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Completed

NCT Number: NCT05000658

Efficacy of Soluble Dexamethasone in Refractory Sciatica

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone phosphate

Drug

HSC injection of 4mL

Primary outcomes

  1. Effectiveness assessed by classical global algo-functional index: OSWESTRY

    Time frame: Week 3

Secondary outcomes

  1. Value of Eva scale for evaluated effectiveness on lower back pain

    Time frame: Month 6

  2. Value of Eva scale for evaluated effectiveness on lower back pain

    Time frame: Week 1

  3. Value of Eva scale for evaluated effectiveness on lower back pain

    Time frame: Week 3

  4. Value of Eva scale for evaluated effectiveness on lower back pain

    Time frame: Week 6

  5. Value of Eva scale for evaluated effectiveness on lower back pain

    Time frame: Month 3

  6. Value of Eva scale for evaluated effectiveness on sciatic pain

    Time frame: Week 1

  7. Value of Eva scale for evaluated effectiveness on sciatic pain

    Time frame: Week 3

  8. Value of Eva scale for evaluated effectiveness on sciatic pain

    Time frame: Week 6

  9. Value of Eva scale for evaluated effectiveness on sciatic pain

    Time frame: Month 6

  10. Number of days off work

    Time frame: Month 6

  11. Value of score to scale Oswestry

    Time frame: Month 6

  12. Value of score to scale Oswestry

    Time frame: Week 1

  13. Value of score to scale Oswestry

    Time frame: Week 6

  14. Value of score to scale Oswestry

    Time frame: Month 3

  15. Value of score to SF36 self questionnaires

    Time frame: Month 6

  16. Value of score to SF36 self questionnaires

    Time frame: Week 1

  17. Value of score to SF36 self questionnaires

    Time frame: Week 3

  18. Value of score to SF36 self questionnaires

    Time frame: Week 6

  19. Value of score to SF36 self questionnaires

    Time frame: Month 3

  20. Percentage of second injections required

    Time frame: Month 6

  21. Number of patients undergoing secondary surgery

    Time frame: Month 6

  22. Result of Clinical parameters

    Time frame: week 3

  23. Result of Imaging parameters

    Time frame: week 3

  24. Number of secondary effects

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo

Acronym: Dexhia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2021
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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