Low Back Pain Clinical Trial
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
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 pamidronate has proven effective in patients with
ankylosing spondylitis, and in painful bone diseases in general. We therefore hypothesized
that pamidronate would be effective in treating back pain associated with Modic type 1
changes.
This study aimed to determine pamidronate's efficiency in reducing pain, with the primary
outcome being a between-group difference of 30 points on a 100mm VAS at 3 months. Secondary
outcomes are the improvement in functional status and the drug's tolerance. Primary and
secondary outcome criteria will be assessed at each visit (inclusion, at 6 weeks, 3 months,
and 6 months). If the primary goal is not attained, a rigid or semi-rigid back brace will be
proposed to the patient, regardless of the treatment group.
In total, 48 patients will need to be recruited. These patients will be randomly assigned to
one of the two groups, with each group comprising 24 patients: one group will be given
pamidronate and the other placebo. Pamidronate will be administered at a dose of 90mg per
day, 2 days in a row, and every patient, regardless of the treatment group, will be given
paracetamol, in order to maintain blinding by preventing drug-induced fever.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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