Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Dis… (NCT01799616) | Clinical Trial Compass
UnknownPhase 2
Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
France48 participantsStarted 2013-01
Plain-language summary
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
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- 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
Exclusion Criteria:
* \- 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