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.
- Males and females, 21 years of age or older
- Having mechanical low back pain (LBP) that is predominantly axial, i.e., subjects
with low back pain with proximal radiation (above the knee), or subjects with low
back pain with distal radiation of pain (below the knee), only if their low back pain
component is 50% or more than their leg pain component. This pain will have been
present for at least 3 months, with a minimum, average pain score of 4 on a 0-10
numeric rating scale [NRS; a score of 4 is associated with pain of "moderate"
intensity, and its use as a cutoff value is supported by the clinical relevance of
similar scores found by others.
- MRI evidence of multiple level disc degeneration and vertebral changes consistent
with the diagnosis of degenerative disc disease or spondylotic disease of the spine.
- Being capable of reading at a sixth-grade level.
- Prior back surgery
- Compression fracture(s)
- Cancer that can be a possible cause of the back pain
- MRI evidence of frank disk herniation or any other abnormality or pathology (other
than disc degeneration and vertebral changes consistent with the diagnosis of
degenerative disc disease or spondylotic disease of the spine) regarding the probable
cause of the patient's spinal pain; for example, arachnoiditis, moderate to severe
spinal canal stenosis, lateral recess stenosis, congenital malformation of the spine,
spinal nerve tumor, etc.
- Clinical diagnosis of relevant radiculopathic / neuropathic pain with leg pain, i.e.,
subjects with low back pain with distal radiation of pain (below the knee) if their
leg pain component is more than 50% than their back pain component, or subjects with
back pain with neurological deficits consistent with lumbosacral radiculopathy (upon
- Presumptive compression of a spinal nerve root or fracture of a pars interarticularis
(3) Spondylolisthesis (greater than grade one or more than 4 mm)
- A history of hypocalcemia
- Abnormal lab values:
- A baseline value for liver function that is 5% or more above the upper normal
- Upon the first laboratory screen, we will exclude anyone whose creatinine level
is more than 5% outside the normal range. Then, of those who have acceptable
creatinine levels, we will exclude anyone with a glomerular filtration rate
(GFR) that is less than 60. The GFR will be calculated according to Levey et al.
- The principal investigator will use his judgment regarding excluding any
individual with other abnormal lab values.
- A history of significant cardiac, hematological, renal, hepatic, metabolic,
endocrinological, or neurological disease
- An allergy to bisphosphonates
- Leukopenia or thrombocytopenia
- Being pregnant or nursing
- Diagnosis of painful polyneuropathy, e.g., painful diabetic neuropathy
- Psychotic symptoms. Dr. Barry Snow, the study consulting psychologist, will train
study staff to recognize these symptoms.
- Alcohol abuse or illicit drug use
- Receiving Worker's Compensation, or having a pending Worker's Compensation claim
- Being blind, deaf, or mute, or having a physical or mental handicap that impedes
administration of instruments that will provide outcome data
- Weighing less than 45 kg (this is rare for an adult)
- Subjects who are suicidal according to the Beck Depression Inventory, or score 26 and
above on the Beck Depression Inventory will be excluded from the study.
- Prior pamidronate treatment