Kristyn Zrenda, DO Colony Fugate, DO Amanda Foster, DO ANSWER SUMMARY OF EVIDENCE CRITERIA ACKNOWLEDGEMENTS § In America, prescription opioid deaths secondary to overdose have more than quadrupled between 1999 and 2015 (2,9) § Misused in persons 12 years or older more than any other drug of abuse except marijuana in 2012 (4) § Six out of ten drug overdose deaths involve opioids (2) § Opioid overdose deaths: 91 Americans per day (2) § Overprescribing and prescribing prior to first-line agents in scenarios including headaches (3) § 46% adolescents with headache receive opioids with 29% receiving 3 or more prescriptions (3) § Increase in accidental and intentional pediatric exposure with 21,928 pediatric emergency visits between 2006-2012 due to opioid poisonings; this incidence continues to increase (10) § 62% of those poisonings were unintentional, 11 children died, and 39 required mechanical ventilation (10) § Adolescents are a high risk population: one in four high school seniors have been exposed and one in five misuse opioids (4) § 58% of adolescents who misuse progress to addiction, 42% to abuse, and of those who abuse 16% progress to heroin abuse (4) § Adolescents discordantly report opioid use (5) § First line management for chronic low back pain consists of acetaminophen and non-steroidal anti-inflammatory drugs with secondary medications including tramadol and opioids (11) § Adjunct therapies include spinal manipulation (OMM/OMT or chiropractic), acupuncture, exercise therapy, massage, behavioral therapy, and multidisciplinary rehabilitation (11) § Few high quality trials specifically regarding opioids for chronic pain have discussed efficacy and potential risks (tolerance, hyperalgesia, allodynia) which can lead to higher doses and more frequent use leading to misuse and abuse (11) § Spinal manipulation has been shown to provide relief of back pain, improve psychological well-being, and increase functioning (11) § In 1999, Andersson et al. compared OMM/OMT with standard therapies (analgesics, anti-inflammatory medications, active physical therapy, or therapies such as ultrasonography) in a randomized, controlled study in patients with back pain lasting 3 weeks to 6 months (6) § Using multiple evaluations, the study showed improvement in pain with both OMM/OMT and standard therapies without statistical significance (6) § Secondary outcomes (less medication use) were significantly less in the OMM/OMT group (p<0.001) (6) § OSTEOPATHIC Trial evaluated 455 participants’ short term relief of low back pain with OMM/OMT versus ultrasound therapy using IMMPACT recommendations (8,12) § OMM/OMT versus sham OMM/OMT showed moderate to substantial improvement in low back pain (P<0.001); no statistical significance between ultrasound therapy and sham ultrasound therapy (8) § OMM/OMT was found to be efficacious in reduction of pain perception while ultrasound therapy was not and OMM/ OMT resulted in less pain medication use (p<0.048) (8) § Additional Licciardone et al. study looked at outcomes of OMM/OMT on chronic low back pain according to baseline pain severity on review of the OSTEOPATHIC Trial (7) § Greater than 50% reduction in pain perception was noted in 51% of low baseline pain participants and 41% high baseline pain participants with OMM/OMT (7) § Use of prescription pain medications was also significantly reduced with OMM/OMT compared to other modalities (7) Literature suggestions that OMM/OMT is a possible efficacious adjunctive therapy in the management of chronic pain. Evidence also suggests that use of OMM/OMT can decrease the use of opioid analgesics in the management of chronic pain; which thereby may decrease detrimental outcomes (misuse, abuse, addiction, deaths from opioid overdose, intentional overdoses in adolescents, and unintentional overdoses in children) of our nation’s opioid epidemic. Search Terms: osteopathic, manipulation, chronic pain, opioid Inclusion Criteria: Retrospective, randomized, controlled, cross-sectional, and blinded cohort studies published after 1998 regarding the topic as well as current guidelines in chronic pain management and opioid epidemic data. Exclusion Criteria: Non-English language articles Research thus far has shown concerning statistics regarding the opioid epidemic in the United States with increased rates of misuse, abuse, addition, opioid overdose deaths, adolescent intentional overdoses, and pediatric unintentional overdoses. There are multiple adjunctive therapies available in the management of chronic pain; which is a major cause for opioid use and prescribing. One adjunct therapy with some evidence of efficacy is OMM/OMT. While studies have shown benefits in the management of chronic pain with OMM/OMT, further research is needed, specifically high- quality research, as to the efficacy and longevity of management with OMM/OMT for chronic pain as well as its role in decreasing use, misuse, and abuse of opioid analgesics. SUMMARY OF ISSUES CONCLUSION Misuse defined • “use of a psychotropic medication without a prescription” or • “in greater amounts, more often, or longer than prescribed” (9) CLINICAL QUESTION In an era of opioid misuse and abuse, is osteopathic manipulative medicine (OMM, also known as osteopathic manipulative treatment or therapy, OMT) a possible alternative adjunctive therapy for standard therapies in place of opioid medications in the management of chronic pain to reduce the detrimental outcomes in both adults and children? B level of evidence Defined: Consistent level 2 or 3 studies or extrapolations from level 1 studies (1) LEVEL OF EVIDENCE 1. Welborn, MD, MPH., McCarthy, MLIS. Clin-IQ Preparation Toolkit. Osctr.ouhsc.edu. 2014. Available at: http://osctr.ouhsc.edu/sites/default/files/Clin-IQ%20Toolkit%20%207-21-14.pdf. Accessed December 28, 2017. 2. Center for Disease Control and Prevention (Ed.). (2017, August 30). Understanding the Epidemic. Retrieved December 28, 2017, from https://www.cdc.gov/drugoverdose/epidemic/ index.html 3. DeVries A, et al. Opioid Use Among Adolescent Patients Treated for Headache. Journal of Adolescent Health. 2014;55(1):128-133. doi: 10.1016/j.jadohealth.2013.12.014. 4. Vosburg S, et al. Prescription Opioid Abuse, Prescription Opioid Addiction, and Heroin Abuse Among Adolescents in a Recovery High School: A Pilot Study. J Child Adolesc Subst Abuse. 2015;25(2):105-112. doi:10.1080/1067828x.2014.918005. 5. Palamar J, et al. Discordant reporting of nonmedical opioid use in a nationally representative sample of US high school seniors. Am J Drug Alcohol Abuse. 2016;42(5):530-538. 6. Andersson, G. B., MD, PhD et al (1999). A Comparison of Osteopathic Spinal Manipulation with Standard Care for Patients with Low Back Pain. The New England Journal of Medicine, 341(19), 1426-1431. doi:10.1056/NEJM199911043411903 7. Licciardone J, Kearns C, Minotti D. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: Results from the OSTEOPATHIC Trial. Man Ther. 2013;18(6):533-540. doi:10.1016/j.math.2013.05.006. 8. Licciardone J, Minotti D, et al. Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain: A Randomized Controlled Trial. The Annals of Family Medicine. 2013;11(2):122-129. doi:10.1370/afm.1468. 9. Han B, et al. Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults: 2015 National Survey on Drug Use and Health. Ann Intern Med. 2017;167(5):293. doi:10.7326/m17-0865. 10. Tadros A, et al. Emergency department visits by pediatric patients for poisoning by prescription opioids. Am J Drug Alcohol Abuse. 2016;42(5):550-555. doi: 10.1080/00952990.2016.1194851. 11. Last, A. R., MD, PhD, MPH, et al (2009). Chronic Low Back Pain: Evaluation and Management. American Family Physician, 79(12), 10671074. Retrieved from https://www.aafp.org/afp/ 2009/0615/p1067.html 12. McGrath P, et al. Core Outcome Domains and Measures for Pediatric Acute and Chronic/Recurrent Pain Clinical Trials: PedIMMPACT Recommendations. The Journal of Pain. 2008;9(9): 771-783. doi:10.1016/j.jpain.2008.04.007.
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KristynZrenda,DO ColonyFugate,DO AmandaFoster,DO
ANSWER
SUMMARY OF EVIDENCE
CRITERIA
ACKNOWLEDGEMENTS
§ InAmerica,prescriptionopioiddeathssecondarytooverdosehavemorethanquadrupledbetween1999and2015(2,9)
§ Misusedinpersons12yearsoroldermorethananyotherdrugofabuseexceptmarijuanain2012(4)
§ Sixoutoftendrugoverdosedeathsinvolveopioids(2)§ Opioidoverdosedeaths:91Americansperday(2)§ Overprescribingandprescribingpriortofirst-lineagentsin
scenariosincludingheadaches(3)§ 46%adolescentswithheadachereceiveopioidswith29%
receiving3ormoreprescriptions(3)§ Increaseinaccidentalandintentionalpediatricexposurewith
21,928pediatricemergencyvisitsbetween2006-2012duetoopioidpoisonings;thisincidencecontinuestoincrease(10)
§ 62%ofthosepoisoningswereunintentional,11childrendied,and39requiredmechanicalventilation(10)
§ Adolescentsareahighriskpopulation:oneinfourhighschoolseniorshavebeenexposedandoneinfivemisuseopioids(4)
§ 58%ofadolescentswhomisuseprogresstoaddiction,42%toabuse,andofthosewhoabuse16%progresstoheroinabuse(4)
§ Adolescentsdiscordantlyreportopioiduse(5)
§ Firstlinemanagementforchroniclowbackpainconsistsofacetaminophenandnon-steroidalanti-inflammatorydrugswithsecondarymedicationsincludingtramadolandopioids(11)
§ Adjuncttherapiesincludespinalmanipulation(OMM/OMTorchiropractic),acupuncture,exercisetherapy,massage,behavioraltherapy,andmultidisciplinaryrehabilitation(11)
§ Fewhighqualitytrialsspecificallyregardingopioidsforchronicpainhavediscussedefficacyandpotentialrisks(tolerance,hyperalgesia,allodynia)whichcanleadtohigherdosesandmorefrequentuseleadingtomisuseandabuse(11)
§ Spinalmanipulationhasbeenshowntoprovidereliefofbackpain,improvepsychologicalwell-being,andincreasefunctioning(11)
§ In1999,Anderssonetal.comparedOMM/OMTwithstandardtherapies(analgesics,anti-inflammatorymedications,activephysicaltherapy,ortherapiessuchasultrasonography)inarandomized,controlledstudyinpatientswithbackpainlasting3weeksto6months(6)
§ Usingmultipleevaluations,thestudyshowedimprovementinpainwithbothOMM/OMTandstandardtherapieswithoutstatisticalsignificance(6)
§ Secondaryoutcomes(lessmedicationuse)weresignificantlylessintheOMM/OMTgroup(p<0.001)(6)
§ OSTEOPATHICTrialevaluated455participants’shorttermreliefoflowbackpainwithOMM/OMTversusultrasoundtherapyusingIMMPACTrecommendations(8,12)
§ OMM/OMTversusshamOMM/OMTshowedmoderatetosubstantialimprovementinlowbackpain(P<0.001);nostatisticalsignificancebetweenultrasoundtherapyandshamultrasoundtherapy(8)
§ OMM/OMTwasfoundtobeefficaciousinreductionofpainperceptionwhileultrasoundtherapywasnotandOMM/OMTresultedinlesspainmedicationuse(p<0.048)(8)
§ AdditionalLicciardoneetal.studylookedatoutcomesofOMM/OMTonchroniclowbackpainaccordingtobaselinepainseverityonreviewoftheOSTEOPATHICTrial(7)
§ Greaterthan50%reductioninpainperceptionwasnotedin51%oflowbaselinepainparticipantsand41%highbaselinepainparticipantswithOMM/OMT(7)
§ UseofprescriptionpainmedicationswasalsosignificantlyreducedwithOMM/OMTcomparedtoothermodalities(7)
LiteraturesuggestionsthatOMM/OMTisapossibleefficaciousadjunctivetherapyinthemanagementofchronicpain.EvidencealsosuggeststhatuseofOMM/OMTcandecreasetheuseofopioidanalgesicsinthemanagementofchronicpain;whichtherebymaydecreasedetrimentaloutcomes(misuse,abuse,addiction,deathsfromopioidoverdose,intentionaloverdosesinadolescents,andunintentionaloverdosesinchildren)ofournation’sopioidepidemic.
SearchTerms:osteopathic,manipulation,chronicpain,opioidInclusionCriteria:Retrospective,randomized,controlled,cross-sectional,andblindedcohortstudiespublishedafter1998regardingthetopicaswellascurrentguidelinesinchronicpainmanagementandopioidepidemicdata.ExclusionCriteria:Non-Englishlanguagearticles
ResearchthusfarhasshownconcerningstatisticsregardingtheopioidepidemicintheUnitedStateswithincreasedratesofmisuse,abuse,addition,opioidoverdosedeaths,adolescentintentionaloverdoses,andpediatricunintentionaloverdoses.Therearemultipleadjunctivetherapiesavailableinthemanagementofchronicpain;whichisamajorcauseforopioiduseandprescribing.OneadjuncttherapywithsomeevidenceofefficacyisOMM/OMT.WhilestudieshaveshownbenefitsinthemanagementofchronicpainwithOMM/OMT,furtherresearchisneeded,specificallyhigh-qualityresearch,astotheefficacyandlongevityofmanagementwithOMM/OMTforchronicpainaswellasitsroleindecreasinguse,misuse,andabuseofopioidanalgesics.
SUMMARY OF ISSUES
CONCLUSION
Misusedefined• “useofapsychotropicmedicationwithoutaprescription”or• “ingreateramounts,moreoften,orlongerthanprescribed”(9)
CLINICAL QUESTION Inaneraofopioidmisuseandabuse,isosteopathicmanipulativemedicine(OMM,alsoknownasosteopathicmanipulativetreatmentortherapy,OMT)apossiblealternativeadjunctivetherapyforstandardtherapiesinplaceofopioidmedicationsinthemanagementofchronicpaintoreducethedetrimentaloutcomesinbothadultsandchildren?
BlevelofevidenceDefined:Consistentlevel2or3studiesorextrapolationsfromlevel1studies(1)
LEVEL OF EVIDENCE
1. Welborn,MD,MPH.,McCarthy,MLIS.Clin-IQPreparationToolkit.Osctr.ouhsc.edu.2014.Availableat:http://osctr.ouhsc.edu/sites/default/files/Clin-IQ%20Toolkit%20%207-21-14.pdf.AccessedDecember28,2017.
2. Center forDiseaseControlandPrevention (Ed.). (2017,August30).UnderstandingtheEpidemic.RetrievedDecember28,2017, fromhttps://www.cdc.gov/drugoverdose/epidemic/index.html
3. DeVriesA,etal.OpioidUseAmongAdolescentPatientsTreatedforHeadache.JournalofAdolescentHealth.2014;55(1):128-133.doi:10.1016/j.jadohealth.2013.12.014.4. VosburgS,etal.PrescriptionOpioidAbuse,PrescriptionOpioidAddiction,andHeroinAbuseAmongAdolescentsinaRecoveryHighSchool:APilotStudy.JChildAdolescSubstAbuse.
2015;25(2):105-112.doi:10.1080/1067828x.2014.918005.5. PalamarJ,etal.DiscordantreportingofnonmedicalopioiduseinanationallyrepresentativesampleofUShighschoolseniors.AmJDrugAlcoholAbuse.2016;42(5):530-538.6. Andersson,G.B.,MD,PhDetal(1999).AComparisonofOsteopathicSpinalManipulationwithStandardCareforPatientswithLowBackPain.TheNewEnglandJournalofMedicine,
341(19),1426-1431.doi:10.1056/NEJM199911043411903
7. LicciardoneJ,KearnsC,MinottiD.Outcomesofosteopathicmanualtreatmentforchroniclowbackpainaccordingtobaselinepainseverity:ResultsfromtheOSTEOPATHICTrial.ManTher.2013;18(6):533-540.doi:10.1016/j.math.2013.05.006.
8. Licciardone J,Minotti D, et al.OsteopathicManual Treatment andUltrasound Therapy for Chronic LowBack Pain: A Randomized Controlled Trial.TheAnnals of FamilyMedicine.2013;11(2):122-129.doi:10.1370/afm.1468.
9. HanB,etal.PrescriptionOpioidUse,Misuse,andUseDisordersinU.S.Adults:2015NationalSurveyonDrugUseandHealth.AnnInternMed.2017;167(5):293.doi:10.7326/m17-0865.10. Tadros A, et al. Emergency department visits by pediatric patients for poisoning by prescription opioids. Am J Drug Alcohol Abuse. 2016;42(5):550-555. doi:
10.1080/00952990.2016.1194851.11. Last,A.R.,MD,PhD,MPH,etal(2009).ChronicLowBackPain:EvaluationandManagement.AmericanFamilyPhysician,79(12),10671074.Retrievedfromhttps://www.aafp.org/afp/
2009/0615/p1067.html12. McGrathP,etal.CoreOutcomeDomainsandMeasuresforPediatricAcuteandChronic/RecurrentPainClinicalTrials:PedIMMPACTRecommendations.TheJournalofPain.2008;9(9):
771-783.doi:10.1016/j.jpain.2008.04.007.
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