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Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia (BetaDexaCaudal)

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ClinicalTrials.gov Identifier: NCT02833116
Recruitment Status : Unknown
Verified October 2016 by Enrique Manuel Barez Hernandez, Basque Health Service.
Recruitment status was:  Recruiting
First Posted : July 14, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Enrique Manuel Barez Hernandez, Basque Health Service

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Betamethasone Drug: Dexamethasone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group Betamethasone
One ampule containing 12 mg of betamethasone in a syringe of 10 ml
 Drug: Betamethasone
Active Comparator: Group Dexamethasone
One ampule containing 4 mg of dexamethasone in a syringe os 10 ml
 Drug: Dexamethasone


Outcome Measures
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Primary Outcome Measures :
  1. Pain. [ Time Frame: 3 months. ]
    Pain according to numerical visual pain scale.


Secondary Outcome Measures :
  1. Quality of life. [ Time Frame: 7 days, 1, 3 and 6 months. ]
    Quality of life according to SF-36.

  2. Pain. [ Time Frame: 7 days, 1, 3 and 6 months. ]
    Pain according to numerical visual pain scale.

  3. Adverse events. [ Time Frame: 7 days, 1, 3 and 6 months. ]
    Adverse events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Enrique Barez +34945007246 ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus
Contact: Amanda Lopez +34945007413 AMANDA.LOPEZPICADO@osakidetza.eus

Locations
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Spain
Enrique Barez Recruiting
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         
Sponsors and Collaborators
Basque Health Service
Investigators
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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
More Information
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Responsible Party: Enrique Manuel Barez Hernandez, Medical Doctor, Basque Health Service
ClinicalTrials.gov Identifier: NCT02833116    
Other Study ID Numbers: Beta-Dexa-Caudal
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Enrique Manuel Barez Hernandez, Basque Health Service:
radiculalgia
chronic pain
quality of life
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Dexamethasone
Betamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Asthmatic Agents
Respiratory System Agents