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Efficacy of Soluble Dexamethasone in Refractory Sciatica (Dexhia)

Primary Purpose

Sciatica

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dexamethasone phosphate
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring Reluctant Sciatica, Infiltrations, Soluble Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Nantes University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

group A

group B

Arm Description

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)

HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)

Outcomes

Primary Outcome Measures

Effectiveness assessed by classical global algo-functional index: OSWESTRY

Secondary Outcome Measures

Value of Eva scale for evaluated effectiveness on lower back pain
Value of Eva scale for evaluated effectiveness on lower back pain
Value of Eva scale for evaluated effectiveness on lower back pain
Value of Eva scale for evaluated effectiveness on lower back pain
Value of Eva scale for evaluated effectiveness on lower back pain
Value of Eva scale for evaluated effectiveness on sciatic pain
Value of Eva scale for evaluated effectiveness on sciatic pain
Value of Eva scale for evaluated effectiveness on sciatic pain
Value of Eva scale for evaluated effectiveness on sciatic pain
Number of days off work
Value of score to scale Oswestry
Value of score to scale Oswestry
Value of score to scale Oswestry
Value of score to scale Oswestry
Value of score to SF36 self questionnaires
Value of score to SF36 self questionnaires
Value of score to SF36 self questionnaires
Value of score to SF36 self questionnaires
Value of score to SF36 self questionnaires
Percentage of second injections required
Number of patients undergoing secondary surgery
Result of Clinical parameters
Result of Imaging parameters
Number of secondary effects

Full Information

First Posted
August 4, 2021
Last Updated
April 11, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05000658
Brief Title
Efficacy of Soluble Dexamethasone in Refractory Sciatica
Acronym
Dexhia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
Reluctant Sciatica, Infiltrations, Soluble Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
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)
Arm Title
group B
Arm Type
Placebo Comparator
Arm Description
HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone phosphate
Intervention Description
HSC injection of 4mL
Primary Outcome Measure Information:
Title
Effectiveness assessed by classical global algo-functional index: OSWESTRY
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
Value of Eva scale for evaluated effectiveness on lower back pain
Time Frame
Month 6
Title
Value of Eva scale for evaluated effectiveness on lower back pain
Time Frame
Week 1
Title
Value of Eva scale for evaluated effectiveness on lower back pain
Time Frame
Week 3
Title
Value of Eva scale for evaluated effectiveness on lower back pain
Time Frame
Week 6
Title
Value of Eva scale for evaluated effectiveness on lower back pain
Time Frame
Month 3
Title
Value of Eva scale for evaluated effectiveness on sciatic pain
Time Frame
Week 1
Title
Value of Eva scale for evaluated effectiveness on sciatic pain
Time Frame
Week 3
Title
Value of Eva scale for evaluated effectiveness on sciatic pain
Time Frame
Week 6
Title
Value of Eva scale for evaluated effectiveness on sciatic pain
Time Frame
Month 6
Title
Number of days off work
Time Frame
Month 6
Title
Value of score to scale Oswestry
Time Frame
Month 6
Title
Value of score to scale Oswestry
Time Frame
Week 1
Title
Value of score to scale Oswestry
Time Frame
Week 6
Title
Value of score to scale Oswestry
Time Frame
Month 3
Title
Value of score to SF36 self questionnaires
Time Frame
Month 6
Title
Value of score to SF36 self questionnaires
Time Frame
Week 1
Title
Value of score to SF36 self questionnaires
Time Frame
Week 3
Title
Value of score to SF36 self questionnaires
Time Frame
Week 6
Title
Value of score to SF36 self questionnaires
Time Frame
Month 3
Title
Percentage of second injections required
Time Frame
Month 6
Title
Number of patients undergoing secondary surgery
Time Frame
Month 6
Title
Result of Clinical parameters
Time Frame
week 3
Title
Result of Imaging parameters
Time Frame
week 3
Title
Number of secondary effects
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maugars
Phone
0240084820
Email
yves.maugars@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maugars
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maugar
Phone
0240084820

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Soluble Dexamethasone in Refractory Sciatica

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