Status:
UNKNOWN
Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
INSERM CIC 501
Conditions:
Intervertebral Disc Degeneration
Modic I Discopathy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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
Detailed Description
Erosive degenerative disk disease, also known as Modic type 1 changes, is usually characterized by low back pain, with an inflammatory pain pattern, as seen in spondylarthropathies. Intravenous pamidr...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01799616
Start Date
January 1 2013
End Date
March 1 2015
Last Update
February 27 2013
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003