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March-April 2007; Issue 8AHA Modifies NSAID Recommendations Common Analgesics May Increase Hypertension in Men Adults Unaware of Potential Acetaminophen Harms Ibuprofen + Aspirin May Increase Cardiac Risks Ibuprofen Best for Children’s Musculoskeletal Pain Chondroitin Ineffective for Osteoarthritis Pain Ulnar Fovea Sign Defines Unexplained Wrist Pain Practice Guidelines Revised for Anesthesia in Childbirth Fentanyl Buccal Tablet Relieves Breakthrough Pain Bone Tumor Pain Relieved by Radiofrequency Ablation Trauma, PTSD Affect Chronic Pelvic Pain in Women Hydromorphone in UDT May Show Morphine Compliance Recent Drug and Device Approvals and Announcements This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; Steven J. Tucker, MD. Posting Date: April 24, 2007. Where noted, product brand names are for informational purposes only and are registered trademarks of their respective manufacturers. In some cases, additional brands may be available for specific products. AHA Modifies NSAID RecommendationsTo provide guidance on the use of nonsteroidal anit-inflammatory drugs (NSAIDs) in patients with heart disease, the American Heart Association (AHA) has published current treatment recommendations in the March issue of their journal Circulation. An expert panel evaluated recent research including 121 studies with a combined total of more than 30,000 patients. Of particular interest were studies showing convincing evidence of an increased risk of complications for patients with cardiovascular disease or existing cardiac risk factors. To reduce the potential danger of cardiovascular complications – including myocardial infarction, stroke, heart failure, and hypertension – the AHA is recommending a stepped approach to drug therapy. Highlights of the new recommendations for treating pain in patients with known cardiovascular disease or existing risk factors for ischemic heart disease include:
Clinical Implications: In this statement from the American Heart Association, healthcare providers are cautioned to change their approach to prescribing pain relievers for patients at risk of heart disease. When choosing medications, the least risky should be tried first – usually acetaminophen or aspirin – and at the lowest effective dose. The AHA includes the use of opioid analgesics as a first-line option for short-term relief in acute pain situations. It is important to attempt to find a balance between the risks of long-term drug therapy and the pharmacologic benefits of pain relief for each individual patient.
Reference: Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal anti-inflammatory drugs: an update for clinicians. A scientific statement from the American Heart Association. Circulation. 2007(Mar);115(12):1634-1642. < Back to Top > Common Analgesics May Increase Hypertension in MenThe use of over-the-counter, nonopioid analgesic medications for pain management has become common practice. A study published recently in the Archives of Internal Medicine evaluated the risk of incident hypertension with the use of acetaminophen, nonsteroidal anit-inflammatory products (NSAIDs), or aspirin. The study population consisted of 16,031 middle-aged men with no history of hypertension who were participants in an ongoing prospective cohort study of male health professionals, the Health Professionals Follow-Up Study. Data regarding the frequency of use and total pill consumption was collected by self-report questionnaires at baseline and at the 2-year period. Follow-up questionnaires to gather data on incident hypertension were sent to participants at 2- and 4-year points post-baseline. During the 4-year study period, a total 1,968 participants across the 3 analgesic classes reported a new diagnosis of hypertension. When compared with nonusers, the men who took acetaminophen 6 to 7 times each week had a significant relative risk of 1.34 (p = .01) for incident hypertension. Based on the same frequency of use, the relative risks were similar for NSAIDs (1.38; p = .002) and aspirin (1.26; p < .001). Relative risk results were similar in an analysis of pill-quantity consumption, rather than just frequency of use. While all 3 drug classes showed significant independent associations for a moderate increase in the risk of incident hypertension, there were no significant associations between an increased risk of hypertension and body mass index or age in this population. Clinical Concepts: The researchers stated that the average age of participants was about 65 years (range: 57-71) and acknowledged the possibility that a broader range might show an age association. And, while the self-reported results could be construed as a weakness, the participants in this study were health professionals and all previous reports of hypertension had been shown to be highly reliable. The results of this investigation supported the outcomes of previous studies, which have suggested that analgesic use may be associated with an increased risk of hypertension. Furthermore, outcomes in this study were not stratified by pain condition, which in itself might have affected cardiovascular health independent of analgesic use. With reports of an increasing prevalence of hypertension and the common use of over-the-counter analgesic medications, healthcare professionals can help to increase public awareness of these study results and use this data to aid the evaluation of each patient’s risk-benefit potential. Source: Forman JP, Rimm EB, Curhan GC. Frequency of analgesic use and risk of hypertension among men. Arch Intern Med. 2007(Feb);167(4):394-399. < Back to Top > Adults Unaware of Potential Acetaminophen HarmsAcetaminophen is a commonly used analgesic that, while generally safe, can cause mortality or morbidity due to unintentional overdose or an ideopathic reaction. A cross-sectional, prospective study of 104 patients (mean age 52.3 +/- 15.3) from one adult internal medicine clinic evaluated user knowledge of safe acetaminophen dosing, their awareness of acetaminophen-containing products, and the potential dangers of high doses. While almost 70% of participants reported daily or weekly episodes of pain and almost 80% of them used acetaminophen in the past 6 months, only 5 patients were able to accurately identify the maximum daily safe dose of regular or extra-strength acetaminophen. More than 60% of respondents stated that they had not received or were unsure if they had ever received information alerting them to the potential dangers of overdosing. Only about 43% of patients were aware that liver damage was a concern, while 53% were unsure of the nature of possible health problems. More than 70% of participants correctly identified Tylenol® as containing acetaminophen, but less than 15% were aware that products like Vicodin®, Percocet®, Darvocet®, Lorcet®, and Tylox® contained the drug. Furthermore, Motrin®, ibuprofen, Sudafed®, Aleve®, and Benadryl® were incorrectly selected by up to 19% of patients as products that also contained acetaminophen. Clinical Implications: The results of this study indicate that patients with pain are frequently unaware of the dangers of exceeding the maximum recommended dose of the acetaminophen-containing products they use, or that the drug is the most common cause of acute liver failure in the United States. There was no apparent correlation between knowledge of the consequences of acetaminophen toxicity and patient age, education, or race/ethnicity. This study demonstrates a need for healthcare providers to be aware of recommended acetaminophen dosages by product, and the potential dangers of unintentional overdose of this pain reliever – and then to communicate this information to patients.
Reference: Stumpf JL, Skyles AJ, Alaniz C, et al. Knowledge of appropriate acetaminophen doses and potential toxicities in an adult clinic population. J Am Pharm Assoc. 2007(Jan-Feb);47(1):35-41. < Back to Top > Ibuprofen + Aspirin May Increase Cardiac RisksEvidence has suggested that both selective cyclooxygenase (COX)-2 inhibitors and non-selective NSAIDs increase risks of cardiovascular (CV) events. However, risks of COX-2 inhibitors or non-selective NSAIDs in high CV risk patients taking aspirin have been unknown. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) of 18,325 osteoarthritis patients compared treatment with lumiracoxib (a COX-2 inhibitor) to either ibuprofen or naproxen. [Lumiracoxib is marketed in 21 countries under the brand name Prexige®, but FDA approval in the US is still pending.] A post hoc analysis stratified by baseline cardiovascular risk, treatment assignment, and low-dose aspirin use evaluated the primary endpoints of cardiovascular mortality, nonfatal myocardial infarction, and stroke at 1 year; a secondary endpoint was the development of congestive heart failure (CHF). Among high risk, aspirin-using patients, those taking ibuprofen had nearly 9 times more primary events with ibuprofen than lumiracoxib, whereas primary events in those taking naproxen were similar to lumiracoxib. High risk patients not taking aspirin had fewer primary events with naproxen vs lumiracoxib, but not ibuprofen versus lumiracoxib. Overall, CHF developed more 11-fold often with ibuprofen than lumiracoxib, whereas no difference existed between naproxen and lumiracoxib. Clinical Implications: These data suggest that, among aspirin-using patients at high cardiovascular risk, ibuprofen may confer significantly increased risks of thrombotic and CHF events relative to the COX-2 inhibitor lumiracoxib or naproxen. Possibly, ibuprofen may cancel the cardioprotective effects of daily low-dose aspirin. In non-aspirin-using, high risk patients naproxen may be associated with lower risks relative to either lumiracoxib or ibuprofen. However, since these outcomes are based on post hoc analyses, they should be interpreted as hypothesis-generating until confirmatory prospective trials are conducted. Reference: Farkouh ME, Greenberg JD, Jeger RV, et al. Cardiovascular outcomes in high-risk patients with osteoarthritis treated with ibuprofen, naproxen, or lumiracoxib. Ann Rheum Dis. Published online ahead of print April 5, 2007. < Back to Top > Ibuprofen Best for Children’s Musculoskeletal PainA study published in the March issue of the journal Pediatrics reported that ibuprofen was the most effective analgesic for children experiencing acute pain from musculoskeletal injuries.Emergency room patients, ages 6 to 17 years, were randomly assigned to one of 3 oral medications for the pain of a neck, back, or extremity injury that had occurred in the 48 hours prior to admission. Parents, children, and research assistants were blinded to the medication group; either 15 mg/kg acetaminophen, 10 mg/kg ibuprofen, or 1 mg/kg codeine were administered orally to 336 patients. A visual analog measure (100 mm scale) of the change in pain from baseline to one hour after treatment represented the primary outcome measurement; “adequate” pain reduction was defined as a score of < 30 mm post-treatment. The total number of patients analyzed was 300 (100 in each treatment group). At the half hour point, the 3 groups recorded similar pain measurements. But, at 60 minutes post-treatment, the ibuprofen group reported a significant reduction (24 points) in the mean pain score, compared with 12 points and 11 points for the acetaminophen and codeine groups, respectively. Furthermore, a total of 52% of the ibuprofen-treated children reported “adequate” pain relief at one hour, compared with 40% of the patients in the codeine group and 36% who received acetaminophen. No major side effects were reported in this single dose study. Practice Perspectives: The researchers suggested that ibuprofen may provide more pain relief in traumatic injuries because it targets inflammation, while acetaminophen and codeine do not. Since previous emergency department studies have shown that children frequently receive inadequate pain relief, it is noteworthy that ibuprofen provided more significant pain relief than acetaminophen or codeine in this population. However, just under half of this group still did not achieve “adequate” pain relief, so ibuprofen alone will not provide adequate relief in all cases for children with musculoskeletal injuries. [Other NSAIDs were not tested in this study, and might provide equivalent or greater analgesia in this population as an alternative. – SBL] Reference: Clark E, Plint AC, Correll R, et al. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007(Mar);119(3):460-467. < Back to Top > Chondroitin Ineffective for Osteoarthritis PainChondroitin is believed to help draw fluid into joint cartilage, making it more flexible; however, a new analysis of 20 studies found no evidence that the popular supplement prevents or reduces joint pain. Although previous meta-analyses described moderate to large benefits of chondroitin in patients with osteoarthritis, recent large-scale trials did confirm evidence of an effect. Swiss researchers culled major databases for relevant articles, spanning 1970 to 2006. Twenty trials (encompassing 3,846 patients) met inclusion criteria and contributed to the meta-analysis. Small trials, those with unclear concealment of allocation, and trials that were not analyzed according to the intention-to-treat principle showed larger effects in favor of chondroitin than did the remaining trials. When the authors restricted their analysis to the 3 trials with large sample sizes and an intention-to-treat analysis, 40% of patients were included. This resulted in a small negative effect (-0.03) for chondroitin and corresponded to a difference of only 0.6 mm on a 10 cm visual analogue pain scale. Practice Pointers: Trial quality was generally low and heterogeneity among the trials made initial interpretation of results difficult. The authors concluded that the few available large-scale, methodologically sound trials indicated that the symptomatic benefit of chondroitin is minimal or nonexistent. Therefore, use of chondroitin in routine clinical practice might be discouraged. However, this investigation did not rule out the possibility that chondroitin may lessen pain in patients with less severe arthritis, since the most rigorous studies tended to only include patients with more severe arthritis. In an editorial accompanying the research report, David Felson, an osteoarthritis expert at Boston University, commented that, despite the findings, some patients are convinced that chondroitin helps, and he believes there may be no "harm in encouraging them to continue taking it as long as they perceive a benefit."
Source: Reichenbach S, Sterchi R, Scherer M, et al. Meta-analysis: Chondroitin for Osteoarthritis of the Knee or Hip. Ann Int Med. 2007(Apr):146(8): 580-590 < Back to Top > Ulnar Fovea Sign Defines Unexplained Wrist Pain
The Ulnar Fovea Sign is elicited with the patient sitting, elbow on table, opposite the examining practitioner (see photo). The patient’s hand is supported to keep the forearm vertical and in neutral rotation, and wrist in neutral position. The practitioner’s thumb tip is then pressed deep into the interval “soft spot” between the ulnar styloid process, flexor carpi ulnaris tendon, volar surface of the ulnar head, and the pisiform. The Ulnar Fovea Sign is positive when there is exquisite tenderness compared with the contralateral side. This tenderness must replicate the patient’s complaint of pain in terms of character and location. The clinical and surgical records of 272 patients who underwent wrist arthroscopy procedures by one practitioner were evaluated. During arthroscopy, a total of 90 patients were diagnosed with a foveal disruption of the distal radioulnar ligament and 68 patients had ulnotriquentral (UT) ligament injuries. Foveal ligament disruption can result from a high pressure trauma, like a fall, which could cause the entire ligament to detach from the ulna. A UT-ligament injury can be caused by an avulsion or a tear that could occur from repetitive torque, such as that associated with golf or bowling. These 2 injuries are frequent causes of ulnar-sided wrist pain and, in this study, the Ulnar Fovea Sign sensitivity for the detection of either condition was about 95% and the specificity was approximately 86%. Clinical Implications: The results of this analysis imply that this Ulnar Fovea Sign has diagnostic usefulness for the symptomatic patient who has not experienced pain relief with nonsurgical interventions. Reference: Tay SC, Tomita K, Berger RA. The “ulnar fovea sign” for defining ulnar wrist pain: an analysis of sensitivity and specificity. J Hand Surg [Am]. 2007(Apr);32(4):438-444. < Back to Top > Practice Guidelines Revised for Anesthesia in ChildbirthThe American Society of Anesthesiologists (ASA) Task Force on Obstetric Anesthesia has reviewed evidence-based literature and invited the opinions of a panel of consultants and practitioners to develop an update for guidelines originally adopted in 1998. The update, published in the April issue of Anesthesiology, provide expanded recommendations for pain management during labor, operative and nonoperative deliveries, and the postpartum period. Each recommendation is supported by a strength-of-evidence evaluation and the guideline appendix includes a meta-analysis summary, as well as the results of consultant opinion survey on the feasibility of implementing all key recommendations. Several important recommendations in the updated guidelines include:
Conclusion/Commentary: In a related news story, the chair of the ASA Task Force, Joy Hawkins, MD, stated, “for the women who request anesthesia, there are many options for pain relief depending on the patient’s medical status, the progress of labor, and the resources available.” She adds, “the revised practice guidelines do not guarantee specific outcomes, but provide basic recommendations based on a synthesis of expert research and recommendations.”
Reference: American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice Guidelines for Obstetric Anesthesia. Anesthesiology. 2007(APR);106(4):843-863. < Back to Top > Fentanyl Buccal Tablet Relieves Breakthrough PainThe fentanyl buccal tablet (FBT) is a new rapid-onset effervescent formulation that is placed between the cheek and gum and takes 10-15 minutes to dissolve. A randomized, open-label, placebo-controlled study was conducted to evaluate the effectiveness of FBT for breakthrough pain in patients with chronic low back pain. Patients (n=77) from 16 pain treatment centers were instructed to complete a self-administered dose-titration phase of the study and, subsequently, were assigned to 1 of 3 groups for the double-blind phase. Once the effective FBT dose (100 – 800 micrograms) was identified for each patient, random assignment was made to a prespecified treatment sequence group (2 FBT treatments and 1 placebo treatment in varied order) encompassing 3 episodes of breakthrough pain within a 3 week period. The primary measure of effectiveness was differences in pain intensity (measured on an 11-point scale) from baseline to the 60-minute period following treatment. Secondary measures included pain relief, time to meaningful pain relief, use of supplemental breakthrough pain medication, and adverse effects. The primary result of pain improvement during the first hour strongly favored FBT (p < 0.0001) compared with placebo. Of the secondary measures that showed significant results, pain intensity differences and pain relief were evident as early as 10 minutes with FBT. Furthermore, significant improvements in pain intensity scores were seen with FBT versus placebo from 15 minutes post-treatment through the 2 hour post-treatment point (65% vs. 28%, p < 0.0001). Patients in the placebo group were 4 times more likely than those in the treatment group to request supplemental opioids for breakthrough pain. Adverse effects that are typical with opioid therapy were more frequent during the dose-titration phase. While 34% of patients experienced adverse events, only 1 withdrew from treatment. Practice Perspectives: One of the key benefits of using FBT appears to be its rapid onset of action, but researchers emphasize the need for patient education on the potential dangers of inappropriate use. One accidental overdose that resulted in loss of consciousness was reported in this study. The researchers stated that the study population was comprised of pain-clinic patients who were opioid-tolerant and may not be representative of the general noncancer pain population. Future studies comparing FBT efficacy against other drugs were suggested. Safety Note: FBT is currently FDA-approved and indicated for the management of breakthrough pain in patients with cancer who are already receiving and tolerant to opioid therapy for their underlying persistent cancer pain. See the package insert for more details. Reference: Portenoy RK, Messina J, Xie F, Peppin J. Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebo-controlled study. Curr Med Res Opin. 2007(Jan);23(1):223-233. < Back to Top > Bone Tumor Pain Relieved by Radiofrequency AblationThe osteoid osteoma is a relatively rare, small, benign tumor that can cause debilitating pain and tends to form in children, adolescents, and young adults. This bone-forming tumor usually occurs in the long bones of the legs, but can appear in other skeletal locations. While osteoid osteoma usually disappears in time without treatment, the tumors have traditionally been removed surgically if pain becomes severe. Results of radiofrequency ablation to relieve this type of bone pain were reported at the Society of Interventional Radiology Annual Meeting in March 2007. A total of 26 patients from a single medical center were treated with CT-guided radiofrequency ablation (RFA) to relieve the pain of symptomatic osteoid osteomas. In this procedure, a probe is guided by computed tomography imaging and inserted through soft tissue to heat the tumor to a temperature of 80 to 90 degrees Celsius. More than half of the patients received general anesthesia, while the others had epidural anesthesia or a combination of general anesthesia and nerve block. In the 22 patients who were evaluated (4 were lost to follow-up), 19 experienced immediate pain relief while 3 patients had no significant reduction in pain. Of the 3 patients without pain relief, one elected to have a repeat RFA treatment that resulted in immediate and complete resolution of pain. Follow-up times varied from 1 day to 1 year, and 20 patients remained pain-free at their respective clinical follow-up evaluation. No complications were reported during or after the procedure and patients could resume normal activities almost immediately. Clinical Implications: The researcher acknowledged that this small study was not comparative, but stated that results were “immediate and permanent” without any post-procedure down time. While all patients had a clinical follow-up, only 8 patients returned for a post-procedure MRI; the investigator stated that he presumed that those who did not return were no longer in any discomfort. In a related news commentary, Robert Vogelzang, MD, from Northwestern Memorial Hospital in Chicago, stated that this is an important confirmation study supporting the positive outcomes for RFA that were reported previously in a similar population. This pain-relieving procedure appears to be a safe and effective alternative to surgery, or to long-term analgesic drug use. Source: Hayeems EB. Radiofrequency ablation of osteoid osteomas: technical, clinical and imaging outcomes. Society of Interventional Radiology 32nd Annual Meeting. Seattle, WA. March 1-6, 2007 Abstract #96. < Back to Top > Trauma, PTSD Affect Chronic Pelvic Pain in WomenMany women do not respond well to treatment for chronic pelvic pain, usually defined as non-cyclic pain that lasts 6 months or longer. This retrospective study gathered data on 713 women to identify the association between a history that includes trauma, abuse, and positive screening for posttraumatic stress disorder (PTSD) with health status and physical symptoms. Participants from one university pain clinic who had chronic pelvic pain that was severe enough to require medical care or cause disability were asked to complete a survey questionnaire to assess those factors. Demographic data showed that 85% of participants were between 18 and 45 years of age and almost half had a college degree or higher. The ethnic distribution showed that 78% were white, while African American and other racial groups represented 16% and 6% of participants, respectively. The investigators found that 47% reported having either a sexual or physical abuse history, and 31% had a positive screen for PTSD. Using regression analysis, controlling for demographic variables, they found that a trauma history was associated with significantly worse daily physical functioning due to poor health, more medical symptoms, more lifetime surgeries, more days spent in bed, and more dysfunction due to pain. Furthermore, a positive screen for PTSD was highly related to most measures of poor health status and somewhat explained the trauma-related poor health status. Practice Perspectives: Based on the results of this survey, the researchers state that a comprehensive evaluation of women with chronic pelvic pain should include a history of abuse and trauma as well as an assessment for PTSD. They believe that the psychiatric comorbidity could contribute to the patient’s perception of the pain, as well as their ability to cope with the symptoms. Since treatment interventions exist for PTSD, it is important to identify the patients for whom post-traumatic therapy could improve the overall results of treatment for pain. Reference: Meltzer-Brody S, Leserman J, Zolnoun D, et al. Trauma and posttraumatic stress disorder in women with chronic pelvic pain. Obstet Gynecol. 2007(Apr);109(4):902-908. < Back to Top > Hydromorphone in UDT May Show Morphine ComplianceUrine drug tests (UDT) are used to determine opioid therapy compliance as well as aberrant drug behavior. The results of a retrospective study to identify the prevalence of hydromorphone in the UDT of patients taking morphine were presented at the American Academy of Pain Medicine Annual Meeting in February 2007. Gas chromatography-mass spectroscopy (GCMS), which is highly accurate for detecting the presence of specific opioid compounds, was used to identify the opioid levels of morphine and hydromorphone. Of those patients taking only morphine (n=32), hydromorphone was identified as being present in 21 cases (66%). Tests positive for hydromorphone were typical of higher daily morphine consumption (mean 151mg +/- 65 mg) and higher urine morphine concentrations. In addition, females were significantly more likely to test positive for hydromorphone and had higher urine concentrations than males (p < 0.05), even if the daily doses of morphine were lower. Clinical Implication: In the past, the presence of hydromorphone in patients prescribed morphine was sometimes considered evidence of unauthorized opioid use. However, the researchers concluded that hydromorphone is a minor metabolite of morphine and, therefore, a compound that could normally appear in urine drug tests of patients on morphine therapy. Rather than indicating aberrant drug behavior, it may demonstrate compliance with morphine therapy. Source: Wasan AD, Michna E, Janfaza D, et al. Interpreting urine drug tests: prevalence of morphine metabolism to hydromorphone in chronic pain patients treated with morphine. American Academy of Pain Medicine 23rd Annual Meeting. New Orleans, LA. February 7-10, 2007. Abstract #152. < Back to Top > Recent Drug and Device Approvals and AnnouncementsFollowing are briefs on new pain-management drug or device approvals as well as items related to safety concerns for existing products. If the FDA news website posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers. Ergotamine tartrate – Headache Relievers Containing Drug to be Discontinued DepoDur® (morphine sulfate extended-release liposome injection) – FDA Caution Renew® Neurostimulation System – FDA Approves New Paddle Leads
Kadian® (Morphine Sulfate) – New 200 mg Strength Approved
Humira™(adalimumab) – Approved for Symptoms of Crohn’s Disease Zelnorm® (tegaserod maleate) – Cardiovascular Events Prompt Discontinuation < Back to Top >
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Unexplained wrist pain is common and it can be challenging to diagnose. A research study published in the April issue of the American Journal of Hand Surgery reports on the results of an analysis of the usefulness of an “Ulnar Fovea Sign” in diagnosing 2 different painful ulnar-sided wrist conditions. A positive sign was represented by successful replication of the patient’s pain upon clinician’s thumb-pressure examination of the soft tissue at the junction of the ulnar bone and the hand.
A PDF of the guidelines is available for download at the ASA website: