Pharmacological Management of Persistent Pain in Older Persons: Focus on Opioids and Nonopioids

The Journal of Pain, Vol 12, No 3 (March), Suppl. 1, 2011: pp S14-S20 Available online at www.sciencedirect.com

Pharmacological Management of Persistent Pain in Older Persons: Focus on Opioids and Nonopioids F. Michael Gloth III Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, and University of Maryland School of Epidemiology and Preventive Medicine, Baltimore, Maryland.

Abstract: Managing persistent pain is challenging, particularly in older adults who often have comorbidities and physiological changes that affect dosing and adverse effect profiles. The latest guideline issued by the American Geriatrics Society in 2009 is an important clinical resource on prescribing analgesics for older adults. This guideline helps form an evidence-based approach to treating persistent pain, along with other current endorsements, such as the relevant disease-specific recommendations by the American College of Rheumatology, the European League Against Rheumatism, and Osteoarthritis Research Society International, as well as opioid-specific guidelines issued by the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards of the United States, and the American Society of Interventional Pain Physicians. Safety is of utmost concern, especially for older adults; these guidelines include key approaches for safe opioid prescribing. Combining analgesics that have multiple mechanisms of action with nonpharmaceutical approaches can be beneficial in providing pain relief. Nontraditional analgesics are also considered on a case-by-case basis, and a few of these options are weakly recommended. Therapies should be initiated at the lowest possible dose and slowly titrated to effect, while tailoring them to the therapeutic and side-effect responses of the individual. Perspective: For treating persistent pain in older adults, acetaminophen and opioids are important therapies in the analgesic armamentarium. In contrast, oral nonselective and selective NSAIDs should rarely be used. All patients with neuropathic pain are candidates for treatment with adjuvant analgesics; those with localized neuropathic pain can benefit from topical lidocaine. ª 2011 by the American Pain Society Key words: Guidelines, persistent pain, recommendations, treatment, analgesics.

T

he 2009 American Geriatrics Society (AGS) guidelines on pharmacological treatment of persistent pain in older adults revised some of the previous AGS recommendations,1,2,4 and was an important addition to the opioid-specific 2009 guidelines issued by the American Pain Society (APS) and American Academy of Pain Medicine (AAPM).11 The evidence in the litGrants/research support from Merck and HCR-Manor Care; Consulting fees from CDC, American College of Rheumatology, Novartis, Endo Pharmaceuticals Inc., American Geriatrics Society, Merck, HCR-Manor Care, Genentech, Amgen, Purdue, and Pfizer; Speaker’s bureau from Novartis, Genentech, Purdue, Amgen, Endo Pharmaceuticals Inc., Merck, MER, American Geriatrics Society; Ownership interest/shareholder: Smart E-Records, Allscripts; Royalty/patent holder: Humana Press (Springer); Royalties: DiaMedica Publishing; Royalty contract: Smart E-Records. An educational grant was provided by Endo Pharmaceuticals Inc. for the symposium on which this paper was based and for subsequent manuscript development. Publication of this article was supported by Endo Pharmaceuticals Inc. Address reprint requests to Dr. F. Michael Gloth III, 5505 Hopkins Bayview Circle, Baltimore, MD 21224. E-mail: [email protected] 1526-5900/$36.00 ª 2011 by the American Pain Society doi:10.1016/j.jpain.2010.11.006

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erature was considered and classified based on its quality and strength, using a modified version of the system that the American College of Physicians developed for creating guidelines, called the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). The AGS recommendations were then formulated and graded in intensity (eg, strong or weak) based on the quality of the data and the practicality of the recommendations (eg, the availability of alternative treatments). The AGS made strong recommendations in cases where either the risks or benefits of using a pharmacotherapy clearly outweighed the other, whereas weak recommendations were given in unclear circumstances wherein the benefits were balanced by approximately equal risks.4

Nonopioid Analgesics Acetaminophen remains the first-line treatment recommended by the AGS for treating persistent mild pain in older adults.4 This is supported by high-quality

Gloth III evidence and is a strong recommendation. In particular, acetaminophen should be the initial approach to managing musculoskeletal pain, such as osteoarthritis and low back pain (LBP). Guidelines developed by the American College of Rheumatology, the European League Against Rheumatism (EULAR), and Osteoarthritis Research Society International (OARSI) concur that the initial treatment of osteoarthritis pain should be with acetaminophen.3,21,22 New data from patients taking long-term acetaminophen treatment indicate that transient elevations in the liver enzyme alanine aminotransferase do not translate into liver failure or hepatic dysfunction when the maximum recommended doses are not exceeded.4 However, acetaminophen is less effective for treating inflammatory conditions. Furthermore, high-quality evidence supports the presence of liver failure as an absolute contraindication for taking acetaminophen, while the AGS strongly recommends a cautious approach and a relative contraindication for using this nonopioid in patients with hepatic insufficiency or chronic alcohol abuse or dependence. Additionally, a strong recommendation of the AGS, although supported by only moderate evidence, is adherence to maximum daily dosage limitations for acetaminophen: <4 g/day from all sources.4 Nonsteroidal anti-inflammatory drugs (NSAIDs) pose a much greater risk for causing adverse events within older adult populations.4 Hence, most NSAIDs, particularly oral formulations, should rarely be considered for select older adults on an individual basis (Table 1).4,5 Extra caution must be exercised with NSAIDs in older adults with reduced creatinine clearance, gastropathy, cardiovascular disease, or intravascularly depleted states such as congestive heart failure.4 The risks of gastrointestinal effects with NSAID use are well established, but are further escalated when they are taken with lowdose aspirin—a commonly employed strategy for cardioprotective purposes. Even cyclooxygenase-2 (COX-2) selective inhibitors increase the risk for gastrointestinal adverse effects. Hence, older adults should be coprescribed a proton pump inhibitor or another gastroprotective agent when taking COX-2 medications for an extended period.4 Furthermore, because of the risk of cardiovascular adverse events, most oral NSAIDs should be avoided in older adults, with the possible exception of naproxen. Naproxen may have a comparatively lower risk of cardiovascular events, although all the other typical NSAID adverse effects are not lessened in risk.4 Although topical NSAIDs have the same class adverse effect profile as oral NSAIDs, the risk of developing them seems to be reduced, although long-term studies are needed.4 Indeed, the 2008 guidelines endorsed by the American College of Rheumatology as well as OARSI recommend the use of topical NSAIDs as adjuncts or alternative therapies to oral analgesics.3,22 Overall high-quality evidence indicates that for older individuals, both nonselective NSAIDs and COX-2 selective inhibiting agents should only be considered with extreme caution in rare circumstances, and in carefully selected individuals.4 For older patients who have not

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benefited from other, safer analgesic therapies, NSAIDs can be prescribed if the patient continues to meet therapeutic goals during ongoing assessments, and the benefits of NSAID therapy outweigh the risks and complications. Although the evidence concerning the continuing monitoring of adverse effects is weak, with very limited data available from older adult populations, the AGS strongly recommends close observation for the development of side effects.4 The AGS strongly recommends that persons with active peptic ulcer disease (based on low-quality evidence) and chronic kidney disease (based on moderate-quality evidence) are contraindicated from taking NSAIDs, while moderate evidence and a weak recommendation from the AGS suggests that persons with heart failure are contraindicated.4 Furthermore, based on moderate-quality evidence, the AGS strongly recommends that relative caution should be exercised for persons with hypertension, Helicobacter pylori infections, a history of peptic ulcer disease, and concomitant use of steroids or selective serotonin reuptake inhibitors (SSRIs).4 High-quality data from older adult populations support strong recommendations for coprescribing a proton pump inhibitor, high-dose H2-receptor antagonist, or misoprostol to provide gastroprotection for older persons taking nonselective NSAIDs or a COX-2 selective inhibitor with aspirin.4 Although supported only by low-quality evidence, the AGS strongly recommends that older persons should not take more than 1 NSAID (selective or nonselective) for pain control; NSAIDs should not be combined. The AGS only weakly recommends that older adults taking aspirin for cardiovascular prophylaxis should not take ibuprofen, as moderate-quality evidence suggests that ibuprofen interferes with the cardioprotective advantage conferred by aspirin.4 There are alternatives available for pain control in this circumstance. The guidelines strongly support routine evaluation specifically focusing on gastrointestinal and renal toxicity, hypertension, heart failure, and other drug-drug or drug-disease interactions for all older patients taking nonselective NSAIDs and COX-2 selective inhibitors.

Opioids Both the AGS and a panel assembled by the APS and AAPM in 2009 have recommended the use of opioids for treatment of persistent pain in carefully selected and monitored patients.4,11 Still, the evidence supporting the long-term effectiveness of opioids for treating persistent noncancer pain conditions is lacking for all age groups,10 but particularly for older adults.4 Hence, this has limited the strength of some of the recommendations of the AGS for prescribing opioids. Furthermore, the analysis of the clinical trial data in support of opioid therapy for long-term persistent pain management was complicated by the study populations, which often lacked frail participants and adults with comorbid conditions. Because of these limitations, some positive data from younger adult populations could not be translated to recommendations for older adults.

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Management of Persistent Pain in Older Persons

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Table 1.

Commonly Used Analgesics That Should Be Avoided in Older Adults14

MEDICATION

DOCUMENTED CONCERNS

ADVERSE OUTCOME SEVERITY

Low efficacy Side effects Falls risk Toxicity Side effects Toxicity

Low severity

Indomethacin

Side effects Drug interactions

High severity

Ketorolac

Side effects

High severity

Pentazocine

Side effects

High severity

Amitriptyline

Side effects Toxicity Low efficacy Side effects Toxicity Drug interactions

High severity

Propoxyphene

Meperidine

NSAIDs COX-2 inhibitors

High severity

High severity

ADDITIONAL COMMENT Often combined with high acetaminophen doses. No stronger than aspirin. Links to falls, psychomimetic effects, and nerve and cardiac toxicity (no longer approved for use in the US) Dosage of 600 mg/d or when used for >48 hours increases risk of neurotoxicity-induced seizures. Tremulousness, dysphoria, and myoclonus. Potentially fatal drug interactions (monoamine oxidase inhibitor) High risk of upper GI bleed and perforation. Many fatal events involving older adults. Risk increases with age Risk of GI bleed 4-fold more than ibuprofen. Increased risk with age and incrementally with each day of use Age increases risk of CNS excitation, hallucinations, confusion, and agitation Anticholinergic effects, cognitive impairment GI bleeding and perforation. Effect on bleeding/ clotting. Potential cardiovascular, renal, and/or skin toxicity

Abbreviations: CNS, central nervous system; COX, cyclooxygenase; GI, gastrointestinal; NSAID, nonsteroidal anti-inflammatory drug. NOTE. Adapted from Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH: Updating the Beers criteria for potentially inappropriate medication use in older adults: Results of a US consensus panel of experts. Arch Intern Med 163:2716-2724, 2003.

Similar to the recommendations by the APS and AAPM on prescribing opioids for adults of all ages with persistent noncancer pain,11 the AGS made recommendations for older patients based upon the potential efficacy and risks compared with other modalities, balanced against the harms of unrelieved pain and potential adverse effects of opioid therapy.4 Toward that end, the AGS expert panel suggested that 2 sets of questions should be considered in order to determine whether a trial of opioid therapy should be pursued for treating older patients with moderate to severe pain. Regarding the patient: 1. What is conventional practice for this type of pain or pain patient? 2. Is there an alternative therapy that is likely to have an equivalent or better therapeutic index for pain control, functional restoration, and improvement in quality of life? 3. Does the patient have medical problems that may increase the risk of opioid-related adverse effects? 4. Is the patient likely to manage the opioid therapy responsibly (or relevant caregiver likely to responsibly comanage)? Regarding the practitioner/organization: 1. Am I able to treat this patient without help? 2. Do I need the help of a pain specialist or other consultant to comanage this patient? 3. Are there appropriate specialists and resources available to help me comanage this patient?

4. Are the patient’s medical, behavioral, or social circumstances so complex as to warrant referral to a pain medicine specialist for treatment? Having taken those considerations into account, it is wise to realize that, despite an exceedingly low risk of opioid abuse/misuse by older patients with no current or past history of substance abuse, it is not possible to identify every individual who will abuse or divert prescribed opioids.4 Hence, when approaching pain management with any patient, including older adults, a universal precautions approach is prudent. In particular, this includes considering the possibility that opioids can be diverted and taking appropriate steps to circumvent that, such as appropriate patient selection and risk stratification. Resources toward this end include the prescribing guidelines by the Federation of State Medical Boards of the United States (FSMB.org), the AGS and AAPM, and the American Society of Interventional Pain Physicians (ASIPP).11,13,19 Furthermore, several tools have been developed to screen patients for risk of diversion or substance abuse or to identify current aberrant drug-behavior problems. In particular, the Opioid Risk Tool (ORT) has been found to discriminate with high sensitivity and specificity between individuals who are likely and those who are unlikely to develop aberrant behaviors while taking opioids.20 A review of the available evidence-based literature conducted during the development of the APS and AAPM 2009 clinical guidelines identified the Revised

Gloth III Screener and Opioid Assessment for Patients with Pain (SOAPP-R) as a method for assessing risk of opioid misuse or abuse in a candidate for long-term opioid treatment.8,12 According to a review of the literature by the APS and AAPM, high scores on the SOAPP-R were weakly associated with an increased risk for future aberrant drug-related behaviors,12 although new studies have further validated the SOAPP-R in a population taking opioids for chronic, noncancer pain.9 The tool has adequate sensitivity and specificity to be used as a screening device and has established predictive validity and reliability.6,8 Patients can be stratified as a low, medium, or high risk for aberrant behaviors before treatment initiation with either the ORT or SOAPP and then the treatment plan can be tailored accordingly.4 Meanwhile, the Current Opioid Misuse Measure (COMM) can be integrated into clinical practice as a routine component of ongoing treatment intervention to screen for the development of drug misuse. High scores on the COMM have been weakly associated with an increased likelihood of current abuse in a high-quality study that also established the tool’s internal consistency, reliability, and validity.7 To be in compliance with the FSMB Model Policy for the Use of Controlled Substances for the Treatment of Pain, which has been endorsed by the APS, AAPM, Drug Enforcement Administration, and National Association of State Controlled Substances Authorities, a comprehensive evaluation of patients must be documented and a clear treatment plan then developed based on the findings.13 Although not commonly employed with older adults, in some select circumstances, informed consent may be recommended along with cosigning a treatment agreement. If such an agreement is used, it should detail the expectations and parameters for therapy, such as patient completion of urine screenings when asked, the number and frequency of prescription refills, and reasons for discontinuation of therapy.13 Conducting periodic reviews is of paramount importance regardless of the age of the patient, along with keeping complete and up-to-date medical records. Consultation should be pursued when needed. Certainly, it is imperative to comply with all controlled substance laws and regulations. Regarding opioids, the AGS, APS, and AAPM recommend that all patients with moderate-to-severe pain, pain-related functional impairment, or diminished quality of life due to pain should be considered for opioid therapy.4,11 Although there is not a plethora of evidence within older adults to support the statement, it is a strong recommendation from the AGS. The FSMB policy also supports this stance, particularly for adults with refractory pain. Indeed, the FSMB recognizes the undertreatment of pain as a public health issue and stresses that pain management is an integral component of appropriate medical care.13 Weak evidence indicates that patients with frequent or continuous pain on a daily basis should be treated with around-the-clock, time-contingent dosing aimed at achieving a steady state of opioid therapy.4 Additionally, a multidisciplinary, international consensus group noted that in older adults with impaired renal or hepatic

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function, opioids can have extended half-lives; hence, doses should be reduced with the intervals between dosing elongated.18 The AGS did not make specific recommendations regarding which opioid should be chosen; rather, each clinician should make the decision based on each individual’s needs. However, the AGS strongly recommends that the maximal safe doses of acetaminophen or NSAIDs should not be exceeded when using fixed-dose opioid combination agents as part of an analgesic regimen. Combination products are commonly used; thus, a cautious approach is needed in order to stay within safe dose limits. Also, methadone should be initiated and titrated cautiously only by clinicians well versed in its use and risks. Many primary care physicians may need to consult a specialist in order to safely manage older adult patients with methadone. Furthermore, current guidelines compiled by experts in geriatric clinical pharmacy strongly recommend that older adults with a creatinine clearance below 30 mL/min should not be prescribed meperidine or propoxyphene.16 When long-acting opioid preparations are prescribed (Table 2), breakthrough pain should be anticipated and assessed for regularly. Breakthrough pain includes endof-dose failure, wherein steady state blood levels fall below the concentration needed for analgesia; ‘‘incident pain’’ caused by activity; and spontaneous pain, as commonly occurs with painful neuropathies.4 These pains can be prevented and/or treated using short-acting immediate-release opioid medications, supported by both moderate evidence and a strong recommendation by the AGS. Once a therapeutic trial of opioids has been initiated, ongoing monitoring for the safety and efficacy of the therapy is strongly recommended in both the AGS and the APS/AAPM guidelines.4,11 Moderate evidence suggests that patients taking opioid analgesics should be reassessed for ongoing attainment of therapeutic goals, adverse effects, and safe and responsible medication use. The management of pain by opioids entails dose titration for optimization of effects, and possibly involves the need for opioid rotation in order to identify an opioid with an appropriate therapeutic effect combined with tolerability for an individual.11 An interdisciplinary panel with expertise on opioid pharmacology reached consensus regarding guidelines for opioid rotation and published their recommendations in 2009.15 This strategy for addressing an unsatisfactory response to an initially prescribed opioid should involve the calculation of a dose of a new opioid based on the equianalgesic dose table for opioids,17 followed by 2 safety steps. The first is an automatic adjustment in the dose due to the often-understated potency of a new opioid because of incomplete tolerance, while the second is an additional dose adjustment based on the characteristics of the individual and their pain. The first adjustment typically involves a 25 to 50% reduction in the calculated equivalent dose, with the 2 exceptions of methadone, which requires a 75 to 90% reduction, and transdermal fentanyl, which does not require any adjustment (see package insert for equianalgesic dose ratios).15 A 50% reduction in dose may be applied for older adults,

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Management of Persistent Pain in Older Persons

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Table 2.

Currently Available Long-Acting Opioids OPIOID

DOSAGES

Extended-release oral hydromorphone Methadone

Capsules or tablets: 8, 12, 16, 24, 32 mg Tablets: 5, 10 mg

Extended-release oral morphine

Capsules or tablets: 10, 15, 20, 30, 50, 60, 80, 90, 100, 120, 200 mg Tablets: 15, 30, 60, 100 mg Tablets: 10, 15, 20, 30, 40, 60, 80, 160 mg Tablets: 5, 7.5, 10, 15, 20, 30, 40 mg Patches: 12, 25, 50, 75, 100 mg/hr Tablets: 100, 200, 300 mg Patches: 5, 10, 20 mg/hr

Sustained-release oral morphine Controlled-release oral oxycodone Extended-release oral oxymorphone Transdermal fentanyl Extended-release oral tramadol Transdermal buprenorphine

medically frail, patients of non-Caucasian heritage, and when switching from a high-dose opioid, whereas a 25% reduction may be applied when just switching the route of administration of an opioid.15 The second safety step is an additional dose adjustment of 15 to 30% based on the pain severity and the medical and psychosocial characteristics of the patient.15 As noted with the previous AGS guidelines, the adverse effects of opioids are an important consideration when prescribing opioids for older adults.2 Hence, clinicians should anticipate, assess for, and identify potential opioid-associated adverse effects. Although this common sense approach is strongly recommended by the AGS, APS, and AAPM, only a moderate quality of evidence supports this.4,11 Notably, tolerance develops to many opioid symptoms within days of therapy initiation—but not to constipation, even with long-term therapy.18 Since constipation can be particularly problematic for older adults, the 2009 AGS guidelines emphasize that prophylaxis and/or treatment for constipation should be addressed at the outset of long-term opioid therapy, and can include hydration, bulk fiber (only if hydration can be maintained), activity, senna, and sorbitol (20 cc of 70% taken twice daily for 3 days per week). Alternatively, methylnaltrexone has opioid antagonist activity that can be specifically beneficial to treating opioid-induced constipation.

Adjuvant Analgesics Adjuvants are agents that were originally developed for an indication other than pain but were later discovered to provide analgesia. This class includes antidepressants, anticonvulsants, and other agents that target neuronal cell surface proteins, such as ion channels and receptors. Based on high-quality evidence, the AGS strongly recommends that all patients with neuropathic pain are candidates for treatment with adjuvant analgesics, and specifically, those who have fibromyalgia may warrant a trial of an approved adjuvant medication. Lesser evidence supports trying adjuvant analgesics for other types of refractory persistent pain, such as back pain, headache, diffuse bone pain, and temporomandibular disorder. However, the AGS strongly recommends that tertiary tricyclic antidepressants, including amitriptyline, imipramine, and doxepin, should be avoided in older adults due to their

ADMINISTRATION FREQUENCY Once daily Twice or 3 times daily (individualization needed) Once daily Twice daily Twice daily Twice daily Changed once every 72 hours Once daily Changed once weekly

high risk for adverse consequences: anticholinergic effects and cognitive impairment. Also, the consensus recommendations from a geriatric clinical pharmacist expert panel were to reduce the dose of gabapentin when prescribed for pain in patients with renal dysfunction.16 Specifically, patients with a creatinine clearance of 30 to 59 mL/min should have a maximum dose of 600 mg twice daily, 15 to 29 mL/min limited to 300 mg twice daily, and <15 mL/min prescribed no more than 300 mg per day.16 The AGS strongly recommends that although adjunctive agents can be effective in isolation, their benefits can be enhanced when combined with other analgesics and/or nonpharmaceutical approaches.4 Also, when prescribed for older adults, these therapies should be initiated at the lowest possible dose and slowly titrated to effect, while being tailored to the therapeutic and side effect responses of an individual. Certainly, each analgesic considered should be given a trial of adequate length before discontinuation.

Other Drugs Other options beyond traditional analgesics for treating persistent pain are considered less reliable according to the most recent AGS guidelines.4 These include corticosteroids, muscle relaxants, benzodiazepines, calcitonin, bisphosphonates, and topical analgesics. Because of the low-quality evidence available, many nontraditional agents, such as glucosamine, chondroitin, cannabinoids, botulinum toxin, alpha-2 adrenergic agonists, calcitonin, vitamin D, bisphosphonates, and ketamine should only be used cautiously in older persons until further research establishes their safety and efficacy. Additionally, the AGS strongly recommends that long-term systemic corticosteroids should only be used in older adults to treat pain-associated inflammatory disorders or metastatic bone pain; osteoarthritis should not be considered an inflammatory disorder. However, the AGS strongly supports the use of topical lidocaine for treating localized neuropathic pain, and the analgesic is also weakly recommended for localized non-neuropathic pain. The other topical agents with recommendations, although weak, are topical NSAIDs for treatment of localized non-neuropathic persistent pain, and capsaicin or menthol for regional pain syndromes.

Gloth III

Conclusions Acetaminophen remains the first-line recommendation by the AGS among the nonopioid class. Overall, the longterm use of NSAIDs should be infrequently employed in older adults; although, if needed, a topical formulation can be prescribed or, perhaps, oral naproxen can be coprescribed along with an agent for gastrointestinal protection. Opioids are indeed acceptable for older adults. Despite the population’s low risk for addiction, proper precautions should always be implemented when prescribing opioids. The FSMB and other sources have constructed guidance for the appropriate prescribing practices and documentation necessary for managing patients with opioids. Regularly scheduled dosing is necessary for patients with persistent pain, particularly those with cognitive

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dysfunction and/or dementia who are unable to vocalize their need for analgesia. Regular reassessments should be conducted to ensure ongoing pain control and alternative therapies—such as physical therapy, cognitive behavioral therapy, and patient/caregiver education— should be combined with pharmacotherapies in order to optimize functional gains in older patients with persistent pain.4,22 Pharmacotherapies that do not exacerbate comorbid conditions and, if possible, treat multiple issues (such as depression and pain) should be prescribed. Combination pharmacotherapeutic approaches that utilize complementary mechanistic actions or synergism for enhanced effects may be necessary to attain adequate analgesia in patients who have dose-limiting adverse effects.

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Management of Persistent Pain in Older Persons mendations for the management of hip osteoarthritis: Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 64:669-681, 2005 22. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P: OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil 16:137-162, 2008