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A randomized, double-blind comparison of the addition of oxygenated glycerol triesters to topical mentholated cream for the treatment of acute musculoskeletal pain [Meeting Abstract]
Taylor, R; Gan, T J; Raffa, R B; Gharibo, C; Pappagallo, M; Sinclair, N R; Fleischer, C; Tabor, A
Background: Pain is one of the most undertreated healthcare problems in the world. Many patients treat their pain using a variety of OTC analgesics, such as acetaminophen, NSAIDs, and topical creams. Many topical products contain menthol, a derivative of peppermint oil, which has an analgesic effect associated with its cooling/warming sensation. It is unknown whether adding other known topical analgesics to menthol would enhance the analgesic effect. Essential oxygen oil is a novel topical preparation derived from naturally occurring ingredients that is commercially available OTC in Europe and the United States for treating minor aches and pains. In this study, the additive analgesic effect of combining essential oxygenated oil with menthol was analyzed for its effectiveness as a pain reliever. Methods: This study compared a topical analgesic product containing menthol to the same product with the addition of oxygenated glycerol triesters (OGTs) in 66 healthy adult subjects with acute musculoskeletal pain. Patients were randomized in a singlecenter, double-blind study to receive mentholated cream only (MC) or mentholated cream containing OGTs (OGT-MC) for a total of 7 days, applied three times a day. Patients self-reported their pain intensity, lifestyle limitations, and evaluated the mobility of the painful joint or muscle on a 100 mm visual analog scale. IRB approval was received before study was conducted. Results: Patients in both groups (MC and OGT-MC) experienced statistically significant pain relief on Day 8 over baseline, with the OGT-MC group reporting statistically significant greater pain relief than the MC group. Patients treated with OGT-MC experienced an incremental decrease of pain during each of the 7 days of treatment, indicating a cumulative analgesic effect due to continuous treatment. The OGT-MC group had lower VAS scores for the lifestyle and mobility examinations than the MC group. Both products were well tolerated with no serious adverse events and no signs of significant skin reactions. Conclusions: Essential oxygen oil (OGT-MC) is safe, effective, and provided significantly better pain relief than the mentholated cream alone. Continuous use of OGT-MC can be an effective alternative for other OTC treatments for reducing pain associated with minor aches or muscle pain
EMBASE:70864905
ISSN: 1754-3207
CID: 178261
Preliminary observations of a novel topical oil with analgesic properties for treatment of acute and chronic pain syndromes [Meeting Abstract]
Taylor, R; Pergolizzi, J V; Pappagallo, M; Gharibo, C; Raffa, R
Background: An estimated 50 million Americans live with chronic pain brought on by disease, disorder or accident with an additional 25 million Americans suffering from acute pain. Pain is complex because it has both physical and mental components and must be assessed subjectively. Medication that is effective in one patient may not be in another. Therefore, healthcare professionals need access to a range of therapeutic options to manage pain patients. Topical preparations therefore offer a useful alternative to systemic medications like opioids and NSAIDs. Essential oxygenated oil is a novel topical analgesic currently commercially available in Europe and in the US. It has been subject of several important clinical trials and it represents an important alternative to other treatments (NSAIDs, opioids) for managing moderate to severe acute and chronic pain. Methods: Overview of the novel analgesic including review of new data, existing unpublished data and a review of the literature. Studies referring to new and existing data received IRB approval before study was conducted. Results/Conclusions: A total of 5 studies ranging from 10 to 450 patients were analyzed in order to determine the efficacy and safety of the novel topical analgesic. Pain assessment was conducted in a variety of different pain models including arthritis, post-traumatic pain, postoperative pain, tendonitis, back pain, and sprains. In addition to pain assessment, mobility and stiffness were analyzed. Based on the studies completed, essential oxygen oil has not shown any serious adverse outcomes, has demonstrated positive analgesic effects for the treatment of acute and chronic pain, and has improved oxygen content in the skin as well as other dermatological parameters
EMBASE:70864906
ISSN: 1754-3207
CID: 178260
Interlaminar versus transforaminal epidural steroids for the treatment of subacute lumbar radicular pain: a randomized, blinded, prospective outcome study
Gharibo, Christopher G; Varlotta, Gerald P; Rhame, Ellen E; Liu, En-Chia James; Bendo, John A; Perloff, Michael D
BACKGROUND: There is uncertainty in the literature over the relative effectiveness of lumbar epidural interlaminar (IL) steroid injection versus transforaminal (TF) steroid injection for lumbar radiculopathy. Most studies to date have been retrospective, or technically focused. OBJECTIVE: To complete a randomized, blinded, prospective outcome study of the short-term benefit for IL versus TF epidural steroids for the treatment of subacute lumbar radicular pain. STUDY DESIGN: Prospective, randomized, blinded, subacute efficacy trial. SETTING: Tertiary care pain management center, major metropolitan city, United States METHODS: After institutional review board approval, 42 age-matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a patient and evaluating physician blinded trial to IL or TF epidural steroids from 2007 through 2009. Prior to intervention and 10-16 days after injection, each participant was evaluated by questionnaire and physical exam by an independent physician. All injections were performed by the same physician. Thirty-eight participants completed the study, 18 in the IL group and 20 in the TF group. Four participants required a repeat injection, and 2 participants crossed over to the alternative injection type (IL to TF). RESULTS: Overall, physical exam, diagnostic testing, disability, activity, depression measures, and opioid pill use were similar between the 2 groups, both pre-injection baseline and post-injection improvement. In primary outcomes, the post-injection follow-up Numeric Rating Scale (NRS) was more greatly reduced in the TF group. The NRS decreased from 7.0 +/- 1.9 to 3.9 +/- 3.1 (mean values +/- standard deviation) in the IL group and 6.4 +/- 2.1 to 1.7 +/- 1.4 in the TF group. The Oswestry Disability Index was reduced from 37.5 +/- 12.6 to 19.0 +/- 16.7 in the IL group and 38.3 +/- 6.4 to 21.6 +/- 16.8 in the TF group. In secondary outcomes, the depression scale was reduced from 4.39 +/- 3.22 to 2.28 +/- 3.20 in the IL group and 4.10 +/- 1.94 to 1.65 +/- 1.63 in the TF group. Walking tolerance was increased from 8.1 +/- 4.6 blocks to 10.6 +/- 4.4 in the IL group and 8.9 +/- 5.3 blocks to 11.8 +/- 4.2 in the TF group. LIMITATIONS: The study did not examine long-term outcomes. A single experienced interventionalist performed all injections. CONCLUSION: Results suggest that patients may experience greater subjective relief, at least initially, from TF epidural steroid injections over IL. However, more objective, and likely subacute, therapeutic effects are similar
PMID: 22086091
ISSN: 2150-1149
CID: 141704
Chronic pain syndromes
Chapter by: Gharibo, Christopher G; Kahn, M. Fahad
in: Medical aspects of disability : a handbook for the rehabilitation professional by Flanagan, Steven R; Zaretsky, Herbert H; Moroz, Alex [Eds]
New York : Springer, c2011
pp. 147-158
ISBN: 0826127843
CID: 5785
Interlaminar versus transforaminal epidural steroids for the treatment of lumbar radicular pain: A randomized, blinded, prospective outcome study [Meeting Abstract]
Perloff M.; Varlotta G.; Gharibo C.
Argument in the literature exists over lumbar epidural interlaminar steroid injection (LESI) verses transforminal (TF) technique as the most effective therapy in lumbar radiculopathy. However, all studies to date have been retrospective. After IRB approval, 42 age matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a double blind trial to LESI or TF from 2007 to 2009. Prior to intervention and 10-16 days after injection, each patient was evaluated by patient questionnaire and physical exam by an independent physician. 38 patients completed the study, 18 in the LESI and 20 in the TF group. In both groups, 2 patients required repeat injection, and 1 patient crossed over to the alternative injection type. Overall, physical exam, diagnostic testing, disability, activity and depression measures, and opioid pill use, were similar between the 2 groups, both pre-injection baseline and post-injection improvement. The Oswestry Disability Index (ODI%) was reduced from 37.5+/-12.6 (mean values +/- standard deviation) to 19.0+/-16.7 (49.3%+/-39.2%) in the LESI group and 38.3+/-6.4 to 21.6+/-16.8 (43.7%+/-34.8%) in the TF group. Depression scale was reduced from 4.39+/-3.22 to 2.28+/-3.20 (48.1%+/-52.0%) in the LESI group and 4.10+/-1.94 to 1.65+/-1.63 (61.0%+/-39.1) in the TF group. Walking tolerance was increased from 8.1+/-4.6 blocks to 10.6+/-4.4 (30.8%+/-133.2%) in the LESI group and 8.9+/-5.3 blocks to 11.8+/-4.2 (32.8%+/-318.7%) in the TF group. The follow-up patient numerical rating scale (NRS) was more greatly reduced in the TF group. NRS decreased from 7.0+/-1.9 to 3.9+/-3.1 (44.4%+/-37.6) in the LESI group and 6.4+/-2.1 to 1.7+/-1.4 in the TF group (73.2%+/-21.3%). Overall, results suggest that patients may experience greater subjective relief, as least initially, from TF epidural steroid injections over LESI. However, more objective, and likely subacute, therapeutic effects are similar
EMBASE:70392194
ISSN: 1526-5900
CID: 131849
The role of urine drug testing for patients on opioid therapy
Pergolizzi, Joseph; Pappagallo, Macro; Stauffer, Joseph; Gharibo, Christopher; Fortner, Neil; De Jesus, Mathew N; Brennan, Michael J; Richmond, Charlotte; Hussey, Desmond
Opioid analgesics must be prescribed with discernment and their appropriate use should be periodically assessed. Urine drug testing, although not designed specifically for this role, is a widely available and familiar method for monitoring opioid use in chronic pain patients. Urine drug testing can help track patient compliance and expose possible drug misuse and abuse. We sought to evaluate current attitudes and practices regarding the use of urine drug testing among chronic pain patients taking opioids. To the best of our knowledge, this is one of the first such attempts in the literature to examine and document the practice patterns of urine drug testing in this context. A total of 99 attendees at the American Congress of Pain Medicine were surveyed in 2008 about their urine testing practices for patients on opioid therapy. Surprisingly, more urine testing was motivated by a desire to detect undisclosed substances than to evaluate appropriate opioid use. Some respondents never urine-tested their opioid patients, and about two-thirds of respondents had no formal training in urine testing of patients on opioid therapy. The literature does not thoroughly address the role of urine drug testing in this patient population. Most respondents did random rather than scheduled testing; few had any urine testing protocol. The study found motivations for urine testing and testing practices varied widely, and urine testing, despite its clinical utility, is not used consistently.
PMID: 20412503
ISSN: 1530-7085
CID: 812022
The role of radiofrequency ablation for sacroiliac joint pain: a meta-analysis
Aydin, Steve M; Gharibo, Christopher G; Mehnert, Michael; Stitik, Todd P
Radiofrequency ablation (RFA) has become an option for those with chronic or refractory sacroiliac (SI) joint pain. The purpose of this critical review is to assess the existing literature and conduct a meta-analysis to assess the effectiveness of RFA of the SI joint for pain relief at 3 and 6 months' after an RFA procedure. An electronic search of PubMed, OVID, Medline, and CINAHL were conducted with keywords; sacroiliac joint, sacroiliac pain, sacroiliac syndrome, sacroiliac radiofrequency ablation, sacroiliac neurolysis, sacroiliac injection, and low back pain. Articles that addressed RFA of the SI joint were reviewed. Ten articles ranging from inception to January 1, 2010, were found. The main outcome measure was a reduction of pain by >/=50% post-RFA procedure. At 3 months, 7 groups met the criteria and at 6 months, 6 groups met the criteria. A meta-analysis with a forest plot was done at the 3- and 6-month patient follow-up intervals. The associated standard error was calculated for each study group. An overall weighted average with respective standard error was also obtained. A calculation of 95% confidence intervals (95% CI) was then derived. A test for heterogeneity, publication bias, and file drawer effect was also done at the 3- and 6-month intervals. At 3 months, a range of 0.538-0.693 was found to have a 95% CI, with a pooled mean of 0.616. At 6 months, a 95% CI of 0.423-0.576 was found, with a pooled mean of 0.499. The meta-analysis demonstrated that RFA is an effective treatment for SI joint pain at 3 months and 6 months. This study is limited by the available literature and lack of randomized controlled trials. Further standardization of RFA lesion techniques needs to be established, coupled with prospective randomized controlled trials.
PMID: 20869684
ISSN: 1934-1482
CID: 812032
Preliminary observations of a novel topical oil with analgesic properties for treatment of acute and chronic pain syndromes
Pergolizzi, Joseph V; Pappagallo, Marco; Raffa, Robert B; Gharibo, Chris; Phillips, Reed B; Desjonqueres, Stephane; Tabor, Aaron
OBJECTIVE: Essential oxygen oil (OxyRub from CreoMed Inc., Naples, FL, U.S.A.) is a novel topical analgesic currently commercially available in Europe and now available in the U.S.A. It represents an important alternative to other treatments (nonsteroidal anti-inflammatory drugs, acetaminophen, menthol, camphor) for managing mild to moderate acute and chronic pain. Several clinical trials of this oil will be reviewed. RESULTS: One large (n = 455) open-label trial found essential oxygen oil to be a safe and effective analgesic for a broad range of patients with acute and chronic pain. In that study, 80% of patients reported that their pain decreased by more than 75%. A double-blind placebo-controlled study (n = 50) found significant pain reduction for tendonitis in patients using essential oxygen oil. Another trial of essential oxygen oil vs. placebo (n = 50) with various pain diagnoses found that 98% of patients with various pain diagnoses reported 'very good' pain relief in the oil group compared to 48% in the placebo group. Furthermore, a randomized controlled trial in 10 women to measure oxygen microcirculatory effect in the skin showed an increased microcirculatory effect with improved oxygenation (increased partial pressure of oxygen in the skin) after application of essential oxygen oil. In all studies, the oil was well tolerated. None of these studies has been previously published. CONCLUSIONS: Based on studies completed, essential oxygen oil has shown itself to be safe, has demonstrated positive analgesic effects for the treatment of acute and chronic pain, and has improved oxygen content in the skin as well as other dermatological parameters
PMID: 20230451
ISSN: 1533-2500
CID: 133769
Oral prednisone response as an indicator for pain reduction with epidural injection in the treatment of lumbosacra radiculopathy [Meeting Abstract]
Chung J.; Gharibo C.
It is estimated that 10 million Americans are disabled by low back pain and lumbosacral radiculopathy (LSR), which leads to approximately 19 million physician visits per year. While there is debate over the best treatment paradigm for LSR, steroids are among the mainstays. Oral and epidural steroids have both shown favorable results in LSR. The purpose of this study is to evaluate whether response to oral steroids is a predictor of response to epidural steroid injections (ESI). Methods: A retrospective study of 142 patients with LSR presenting to the NYU Pain Management Center with >1 month of symptoms. Thirty two subjects received a five day course of oral prednisone 10 mg four times per day, and were later given interlaminar ESI when the oral steroids did not help or when the pain returned. All injections were administered under fluoroscopy, with epidural injectate consisting of 80 mg of DepoMedrol and 2 cc 0.9 NS. After 2 weeks, patients were assessed for pain relief on a scale of 0 to 10. Results: Of 32 people receiving oral steroids, 16 reported pain relief (>40% reductionresponders), with mean improvement score of 7 points, and 14 subjects did not show improvement (non-responders). After receiving ESI, both the responders and nonresponders had 70% pain reduction. Conclusion: Failure of oral steroids does not prognosticate failure of epidural steroids. Patients who did not respond to oral steroids can still get excellent pain relief after epidural steroid injections
EMBASE:70212014
ISSN: 1526-2375
CID: 111399
Rapid acting analgesics
DeNatale C.E.; Rosenberg A.; Gharibo C.
A majority of patients with acute and chronic pain experience breakthrough pain above their baseline, despite a fixed regimen. The characteristics of current short-acting oral medications are not optimal because they often peak too late and last beyond the duration of pain. Oral absorption limits the onset time, whereas the development of newer routes can shorten onset times. A number of medications, both opioid and nonopioid, are being developed for intranasal delivery with promising results. In addition to the intranasal administration route being efficacious, it also provides better patient satisfaction by allowing the patient to titrate their own pain medication. There are legitimate concerns for abuse and addiction with these medications, which will need to be minimized with proper dispensing modifications. A number of nonopioid agents are also entering the market that will allow for multimechanistic analgesic plans. Although ketamine is not a common component of current pain treatment plans, the development of an intranasal formulation may potentially produce wider acceptance. Many traditional medications, including ibuprofen and acetaminophen, have been developed for parenteral administration. Intravenous ibuprofen or diclofenac can be administered for a longer duration and have a lower bleeding risk then ketorolac. Intravenous acetaminophen can provide balanced analgesia when nonsteroidal anti-inflammatory drugs are contraindicated, as is common in the postoperative period. The role of individual agents in each specialty is not currently clear, but the future treatment of pain, both acute and chronic, is brighter with the addition of these formulations
EMBASE:2010326762
ISSN: 1084-208x
CID: 110161