Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia (BetaDexaCaudal)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02833116|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Betamethasone Drug: Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2020|
Experimental: Group Betamethasone
One ampule containing 12 mg of betamethasone in a syringe of 10 ml
Active Comparator: Group Dexamethasone
One ampule containing 4 mg of dexamethasone in a syringe os 10 ml
- Pain. [ Time Frame: 3 months. ]Pain according to numerical visual pain scale.
- Quality of life. [ Time Frame: 7 days, 1, 3 and 6 months. ]Quality of life according to SF-36.
- Pain. [ Time Frame: 7 days, 1, 3 and 6 months. ]Pain according to numerical visual pain scale.
- Adverse events. [ Time Frame: 7 days, 1, 3 and 6 months. ]Adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833116
|Contact: Enrique Barez||+34945007246||ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus|
|Contact: Amanda Lopez||+34945007413||AMANDA.LOPEZPICADO@osakidetza.eus|
|Vitoria-Gasteiz, Álava, Spain, 01009|
|Contact: Enrique Barez +34945007275 ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus|
|Contact: Amanda Lopez +34945007413 AMANDA.LOPEZPICADO@osakidetza.eus|
|Principal Investigator: Borja Mugabure|
|Principal Investigator: Fernando Torre|
|Principal Investigator:||Enrique Barez||Basque Health Service: Araba University Hospital|
|Study Director:||Borja Mugabure||Basque Health Service: Donosti University Hospital|
|Principal Investigator:||Fernando Torre||Basque Health Service: Galdakao University Hospital|