Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: A systematic review

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<ul><li><p>ity</p><p>nt</p><p>welus,ave</p><p>systematic search strategy was used to capture all LBP clinical trials of HVLA using our predened</p><p>gnized11%</p><p>The authors concluded that (1) care utilization for chronic LBP isvery high, including high use rates for advanced imaging, narcotics,and physical treatments; (2) use of evidence-based treatments arelow when compared with current best evidence; and (3) manytreatments are over-utilized. A recent review of clinical practice</p><p>Outcomes Research Institute (PCORI) in Washington, DC withinthe 2010 Patient Protection and Affordable Care Act by the US Con-gress has brought more focus and a growing acceptance of patient-perceived or patient-centered outcomes, at least in the context ofcomparative effectiveness research. While this has been a recentphenomenon, a patient-centered perspective has always been theprimary focus of SM research because of a lack of other availableoutcomes. A recent article found that the most commonly used pa-tient-based outcome assessments in chiropractic SM research were</p><p> Corresponding author. Address: 741 Brady St., Davenport, IA 52803, UnitedStates. Tel.: +1 563 884 5150.</p><p>Journal of Electromyography and Kinesiology 22 (2012) 670691</p><p>Contents lists available at</p><p>gr</p><p>elsE-mail address: christine.goertz@palmer.edu (C.M. Goertz).per quality-adjusted life year of $13,015 (Dagenais et al., 2008;Walker, 2000). Point prevalence within the last 3 months is esti-mated at 17% (Deyo et al., 2006). At the most recent meeting ofthe Tenth International Forum for Primary Care Research on LowBack Pain participants concluded that the LBP epidemic remainsa burden in Western countries (Pransky et al., 2011).</p><p>There is no single standard approach to medical care for LBP.Carey et al. recently conducted a survey examining health care uti-lization patterns in patients with chronic LBP (Carey et al., 2009).They found high health care utilization in this group, with an aver-age of 21 visits to 2.7 provider-types annually. Many of the testsand treatments used did not conform to evidence-based practice.</p><p>Spinal manipulation (SM) is commonly used to treat low backpain (LBP). SM is the therapeutic application of a load (force) tospecic body tissues (usually vertebral joints). Load delivery varieswith respect to velocity, amplitude, frequency, choice of lever, anddirection of force application (Herzog, 2000; Triano, 2000).</p><p>Because little is understood about the pathophysiology of mostLBP, and the exact mechanism(s) of action of SMs effect on LBP islargely unknown, clinical trials have primarily depended upon pa-tient-perceived outcomes such as pain level and functional healthstatus (Bronfort et al., 2008; Lawrence et al., 2008). These have tra-ditionally been considered soft outcomes by the scientic com-munity. However, the recent creation of the Patient-CenteredLow back pain (LBP) is a well-recowith lifetime prevalence ranging from1. Introduction1050-6411/$ - see front matter 2012 Published byhttp://dx.doi.org/10.1016/j.jelekin.2012.03.006patient-centered outcomes: visual analogue scale, numerical pain rating scale, Roland-Morris DisabilityQuestionnaire, and the Oswestry Low Back Pain Disability Index. Of the 1294 articles identied by oursearch, 38 met our eligibility criteria. Like previous SM for LBP systematic reviews, this review showsa small but consistent treatment effect at least as large as that seen in other conservative methods of care.The heterogeneity and inconsistency in reporting within the studies reviewed makes it difcult to drawdenitive conclusions. Future SM studies for LBP would benet if some of these issues were addressed bythe scientic community before further research in this area is conducted.</p><p> 2012 Published by Elsevier Ltd.</p><p>public health problemto 84% and median cost</p><p>guidelines for the treatment of LBP found that acute LBP manage-ment recommendations included three interventions: patient edu-cation, acetaminophen or nonsteroidal anti-inammatory andspinal manipulation (Dagenais et al., 2010).Patient-centered outcomes primary objective of this paper was to describe the current literature on patient-centered outcomes fol-lowing a specic type of commonly used SM, high-velocity low-amplitude (HVLA), in patients with LBP. AReview</p><p>Patient-centered outcomes of high-velocfor low back pain: A systematic review</p><p>C.M. Goertz a,, K.A. Pohlman a, R.D. Vining a, J.W. Braa Palmer College of Chiropractic, Davenport, IA, 741 Brady St. United Statesb Private Practice, 3180 Willow Ln 20 Thousand Oaks, CA, United States</p><p>a r t i c l e i n f o</p><p>Keywords:Spinal manipulationLow back pain</p><p>a b s t r a c t</p><p>Low back pain (LBP) is aapproach to treatment. Th(SM). Many clinical trials h</p><p>Journal of Electromyo</p><p>journal homepage: www.Elsevier Ltd., low-amplitude spinal manipulation</p><p>inghamb, C.R. Long a</p><p>l-recognized public health problem with no clear gold standard medicalthose with LBP frequently turn to treatments such as spinal manipulationbeen conducted to evaluate the efcacy or effectiveness of SM for LBP. The</p><p>SciVerse ScienceDirect</p><p>aphy and Kinesiology</p><p>evier .com/locate / je lek in</p></li><li><p>2006; Walker et al., 2010). The majority have found that SM con-</p><p>and the two most commonly used patient-reported measures of</p><p>2.4. Selection criteria</p><p>the author; 3 involved adult human subjects, 18 years of ageor older; 4 included HVLA as a category of spinal manipulativetherapy; however, studies of SM under anesthesia were ex-cluded; 5 a randomized clinical trial that included a separateand distinct control or comparative treatment group; 6 articlesthat used intention-to-treat analysis and had extractable data; 7 use of one or more of the following patient-centered out-comes: VAS, NRS, RM, and OSW. SF-36 data were not includedin this review because the majority of studies reviewed providedSF-36 data only when describing baseline characteristics. Studiesincluding other forms of SM (e.g. mobilization techniques) thatdid not have an HVLA arm were not included. Mechanistic andbasic science trials conducted on human participants were ex-cluded as were studies where the only comparative group wasanother SM method.</p><p>2.5. Operational denitions</p><p>For purposes of this review, SM was dened as a manuallydelivered high-velocity low-amplitude force or thrust applied toa vertebral or pelvic joint with the intent of creating a momentaryseparation of joint surfaces and cavitation. Components of SM,such as velocity and amplitude, have variable ranges of implemen-tation. Most denitions of SM refer to a thrust or an increasingmagnitude of force that peaks over a nite period of time (Evans,2010; Evans and Lucas, 2010). Cavitation alone is not considereda necessary component, though it is often considered one of the</p><p>grap2. Methods</p><p>2.1. Sources of information</p><p>The relevant studies were identied using the following dat-abases: PubMED (an index to Medline), the Cochrane Library, andIndex to Chiropractic Literature (ICL). All databases were searchedfrom inception through April 2011.</p><p>2.2. Search terms and delimiters</p><p>Search terms for all databases (except ICL) were low back painOR back OR back pain OR back injuries OR sciatica ORLBP AND manip OR mobili OR manual therap. The ICLdatabase was searched using low back pain OR back OR backpain OR back injuries OR sciatica OR LBP. All searches werelimited to those studies written in English and involving humansubjects.</p><p>2.3. Search strategy</p><p>As shown in Fig. 1, a systematic search strategy was used tocapture all LBP clinical trials of SM using our predened patient-centered outcomes. First, the sources of information were searchedusing the search terms and delimiters. We then cross referencedour ndings with MESH headings and hand-checked reference listsof relevant studies to identify cited articles not captured by elec-tronic searches. Two independent reviewers screened all of the po-tential relevant studies for selection criteria. Discrepancies werelow back function (RM and OSW) in order to discern both similar-ities and differences in use and meaning. Included studies were re-stricted to those whose primary or secondary outcome was VAS,NRS, RM, and/or OSW. This allowed us to concentrate on studiesthat had similar outcome measures, decreasing heterogeneitywhile still including the most recent studies available. The primaryobjective of this paper was to describe the current literature on pa-tient-centered outcomes in randomized controlled trials of HVLASM in patients with low back pain.veys a modest but consistent benet for patients with LBP at leastas large as commonly used alternative treatments. This is despitemarked heterogeneity in study design and quality.</p><p>Our review is unique in that only studies comparing high-veloc-ity, low-amplitude (HVLA) SM are included because HVLA SM iscommonly used both in clinical trials and in the clinical setting(Christensen et al., 2010). We also present these data in a way thatallows us to separately consider the data from specic patient-cen-tered outcome instruments. In this paper we present tables show-ing the two most commonly used pain rating scales (NRS and VAS)a mix of both pain and functional health status measures, includingthe Visual Analogue Scale (VAS), the Numerical Rating Scale (NRS),the RolandMorris Disability Questionnaire (RM), the Oswestry LowBack Pain Disability Index (OSW) and the Short Form-36 (SF-36)(Khorsan et al., 2008).</p><p>Numerous systematic reviews evaluating the effects of variousSM techniques for low back pain have been conducted over thepast 10 years (Assendelft et al., 2003; Bronfort et al., 2010; Ferreiraet al., 2003; Furlan et al., 2010; Koes et al., 2010; Pengel et al.,2002; Rubinstein et al., 2011; van Tulder et al., 2005; van Tulder,</p><p>C.M. Goertz et al. / Journal of Electromyosettled by a third independent reviewer (KAP). Second, abstractswere screened for absolute exclusionary criteria by an independentreviewer with any discrepancies resolved by at least three otherArticles were included if they met the following criteria: 1 English language; 2 non-specic low back pain as identied byreviewers. The nal step was a full-text review for selection criteriaconducted as a group by at least four of the authors.</p><p>169of full-text articles assessed </p><p>for eligibility</p><p>131of full-text articles </p><p>excluded:(Table 2)28 Data</p><p>28 Outcomes26 Secondary Paper</p><p>26 No SM16 Not a RCT</p><p>7 No LBP</p><p>38of studies included</p><p>(Table 3)</p><p>Fig. 1. Literature retrieval process ow chart.1294 of records identifed through </p><p>database searching and hand-checked reference lists of </p><p>relevant studies(Including duplicate records)</p><p>1040of records excluded</p><p>254of abstracts screened for </p><p>selection criteria</p><p>85of records excluded:</p><p>(Table 1)14 No LBP14 No SM</p><p>57 Not a RCT</p><p>hy and Kinesiology 22 (2012) 670691 671goals of this procedure. Manual contacts over the intended verte-bral or pelvic joint (short lever) or over distant sites (long lever)were considered under our denition of spinal manipulation.</p></li><li><p>For this review, patient-centered outcomes have been given theoperational denition: patient self-report questionnaires related topain and physical/emotional/social functioning.</p><p>Currently few methods exist to reliably conrm a specic diag-nosis for the cluster of symptoms categorized as non-specic oridiopathic LBP. However, identifying specic patient characteristicsof LBP can demarcate similarities and differences between studypopulations. We found that symptom duration varied widelyamong the included study population and therefore added a classi-cation to each study based upon guideline denitions by the 2007American College of Physicians and American Pain Society: acute</p><p>Between-groups, we extracted mean differences and CIs di-</p><p>The modied Roland-Morris Disability Questionnaire assesses</p><p>exceptions, long-term outcomes were similar to short-term</p><p>672 C.M. Goertz et al. / Journal of Electromyograprectly from the article when possible. Some articles reported differ-ences in mean changes and some reported differences in follow-upmeans adjusted for the baseline outcome variable. Some articlesadjusted for covariates and others did not. We have not distin-guished between these different methods. When between-groupdifferences were not reported, we calculated them by using the re-ported group means. If group means were not given, we used thewithin-group means calculated as described above. When be-</p><p>Quebec Task Force classification1. LBP without radiation2. LBP + radiation to extremity, proximally3. LBP + radiation to extremity, distally4. LBP + radiation to limb with presence of neurologic signs5. Presumptive compression of a spinal nerve root 6. Compression of a nerve root confirmed by specific imaging techniques7. Spinal Stenosis8. Post surgical status &lt; 6 months9. Post surgical status &gt; 6 months10. Chronic pain syndromepain (04 wks), subacute pain (412 wks), and chronic pain (12or more wks) (Chou et al., 2007). Study populations were furtherclassied according to the Quebec Task Force (QTF) classicationsystem (Fig. 2) (Spitzer et al., 1995).</p><p>The timing of the primary endpoint for each study is presentedin the tables. For those studies reporting outcomes at durations be-yond the primary endpoint, we included the longest term follow-up available, up to 1 year.</p><p>2.6. Data extraction</p><p>For each article we extracted means, standard deviations (SD)and condence intervals (CI) from the tables and text, but not fromgures. We converted VAS scores reported in cm to mm and OSWscores reported on a 50-point scale to a 100-point scale. For articleswhere median and interquartile ranges were reported, we assumedthe median was equivalent to the mean and the interquartile rangewas equivalent to 1.35 times the standard deviation (Higgins andGreen, 2009).</p><p>Within each group, we extracted mean changes betweenbaseline and follow-up with condence intervals directly fromthe article when possible. When only the means for baseline andfollow-up were given, we calculated the difference between meansrecognizing that the actual mean change could differ due to miss-ing data. When the SD of a change was given, we used it to esti-mate the standard error (SE) and calculate a 95% CI. When the SDof the change variable was not reported, but the SD of both thebaseline and follow-up variables were, we conservatively assumedthere was no correlation between baseline and follow-up measuresto estimate the SD of the change variable. We then used this SD toestimate the SE and calculate a 95% CI.11. Other diagnoses</p><p>Fig. 2. Quebec task force (QTF) classication system.outcomes.The Oswestry Low Back Pain Disability Index consists of 10</p><p>questions assessing pain intensity and limitations in various activ-ities (Fairbank et al., 1980). Scores range from 0 to 50 points andare transformed into a percentage score, or score out of 100 points.The MCID is 6%, with recent discussion suggesting that the MCIDLBP-related disability and has a MCID estimated at 23.5 points(Bombardier et al., 2001; Ostelo and de Vet, 2005). The RM is a1-page questionnaire and has shown both goo...</p></li></ul>

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