Noninvasive Nonpharmacological Treatment For Chronic Pain .
Comparative Effectiveness ReviewNumber 227RNoninvasive NonpharmacologicalTreatment for Chronic Pain: ASystematic Review UpdateEvidence SummaryIntroductionThis review focuses on noninvasivenonpharmacological treatment forchronic pain including exercise, mindbody practices, psychological therapies,multidisciplinary rehabilitation,mindfulness practices, manual therapies,physical modalities, and acupuncture, andupdates our prior Agency for HealthcareResearch and Quality (AHRQ) review.1Many trials have examined the impact ofthese interventions on outcomes during orimmediately after the course of treatmentreporting improved function and reducedpain. However, given the persistence ofchronic pain, understanding whether thebenefits are durable would be very helpfulfor informing selection of therapies.Therefore, this report focuses on durabilityof treatment effects, defined as at least 1month following the end of a course oftreatment.Chronic pain substantially impactsphysical and mental functioning,productivity, quality of life, and familyrelationships; it is the leading causeof disability and is often refractory totreatment.2,3 Chronic pain is often definedas pain lasting 3 months or longer orpersisting past the normal time fortissue healing, though definitions vary.2,4Chronic pain affects millions of adultsin the United States, with an annualPurpose of ReviewTo assess noninvasive nonpharmacological treatments for common chronic pain conditions.Key Messages Interventions that improved function and/or pain for 1 month:– Low back pain: Exercise, psychological therapy,spinal manipulation, low-level laser therapy,massage, mindfulness-based stress reduction,yoga, acupuncture, multidisciplinary rehabilitation(MDR)– Neck pain: Exercise, low-level laser, mind-bodypractices, massage, acupuncture– Knee osteoarthritis: Exercise, cognitive behavioraltherapy (CBT)– Hip osteoarthritis: Exercise, manual therapies– Fibromyalgia: Exercise, CBT, myofascial releasemassage, mindfulness practices, tai chi, qigong,acupuncture, MDR– Tension headache: Spinal manipulation Some interventions did not improve function or pain. Serious harms were not observed with theinterventions.
cost in personal and health system expendituresconservatively estimated at 560 billion to 635billion.2 The Centers for Disease Control andPrevention (CDC) estimated that 1 in 5 adultsin the United States experienced chronic painin 2016, with 8 percent reporting high-impactchronic pain that limited life or work activitiesdaily or most days in the previous 6 months.5,6Chronic pain is multifaceted and is influencedby multiple factors (e.g., genetic, central nervoussystem, psychological, and environmental factors)and complex interactions, making pain assessmentand management a challenge.Many pharmacological and nonpharmacologicaltreatments are available for management ofchronic pain and include a variety of noninvasiveas well as surgical and interventional procedures.The National Pain Strategy (NPS) report3 and2011 Institute of Medicine (IOM) report2 describethe need for evidence-based strategies for themanagement of chronic pain that address thebiopsychosocial nature of this problem, includingnonpharmacological treatment. Recently,guidelines on opioid use for chronic pain bythe CDC7 included a recommendation on thepreferred use of nonopioid treatment over opioidtherapy. These initiatives, and others, speak to theimportance of understanding current evidenceon noninvasive nonpharmacological treatment ofchronic pain.Musculoskeletal pain, particularly related to jointsand the back, is the most common type of chronicpain.2,8 This systematic review thus focuses on fiveof the most common causes of musculoskeletalpain: chronic low back pain, chronic neck pain,osteoarthritis, fibromyalgia and chronic tensionheadache.Rationale for This Review UpdateOur 2018 review1 provided some support forclinical strategies and policies that focus onnoninvasive nonpharmacological therapies forchronic pain that have evidence of sustainedeffectiveness after the completion of therapy, but2numerous evidence gaps were identified. Studiespublished subsequent to our previous review mayprovide additional evidence to address some ofthese gaps. This review provides the most currentevidence assessment and synthesis to informclinical practice and health policy. Our review isintended to address some of the needs described inthe NPS3 and IOM2 reports and others for evidenceto inform guidelines and healthcare policy(including reimbursement policy) related to useof noninvasive nonpharmacological treatments.It is one of three AHRQ reviews on chronic painmanagement; the other reviews focus on opioidand nonopioid medications respectively forchronic pain management. This review also aimsto provide additional insights into research gapsrelated to use of noninvasive nonpharmacologicalalternatives for treating five of the most commonchronic pain conditions.Scope and Key QuestionsThis Comparative Effectiveness Review focusedon noninvasive nonpharmacological therapy, witha Key Question (KQ) for each of five commonchronic pain conditions in adults:KQ 1: Chronic low back painKQ 2: Chronic neck painKQ 3: Osteoarthritis (knee, hip, hand)KQ 4: FibromyalgiaKQ 5: Chronic tension headacheKQ 6: Effects of age, sex, presence ofcomorbidities (e.g., emotional or mooddisorders), or degree of nociplasticity/centralsensitization on estimates of benefits andharmsFor each condition, we addressed the followingsubquestions:a. What are the benefits and harms of noninvasivenonpharmacological therapies comparedwith sham treatment, no treatment, waitlist,attention control, or usual care?
b. What are the benefits and harms of noninvasivenonpharmacological therapies comparedwith pharmacological therapy (e.g., opioids,nonsteroidal anti-inflammatory drugs(NSAIDS), acetaminophen, antiseizuremedications, antidepressants, topical agents,medical cannabis and muscle relaxants)?c. What are the benefits and harms of noninvasivenonpharmacological therapies compared withexercise or (for headache) biofeedback?Exercise was chosen as a common comparatorfor all conditions except headache, as it isrecommended in most guidelines for theseconditions and is a frequent comparator in thechronic pain literature. Interventions consideredin the review include exercise (includingaspects of physical therapy), mind-bodypractices (yoga, tai chi, qigong), psychologicalinterventions (cognitive behavioral therapy,biofeedback, relaxation techniques, acceptanceand commitment therapy), multidisciplinaryrehabilitation (including functional restoration),mindfulness practices (meditation, mindfulnessbased stress reduction practices), musculoskeletalmanipulation (e.g., chiropractic or osteopathicmanipulation), and physical modalities (traction,ultrasound, transcutaneous electrical nervestimulation [TENS], low-level laser therapy,interferential therapy, superficial heat or cold,bracing for knee, back or neck, electro-muscularstimulation and magnets), and acupuncture, witha focus on common single active interventionsand comparators. We assessed the persistence ofeffects for therapies at least 1 month followingcompletion of a course of treatment. Studies ofcombination or adjunctive interventions wereexcluded. We categorized interventions a priori toprovide a framework for the report, realizing thatthere is some overlap and that other methods forsuch categorization are possible. We performedstratified analyses to evaluate specific techniqueswithin broader intervention categories (e.g., welooked at different types of psychological therapiesor exercise).Details on the PICOTS (population, interventions,comparators, outcomes, timing, settings) inclusionand exclusion criteria are provided in the fullreport and in the published protocol.MethodsThe methods for this systematic review followthe AHRQ Methods Guide for Effectiveness andComparative Effectiveness Reviews.9 See the reviewprotocol invasive-nonpharm-pain-update/protocol) and the full report of the review foradditional details.Review ProtocolA multidisciplinary Technical Expert Panel wasconvened for this update review and providedinput into the draft protocol, as did the AHRQTask Order Officer and representatives from theCDC. The final version of the protocol for thisreview was posted on the AHRQ Effective HealthCare Program website invasive-nonpharm-painupdate/protocol) and registered in the PROSPEROinternational database of prospectively registeredsystematic reviews (CRD42019132457).Literature Search StrategyA research librarian conducted searches inOvid MEDLINE , Cochrane Central Registerof Controlled Trials, and Cochrane Databaseof Systematic Reviews. For the prior report, thesearches were conducted from inception throughNovmber 1, 2017 and for this update, fromSeptember 1, 2017 through September 20, 2019.ClinicalTrials.gov was searched for unpublishedtrials. A Federal Register notice was posted torequest submission of Supplemental Evidenceand Data for Systematic Reviews (SEADS) via anAHRQ portal. Responses received were reviewedand suggested citations and other data werecompared with the inclusion/exclusion criteria.No new trials eligible for inclusion were identifiedfrom these responses. Reference lists of included3
articles and the bibliographies of systematicreviews (published since 2010 for the prior report)were reviewed for includable literature.Inclusion and Exclusion Criteria, StudySelection, and Data AbstractionInclusion and exclusion criteria were developed apriori based on the Key Questions and PICOTS(populations, interventions, comparators,outcomes, timing, setting, study design) andare detailed in Table 1 of the full report and thepublished protocol. We focused on randomizedcontrolled trials (RCTs) reporting outcomes atleast 1 month following the completion of a courseof treatment. Trials comparing interventionswith placebo/sham and trials where no activeintervention was received (including usual care,waitlist control, minimal intervention) served asone set of comparators. To evaluate comparativeeffectiveness, exercise was chosen as a commonactive comparator for all conditions exceptheadache for which biofeedback was consideredthe common comparator, and we sought trialsof intervention compared with pharmacologicaltreatment.Details regarding process and inclusion/exclusionof studies are provided in the full report andAppendixes B and C. We abstracted data on studycharacteristics, funding source, populations,interventions, comparators, and results.Quality Assessment of Individual StudiesStudy quality was independently assessed by twoinvestigators using predefined criteria10,11 andbased on methods recommended in the AHRQMethods Guide for Effectiveness and ComparativeEffectiveness Research.9 Studies were rated as“good,” “fair,” or “poor.” (See Appendix E).Data Analysis and SynthesisMeta-analyses from the 2018 report wereupdated and new analyses conducted if two ormore studies could be combined. Data weresynthesized qualitatively (ranges and descriptive4analysis) and quantitatively using meta-analysiswhere appropriate.12 Duration of followuppostintervention was reported and categorized asshort term ( 6 months), intermediate term ( 6 to 12 months) and long term ( 12 months). Primaryoutcomes were function and pain.Analyses were stratified by disease type,intervention, control group (usual care, exerciseor pharmacological treatment) and length offollowup (short, intermediate, and long term). Weperformed additional sensitivity and subgroupanalyses based on specific interventions (e.g., typeof acupuncture, type of exercise, interventionintensity etc.) and control types, and by excludingoutlying studies and studies rated poor quality asdata permitted.We categorized the magnitude of effects forfunction and pain using the system describedin our previous reviews.13-15 We classified effectsfor measures with a 0 to 10 scale for pain orfunction as small (0.5 to 1 point), moderate( 1 to 2 points), or large ( 2 points). Themoderate range for functional outcomes roughlycorresponds to reported minimum clinicallyimportant differences for the measure. Smalleffects may not meet standard thresholds forminimal clinically important difference (MCID)but such thresholds may vary between patientsand small average effects may be associated withlarger effects in some patients. Where data wereavailable, proportions of patients meeting clinicallyimportant improvement were reported. In somesituations, interventions with small benefits may bewarranted (e.g., when harms and costs are small).Additional information is found in the full reportand Appendix H.Grading the Strength of Evidence forMajor Comparisons and OutcomesThe overall strength of evidence (SOE) for eachKQ and primary outcome (pain, function) wasgraded high, moderate, low, or insufficient basedon study limitations; consistency of results acrossstudies; the directness of the evidence linking
the interventions with health outcomes; effectestimate precision; and reporting bias.16,17 Whenall studies for a primary outcome were ratedpoor quality, we rated the SOE as insufficient (seeAppendix G). Summary strength of evidence tableswere updated based on the totality of underlyingevidence (i.e., the 2018 systematic review1 evidencein combination with that newly identified studies),and the impact of new trials on SOE is noted in thesummary tables.Peer Review and Public CommentaryPeer reviewers with expertise in primary careand management of the included chronic painconditions were invited to provide writtencomments on the draft report. The AHRQ TaskOrder Officer and an Evidence-based PracticeCenter Associate Editor also provided commentsand editorial review. The peer-reviewed draftreport was posted on the AHRQ website for 4weeks for public comment.ResultsResults of Literature SearchesThe original database searches resulted in 4,996potentially relevant articles; an additional 3520were identified for this update. After dual reviewof abstracts and titles, 1574 articles across searches(381 new to this update) were selected for fulltext dual review and 252 (34 new) publications(233 trials; 31 new trials) met inclusion criteria.We included 77 (9 new) trials (83 publications)on chronic low back pain, 27 (2 new) trials (28publications) on chronic neck pain, 62 (9 new)trials (66 publications) on osteoarthritis, 58 (11new) trials (66 publications) on fibromyalgia, andnine (0 new) trials (9 publications) on chronictension headache. The majority of trials comparednonpharmacological interventions with usualcare, waitlist, no treatment, attention control,or placebo/sham (93%); few trials employedpharmacological treatments (5%) or exercise(17%). (Note: some trials had more than onecomparator group.) Little evidence beyond 12months was available.The majority of trials (61%) were rated fairquality, with only 6 percent considered goodquality. Attrition was greater than 20 percent in 28percent of trials. For a number of interventions,providers and patients could not be effectivelyblinded. Other methodological shortcomings wereunclear reporting of randomization or allocationconcealment methods. Adherence to interventionswas poorly reported.Key points are presented in the following sectionsfor interventions and outcomes for which therewas low or moderate strength of evidence.All outcomes were considered to be direct.Interventions and outcomes with no or insufficientevidence are discussed in the full report. If effectestimates tended to favor one treatment but failedto reach statistical significance with confidenceinterval crossing the null value of zero or one(perhaps due to sample size), the results areinterpreted as showing no clear difference betweentreatments. If effect estimates are close to zero andnot statistically significant, results are interpretedas no difference between groups. Key findingsbased on the inclusion of new trials are indicatedin the bulleted points; otherwise findings are basedon evidence included in the prior report.Key Question 1: Chronic Low Back PainInterventions Compared With Usual Care,Waitlist, No Treatment, Attention Control, orSham Exercise: Exercise was associated with asmall improvement in short-term functioncompared with usual care, an attention control,or a placebo intervention (10 trials [4 new]);there were no effects on intermediate-term (5trials [2 new]) or long-term (1 trial) function(SOE: moderate for short term, low forintermediate and long term). For pain, exercisewas associated with moderate effects versususual care, an attention control, or a placebointervention at short-term (11 trials [5 new])and long-term (1 trial), and a small effect atintermediate-term (5 trials [2 new]) followup(SOE: low).5
Psychological Therapies: Psychological therapy(cognitive behavioral therapy [CBT] primarily)was associated with small improvements infunction and pain compared with usual careor an attention control at short-term (3 trials),intermediate-term (3 trials), and long-term (3trials) followup (SOE: moderate). Physical Modalities: Two trials foundinconsistent effects of ultrasound versus shamultrasound on short-term function (SOE:insufficient). Two trials found no differencesbetween ultrasound versus sham ultrasoundin short-term pain (SOE: low). One new trialfound interferential therapy associated witheffects on short-term function and pain thatwere below the threshold for small (statisticalsignificance uncertain) when comparedwith a placebo therapy (SOE: low). One trialfound low-level laser therapy associated witha small improvement compared with shamlaser for short-term function and a moderateimprovement for short-term pain (SOE: low).Two trials found no difference between tractionversus sham traction in short-term function orpain (SOE: low). Manual Therapies:– Spinal manipulation. Spinal manipulationwas associated with small improvementscompared with sham manipulation, usualcare, an attention control, or a placebointervention in short-term (3 trials) andintermediate-term (3 trials) function (SOE:low). There was no difference between spinalmanipulation versus sham manipulation,usual care, an attention control, or aplacebo intervention in short-term pain(3 trials), but manipulation was associatedwith a small improvement compared withcontrols on intermediate-term pain (3 trials)(SOE: low for short term, moderate forintermediate term).– Massage. Massage was associated with smallimprovements in short-term function (6trials [2 new]) and pain (5 trials [1 new])6compared with sham massage or usual care(SOE: moderate). There was no differencebetween massage versus controls inintermediate-term function or pain (3 trialseach) (SOE: low). Mindfulness-Based Stress Reduction (MBSR):There was no difference between MBSR versususual care or attention control in short-term(4 trials), intermediate-term (1 trial), or longterm (1 trial) function (SOE: low). MBSR wasassociated with a small improvement comparedwith usual care or an attention control inshort-term (3 trials) and intermediate-term (1trial) pain, but there was no difference betweengroups in long-term pain (1 trial) (SOE:moderate for short term, low for intermediateand long term). Mind-Body Practices: Yoga was associatedwith moderate improvement in function versusan attention or waitlist control at short-term(8 trials [2 new]), and small improvement atintermediate-term (3 trials) followup (SOE:moderate for short term, low for intermediateterm). For pain, yoga was associated with asmall improvement versus an attention orwaitlist control at short-term (7 trials [2 new]),and a moderate improvement at intermediateterm (2 trials) followup (SOE: low for shortterm, moderate for intermediate term). Acupuncture: Acupuncture was associated witha small improvement in short-term functioncompared with sham acupuncture or usualcare (
chronic pain. Musculoskeletal pain, particularly related to joints and the back, is the most common type of chronic . pain. 2,8. This systematic review thus focuses on five of the most common causes of musculoskeletal pain: chronic low back pain, chronic neck pain, osteoarthritis, fibromyalgia and chronic tension headache. Rationale for This .
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tant component of paramedic practice is re ected by the use of evidence-based guidelines for the relief of pain. However, these almost exclusively focus on acute pain and pharma-cological interventions. References to nonpharmacological therapies in Australian clinical guidelines for paramedics are uncommon, with the exception of traditional .
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