy of Dexamethasone Injections for Acute Sciatica: A Double-Blind Randomized Study Versus Saline. Eur J Pain. 2026 Sep;30(8):e70373. doi: 10.1002/ejp.70373.
- 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.
Maugars principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone phosphate in people with Sciatica, run by Nantes University Hospital 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 28 inclusion and 0 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 1 Feb 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Effectiveness assessed by classical global algo-functional index: OSWESTRY (time frame: Week 3). 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 NCT05000658, 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 1 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.