Treatment of chronic mechanical spinal pain with intravenous pamidronate: A review of medical records

Marco Pappagallo; Brenda Breuer; Aaron Schneider; Kevin Sperber

doi:10.1016/S0885-3924(03)00201-X

We explored the effect of intravenous infusions of a bisphosphonate, pamidronate, in the management of chronic mechanical spinal pain, a worldwide public health problem in terms of lost workdays, medical treatment costs, and suffering. Bisphosphonates have an anti-nociceptive effect in animals. In humans, intravenous pamidronate relieves numerous painful conditions, including metastatic bone pain, ankylosing spondylitis, rheumatoid arthritis, and complex regional pain syndrome. We reviewed the charts of 25 patients who had experienced disabling spinal pain for several years, and whom we treated with intravenous pamidronate. None had a history of osteoporotic vertebral fractures or metastatic disease. Pain rating scores decreased in 91% of patients: on a 0-10 numeric rating scale, the mean pain change was -3.6 points and mean percentage change was -41% (P<0.0001). There was no increase in opioid or nonopioid analgesic medications associated with pain relief. The apparent analgesic effect of pamidronate for chronic mechanical spinal pain needs to be confirmed with placebo-controlled trials. © 2003 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.SCOPUS_ABS_SEPARATORPatients:25 patients (20 women, 5 men) with a median age of 54 years (range: 41 to 84), 14 were white (56%), 5 (20%) were Hispanic, and 3 (12%) were black. 3 patients were dropouts, 2 because they did not have pain relief from Aredia treatment and 1 because of flu-like symptoms after Aredia treatment. Follow-up was within 2 weeks post-infusion.SCOPUS_ABS_SEPARATORIndications:25 patients with debilitating, chronic, mechanical spinal pain. Coexisting disease was degenerative spondylotic disease.SCOPUS_ABS_SEPARATORTypeofStudy:The objective of this medical record review was to report the experience with Aredia for the treatment of debilitating, chronic, mechanical spinal pain in patients with no history of metastatic bone disease or osteoporotic vertebral fractures.SCOPUS_ABS_SEPARATORDosageDuration:A solution containing 90 mg Aredia dissolved in 10 cc of sterile water and 250 cc of 5% dextrose solution given iv over 4 hours. The patients received a series of monthly iv infusion at least 3 infusions within a period of three months. 20 completed three infusions (3 months duration), 2 had 2 infusions (2 months duration) and 1 had 1 infusion (single dose).SCOPUS_ABS_SEPARATORResults:20 patients completed the series of 3 infusions, 2 had 2 infusions, and 1 had 1 infusion. Compared to pre-treatment NRS pain scores, post-treatment scores were lower in 21 (91%) patients. The mean pain change was a decrease of 3.6 points (SD: 2.5; P< 0.0001), and the mean percentage change was decrease of 41% (SD: 29%; P< 0.0001). In 18 (78%) patients, the absolute reduction in the NRS pain score was greater or equal to 2.0 points, and in 13 (57%) patients, the percentage reduction in the NRS pain score was greater or equal to 30%. When the authors excluded the 7 patients whose interval between the baseline and final pain ratings was greater than 3.5 months, the results were similar; that is, the mean pain change was a decrease of 3.4 points (SD: 2.7; P< 0.0002). No significant relationship of percentage pain changes to age, ethnicity, or sex was found, (however, of the 23 subjects, only 4 were men). Among the patients not taking analgesics (nonopioids) before Aredia treatment, none were taking such medications after Aredia treatment. Three patients who had been taking nonopioid analgesics (example, NSAIDs) before treatment stopped taking them by the time they had completed their Aredia treatment. Although the correlation between changes in pain and opioid dose was small (r = 0.1, P = 0.7), the direction was positive; that is, those with pain reductions tended to have reduced their opioid medication.SCOPUS_ABS_SEPARATORAdverseEffects:1 patient developed flu-like syndrome and dropped out, 1 had some discomfort at the iv site and 40-50% (9-11 patients) develop mild diffuse body aches and transient fever. 2 withdrawals due to no pain relief.SCOPUS_ABS_SEPARATORAuthorsConclusions:Intravenous pamidronate therapy may be a promising treatment intervention in the management of chronic spinal pain. A definitive, double-blind, placebo-controlled, randomized clinical trial is warranted to confirm the apparent benefit of pamidronate for debilitating, chronic, spinal pain.SCOPUS_ABS_SEPARATORFreeText:The study is a review of the medical records of patients with disabling, chronic spinal pain who had come to the Comprehensive Pain Treatment Center (CPTC) of the Hospital for Joint Diseases Orthopaedic Institute, Mount Sinai-NYU Health, in New York City, between February 15, 2001, and August 15, 2001. The treated patients were affected by degenerative spondylotic disease, and presented with the chief complaint of chronic axial spinal pain. None of the patients had a history of dementia, hypocalcemia, renal disease, or liver disease. Prior to the infusion, all patients underwent routine blood tests including a comprehensive metabolic panel, thyroid function tests, and assessment of calcium and magnesium serum levels. The patients take approximately 1000 mg of a calcium oral supplementation per day throughout the treatment period. Further, patients underwent follow-up blood tests, including calcium and magnesium serum levels, within 2 weeks post-infusion. Part of the treatment protocol was the use of acetaminophen 500 mg or ibuprofen 400 mg tid from the day of the infusion through two days post-infusion. This treatment protocol precaution was found to be useful in improving patients' compliance with their subsequent Aredia infusions. Patients were asked to rate their pain on a 0-10 numeric rating scale (NRS), where 0 indicates no pain, and 10 indicates the worst pain imaginable. Differences between pain intensity levels at baseline (before the first infusion) and post-treatment (after the last infusion), and percentage differences of these scores (example, 100 [(baseline pain score pain score after final treatment)/baseline pain score]) were analyzed with the t test for matched pairs, using the SAS MEANS procedure. Relationships of pain changes to sex and ethnicity were evaluated with the TTEST procedure, and correlations between pain changes and age with the CORR procedure.

Treatment of chronic mechanical spinal pain with intravenous pamidronate: A review of medical records

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