Informations générales (source: ClinicalTrials.gov)

NCT01799616 Statut inconnu
Interventional
  • Dorsalgie
  • Lombalgie
  • Dégénérescence de disque intervertébral
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
janvier 2013
mars 2015
29 juin 2024
The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France Patrick LACARIN En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

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- Age from 18 to 60 years old

- Low back pain

- Daily pain since at least 3 months

- VAS for pain > 40/100 during the last 48 hours

- Inefficiency, intolerance, or contraindication to NSAIDS

- Inefficiency of a rigid or half-rigid back brace

- Modic 1 discopathy (diagnosed on MRI and confirmed by trained radiologist)

- Dental check-up within the last 6 months

- Signed informed consent


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- Static disorders of the spine

- Contraindication to pamidronate (hypocalcemia, severe kidney failure, or allergy)

- Underage patients, patients under the protection of the law

- Previous treatment with bisphosphonates

- Pregnancy

- Local or general infection

- Previous discal surgery

- Systemic corticosteroid therapy in the last month

- Epidural or facet joint corticosteroid injection in the last month

- History of septic spondylodiscitis

- Ankylosing spondylitis

- Low back pain associated with radiculalgia

- Active psychiatric disorder

- Inability to read or understand French

- Body temperature above 38°C (fever) or Erythrocyte Sedimentation Rate above
20mm/hour