Status:
UNKNOWN
A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Low Back Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 healthcar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 examination)
- 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 limit
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00101790
Start Date
September 1 2003
End Date
June 1 2010
Last Update
January 7 2010
Active Locations (1)
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1
The Mount Sinai Medical Center
New York, New York, United States, 10029