Low Back Pain Clinical Trial
Official title:
A Pilot Trial of IV Pamidronate for Low Back Pain
The purpose of this study is to determine the test dose of pamidronate for treatment of low back pain in terms of safety, tolerability, and pain relief.
Chronic low back pain—an enormous clinical problem which affects large segments of
populations throughout the world—causes disability and loss of productivity, and leads to
enormous costs in healthcare resources. Efforts to find relatively non-invasive therapies
for individuals suffering from this problem are important.
The main objective of this single-center, double-blind study is to determine the optimal
dosing regimen—based on safety, tolerability, and pain relief— which should be used in
planning a future, large-scale, clinical study to clarify conclusively whether chronic low
back pain, unrelated to cancer, can be treated with pamidronate.
Forty-four persons will be recruited for participation. There will be four study groups,
each with 7 subjects randomly assigned to pamidronate and 4 to placebo. The dosage for the
pamidronate participants will be 30 mg of pamidronate for the first group, 60 mg for the
second group, and 90 mg for the third group. Members of the fourth group will receive 2
treatments of 90mg IV pamidronate or placebo.
In this study, scientists also hope to find out if the effectiveness of pamidronate can be
predicted with bone scans (a procedure used to see bone inflammation or injuries to the
bone), and if improvement in performance of daily tasks is related to the amount of
pamidronate a participant receives and to improvement in pain intensity, and to evaluate
patient satisfaction with the pamidronate treatments.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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