Chronic PainPhase 4BetaDexaCaudalNCT02833116
Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia
A Phase 4 study testing Betamethasone and Dexamethasone in people with Chronic Pain, run by Basque Health Service at 1 site in Spain.
Trial summary
This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Betamethasone and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Jun 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc.
- Age between 18 and 80 years.
- Moderate to severe pain (NVS>4).
- Right proficient oral and written language.
Who cannot join
- Patients with high intracranial pressure.
- Patients with Multiple Sclerosis.
- Patients with Guillain-Barré syndrome radiculopathy of vascular origin.
- Patients with previous lumbar surgery.
- Patients pregnant or lactating.
- Patients with allergy or intolerance to any of the drugs used.
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- Patients with severe cognitive impairment.
- Patients with intrathecal injectio radiculalgia.
- Patients with poorly controlled major psychiatric pathology.
- Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac>8.5).
- Patients with glaucoma.
- Patients with caudal equine syndrome.
- Patients with pre-treatment with steroid injections/or local anesthetics.
- Patients with central canal stenosis.
- patients with chronic treatment with oral corticosteroids without stabilized pattern.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Enrique Barez
Vitoria-Gasteiz, Álava, 01009
Enrique Barez, +34945007275, ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus
Amanda Lopez, +34945007413, AMANDA.LOPEZPICADO@osakidetza.eus
About this study
Official title: Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial
This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.
- Conditions
- Chronic Pain
- Being tested
- Betamethasone, Dexamethasone
- Keywords
- radiculalgia, chronic pain, quality of life
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Group Betamethasone | Experimental | One ampule containing 12 mg of betamethasone in a syringe of 10 ml Receives: Drug: Betamethasone |
| Group Dexamethasone | Active comparator | One ampule containing 4 mg of dexamethasone in a syringe os 10 ml Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain.
Pain according to numerical visual pain scale.
Measured: 3 months.
Secondary outcomes (3)
Quality of life.
Quality of life according to SF-36.
Measured: 7 days, 1, 3 and 6 months.
Pain.
Pain according to numerical visual pain scale.
Measured: 7 days, 1, 3 and 6 months.
Adverse events.
Adverse events.
Measured: 7 days, 1, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Enrique Manuel Barez Hernandez, Basque Health Service
- Investigators
- Enrique Barez, Principal investigator, Basque Health Service: Araba University HospitalBorja Mugabure, Study director, Basque Health Service: Donosti University HospitalFernando Torre, Principal investigator, Basque Health Service: Galdakao University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833116
- Sponsor's protocol ID
- Beta-Dexa-Caudal
- Acronym
- BetaDexaCaudal
- Status last verified
- Oct 2016
- First submitted
- 12 Jul 2016
- Last updated
- 25 Oct 2016
- 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 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02833116
- Acronym / sponsor ID
- BetaDexaCaudal / Beta-Dexa-Caudal
- Conditions
- Chronic Pain
- Keywords
- radiculalgia, chronic pain, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 14 Jul 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.
This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Betamethasone | Experimental | Drug: BetamethasoneOne ampule containing 12 mg of betamethasone in a syringe of 10 ml |
| Group Dexamethasone | Active comparator | Drug: DexamethasoneOne ampule containing 4 mg of dexamethasone in a syringe os 10 ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc.
- Age between 18 and 80 years.
- Moderate to severe pain (NVS>4).
- Right proficient oral and written language.
Key exclusion criteria (15 listed)
- Patients with high intracranial pressure.
- Patients with Multiple Sclerosis.
- Patients with Guillain-Barré syndrome radiculopathy of vascular origin.
- Patients with previous lumbar surgery.
- Patients pregnant or lactating.
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 |
|---|---|---|
| Betamethasone | Drug | Group Betamethasone |
| Dexamethasone | Drug | Group Dexamethasone |
Primary outcome
Pain.
Time frame: 3 months.
Pain according to numerical visual pain scale.
3 secondary outcomes
Quality of life.
Time frame: 7 days, 1, 3 and 6 months.
Pain.
Time frame: 7 days, 1, 3 and 6 months.
Adverse events.
Time frame: 7 days, 1, 3 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- 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.
Enrique Barez principal investigator
Basque Health Service: Araba University Hospital
Borja Mugabure study director
Basque Health Service: Donosti University Hospital
Fernando Torre principal investigator
Basque Health Service: Galdakao 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 4 study testing Betamethasone and Dexamethasone in people with Chronic Pain, run by Basque Health Service at 1 site in Spain.
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 15 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. 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 Spain. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Barez (+34945007246, ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain. (time frame: 3 months.). 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 25 Oct 2016.