J Electromyogr Kinesiol. 2012 (Oct); 22 (5): 670-691 ~ FULL TEXT
Goertz CM, Pohlman KA, Vining RD, Brantingham JW, Long CR.
Palmer College of Chiropractic,
741 Brady St.,
Davenport, IA, United States.
Low back pain (LBP) is a well-recognized public health problem with no clear gold standard medical approach to treatment. Thus, those with LBP frequently turn to treatments such as spinal manipulation (SM). Many clinical trials have been conducted to evaluate the efficacy or effectiveness of SM for LBP.
The primary objective of this paper was to describe the current literature on patient-centered outcomes following a specific type of commonly used SM, high-velocity low-amplitude (HVLA), in patients with LBP. A systematic search strategy was used to capture all LBP clinical trials of HVLA using our predefined patient-centered outcomes: visual analogue scale, numerical pain rating scale, Roland-Morris Disability Questionnaire, and the Oswestry Low Back Pain Disability Index.
Of the 1,294 articles identified by our search, 38 met our eligibility criteria. Like previous SM for LBP systematic reviews, this review shows a 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 difficult to draw definitive conclusions. Future SM studies for LBP would benefit if some of these issues were addressed by the scientific community before further research in this area is conducted.
Palmer Research Summary Series
In this study, authors systematically searched the scientific literature (1974-2011) reporting randomized clinical trials including high velocity, low amplitude (HVLA) spinal manipulation (SM) for low back pain (LBP).
Patient-centered outcomes measured were the:
Visual Analogue Scale (VAS)
Numerical Rating Scale (NRS)
Roland-Morris Disability Questionnaire (RM), and the
Oswestry Low Back Pain Disability Index (OSW).
Study results included:
Of 1294 articles identified in the initial publication search, 38 met the criteria for the study
The 2 most common pain rating scales were - NRS and VAS
The 2 most common patient-reported measures of low back function were - RM and OSW
Small but consistent pain reduction and functional improvement followed HVLA-SM treatment
Heterogeneity in study methods and inconsistency in reporting/recording pain limited more
HVLA SM provides a small and consistent pain reducing and functional improvement effect, greater than or equal to other conservative treatments available for patients with LBP.
Doctors and patients can be confident in recommending or choosing to receive HVLA-SM for LBP. The body of research supporting its effectiveness relative to other available treatments
suggests patients have the choice of several treatment options. Future research would benefit from consistent study designs and pain measurement/reporting. Reporting clear details of the frequency and timing of treatments used in clinical trials would also be useful.
Thanks to Palmer College for access to this research summary
From the FULL TEXT Article:
Low back pain (LBP) is a well-recognized public health problem with lifetime prevalence ranging from 11% to 84% and median cost per quality-adjusted life year of $13,015 (Dagenais et al., 2008; Walker, 2000). Point prevalence within the last 3 months is estimated at 17% (Deyo et al., 2006). At the most recent meeting of the Tenth International Forum for Primary Care Research on Low Back Pain participants concluded that ‘‘the LBP epidemic remains a burden in Western countries’’ (Pransky et al., 2011).
There is no single standard approach to medical care for LBP.
Carey et al. recently conducted a survey examining health care utilization patterns in patients with chronic LBP (Carey et al., 2009). They found high health care utilization in this group, with an average of 21 visits to 2.7 provider-types annually. Many of the tests and treatments used did not conform to evidence-based practice.
The authors concluded that
(1) care utilization for chronic LBP is very high, including high use rates for advanced imaging, narcotics, and physical treatments;
(2) use of evidence-based treatments are low when compared with current best evidence; and
(3) many treatments are over-utilized. A recent review of clinical practice guidelines for the treatment of LBP found that acute LBP management recommendations included three interventions: patient education, acetaminophen or nonsteroidal anti-inflammatory and spinal manipulation (Dagenais et al., 2010).
Spinal manipulation (SM) is commonly used to treat low back pain (LBP). SM is the therapeutic application of a load (force) to specific body tissues (usually vertebral joints). Load delivery varies with respect to velocity, amplitude, frequency, choice of lever, and direction of force application (Herzog, 2000; Triano, 2000).
Because little is understood about the pathophysiology of most
LBP, and the exact mechanism(s) of action of SM’s effect on LBP is largely unknown, clinical trials have primarily depended upon patient-perceived outcomes such as pain level and functional health status (Bronfort et al., 2008; Lawrence et al., 2008). These have traditionally been considered ‘‘soft’’ outcomes by the scientific community. However, the recent creation of the Patient-Centered Outcomes Research Institute (PCORI) in Washington, DC within the 2010 Patient Protection and Affordable Care Act by the US Congress has brought more focus and a growing acceptance of patientperceived or ‘‘patient-centered’’ outcomes, at least in the context of comparative effectiveness research. While this has been a recent phenomenon, a patient-centered perspective has always been the primary focus of SM research because of a lack of other available outcomes.
A recent article found that the most commonly used patient-based outcome assessments in chiropractic SM research were a mix of both pain and functional health status measures, including
the Visual Analogue Scale (VAS),
the Numerical Rating Scale (NRS),
the Roland Morris Disability Questionnaire (RM),
the Oswestry Low Back Pain Disability Index (OSW) and
the Short Form-36 (SF-36) (Khorsan et al., 2008).
Numerous systematic reviews evaluating the effects of various
SM techniques for low back pain have been conducted over the
past 10 years (Assendelft et al., 2003; Bronfort et al., 2010; Ferreira et 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, 2006; Walker et al., 2010). The majority have found that SM conveys a modest but consistent benefit for patients with LBP at least as large as commonly used alternative treatments. This is despite marked heterogeneity in study design and quality.
Our review is unique in that only studies comparing high-velocity, low-amplitude (HVLA) SM are included - because HVLA SM is commonly used both in clinical trials and in the clinical setting (Christensen et al., 2010). We also present these data in a way that allows us to separately consider the data from specific patient-centered outcome instruments. In this paper we present tables showing the two most commonly used pain rating scales (NRS and VAS) and the two most commonly used patient-reported measures of low back function (RM and OSW) in order to discern both similarities and differences in use and meaning. Included studies were restricted to those whose primary or secondary outcome was VAS, NRS, RM, and/or OSW. This allowed us to concentrate on studies that had similar outcome measures, decreasing heterogeneity while still including the most recent studies available. The primary objective of this paper was to describe the current literature on patient-centered outcomes in randomized controlled trials of HVLA SM in patients with low back pain.
Sources of information
The relevant studies were identified using the following databases: PubMED (an index to Medline), the Cochrane Library, and Index to Chiropractic Literature (ICL). All databases were searched from inception through April 2011.
Search terms and delimiters
Search terms for all databases (except ICL) were
‘‘low back pain’’ OR ‘‘back’’ OR ‘‘back pain’’ OR ‘‘back injuries’’ OR ‘‘sciatica’’ OR ‘‘LBP’’ AND ‘‘manip’’ OR ‘‘mobili’’ OR ‘‘manual therap.’’
The ICL database was searched using
‘‘low back pain’’ OR ‘‘back’’ OR ‘‘back pain’’ OR ‘‘back injuries’’ OR ‘‘sciatica’’ OR ‘‘LBP.’’
All searches were limited to those studies written in English and involving human
As shown in Figure 1, a systematic search strategy was used to capture all LBP clinical trials of SM using our predefined patientcentered outcomes. First, the sources of information were searched using the search terms and delimiters. We then cross referenced our findings with MESH headings and hand-checked reference lists of relevant studies to identify cited articles not captured by electronic searches. Two independent reviewers screened all of the potential relevant studies for selection criteria. Discrepancies were settled by a third independent reviewer (KAP). Second, abstracts were screened for absolute exclusionary criteria by an independent reviewer with any discrepancies resolved by at least three other reviewers. The final step was a full-text review for selection criteria conducted as a group by at least four of the authors.
Articles were included if they met the following criteria:
1 - English language;
2 - non-specific low back pain as identified by the author;
3 - involved adult human subjects, 18 years of age or older;
4 - included HVLA as a category of spinal manipulative therapy;
however, studies of SM under anesthesia were excluded;
5 - a randomized clinical trial that included a separate and distinct control or comparative treatment group;
6 - articles that used intention-to-treat analysis and had extractable data;
7 - use of one or more of the following patient-centered outcomes: VAS, NRS, RM, and OSW.
SF-36 data were not included in this review because the majority of studies reviewed provided SF-36 data only when describing baseline characteristics. Studies including other forms of SM (e.g. mobilization techniques) that did not have an HVLA arm were not included. Mechanistic and basic science trials conducted on human participants were excluded as were studies where the only comparative group was another SM method.
For purposes of this review, SM was defined as a manually
delivered high-velocity low-amplitude force or thrust applied to
a vertebral or pelvic joint with the intent of creating a momentary separation of joint surfaces and cavitation. Components of SM, such as velocity and amplitude, have variable ranges of implementation. Most definitions of SM refer to a thrust or an increasing magnitude of force that peaks over a finite period of time (Evans, 2010; Evans and Lucas, 2010). Cavitation alone is not considered a necessary component, though it is often considered one of the goals of this procedure. Manual contacts over the intended vertebral or pelvic joint (short lever) or over distant sites (long lever) were considered under our definition of spinal manipulation.
For this review, patient-centered outcomes have been given the
operational definition: patient self-report questionnaires related to pain and physical/emotional/social functioning.
Currently few methods exist to reliably confirm a specific diagnosis for the cluster of symptoms categorized as non-specific or idiopathic LBP. However, identifying specific patient characteristics of LBP can demarcate similarities and differences between study populations. We found that symptom duration varied widely among the included study population and therefore added a classification to each study based upon guideline definitions by the 2007 American College of Physicians and American Pain Society: acute pain (0-4 wks), subacute pain (4-12 wks), and chronic pain (12 or more wks) (Chou et al., 2007). Study populations were further classified according to the Quebec Task Force (QTF) classification system (Figure 2) (Spitzer et al., 1995).
The timing of the primary endpoint for each study is presented
in the tables. For those studies reporting outcomes at durations beyond the primary endpoint, we included the longest term followup available, up to 1 year.
For each article we extracted means, standard deviations (SD)
and confidence intervals (CI) from the tables and text, but not from figures. We converted VAS scores reported in cm to mm and OSW scores reported on a 50-point scale to a 100-point scale. For articles where median and interquartile ranges were reported, we assumed the median was equivalent to the mean and the interquartile range was equivalent to 1.35 times the standard deviation (Higgins and Green, 2009).
Within each group, we extracted mean changes between
baseline and follow-up with confidence intervals directly from
the article when possible. When only the means for baseline and
follow-up were given, we calculated the difference between means
recognizing that the actual mean change could differ due to missing data. When the SD of a change was given, we used it to estimate the standard error (SE) and calculate a 95% CI. When the SD of the change variable was not reported, but the SD of both the baseline and follow-up variables were, we conservatively assumed there was no correlation between baseline and follow-up measures to estimate the SD of the change variable. We then used this SD to estimate the SE and calculate a 95% CI.
Between-groups, we extracted mean differences and CIs directly
from the article when possible. Some articles reported differences in mean changes and some reported differences in follow-up means adjusted for the baseline outcome variable. Some articles adjusted for covariates and others did not. We have not distinguished between these different methods. When between-group differences were not reported, we calculated them by using the reported group means. If group means were not given, we used the within-group means calculated as described above. When between-group CIs were not reported, we calculated a pooled estimate of the SDs using the reported within-group SDs or those
estimated as described above when within-group SDs were not reported. The pooled estimate of the SDs was then used to estimate the standard error of the differences between means to calculate a 95% CI.
Risk of bias
Independent quality rating went beyond the scope of this study.
However, we reviewed and combined quality ratings from 2 Cochrane and 1 Agency for Healthcare Research and Quality reviews (Furlan et al., 2010; Rubinstein et al., 2011; Walker et al., 2010) for the studies included in this review.
Of the 1,294 articles identified by our initial search, 38 articles met the selection criteria (Fig. 1).
The first three tables show studies that were:
(1) excluded based on abstract (Table 1); (Page 673)
(2) excluded based on full article assessment (Table 2) (Page 674); and
. (Page 676)
(Tables 47) give with-in group mean changes and between-group mean differences with 95% CIs of the VAS, NRS, RM and OSW, respectively, for the studies included in this review. Below is a description of each patient-centered outcome measure with a brief summary of our findings.
The visual analogue scale is a 100-mm line. The ends of the
line are anchored with response categories, which are generally
‘‘no pain’’ at the 0 mm end of the line and a descriptor such
as ‘‘unbearable pain’’ or ‘‘worst pain possible’’ at the 100 mm
end of the line. The minimum clinically important difference
(MCID) is defined as the smallest difference in the outcome perceived by patients as beneficial (Jaeschke et al., 1989). The MCID for VAS has been reported to range from 20 to 35 mm, with the smaller difference typically for subacute and chronic LBP patients and the larger difference for acute LBP patients (Hagg
et al., 2003; Ostelo and de Vet, 2005; Vela et al., 2011). Mean
change scores were similar at both short and long term followups
The numerical pain rating scale asks participants to rate their
level of pain on an ordinal 11 point scale, anchored with response categories in which 0 represents ‘‘no pain’’ and 10 represents ‘‘unbearable pain’’ or ‘‘worst pain possible’’ (Table 5). The MCID is considered to be a change of 2.5 points (van der Roer et al., 2006). Between-group treatment effects tended to favor SM, but the differences were not clinically or statistically significant.
The modified Roland-Morris Disability Questionnaire assesses
LBP-related disability and has a MCID estimated at 2-3.5 points
(Bombardier et al., 2001; Ostelo and de Vet, 2005). The RM is a
1-page questionnaire and has shown both good reliability and
validity (Roland and Fairbank, 2000) and is sensitive to clinical change in patients with LBP (Deyo et al., 1990; Riddle et al., 1998; Stratford et al., 2000). Within-group changes were higher in studies focused on acute LBP when compared to chronic LBP (Table 5). Between-group differences were inconsistent. With rare exceptions, long-term outcomes were similar to short-term outcomes.
The Oswestry Low Back Pain Disability Index consists of 10
questions assessing pain intensity and limitations in various activities (Fairbank et al., 1980). Scores range from 0 to 50 points and are transformed into a percentage score, or score out of 100 points. The MCID is 6%, with recent discussion suggesting that the MCID should be 10% (Ostelo et al., 2008; Vela et al., 2011). Long-term outcomes, when available, were similar to short-term outcomes (Table 6).
We were interested in summarizing effect sizes in SM and SM+
(other therapies such as physical therapy, medical care, exercise). To accomplish this goal we averaged across mean change scores within-groups and differences of mean change scores betweengroups (Table 8). A wide range of mean change scores were found both within and between-groups across all measures. Withingroup SM + scores were slightly higher. However, this was not true between-groups. The vast majority of comparison groups were active. There are too few sham control groups to draw any conclusions regarding effect sizes of active versus sham study designs.
In Table 9 we present quality ratings for the 20 articles included in this review that were evaluated for quality in one or more of 3 other reviews (Furlan et al., 2010; Rubinstein et al., 2011; Walker et al., 2010). Overall, ratings for the majority of papers showed important gaps in quality markers for RCT study design, especially related to risk of bias, influence of co-intervention, and compliance with interventions.
Although this review specifically focused on studies with HVLA
SM as the primary treatment of interest, our findings are consistent with those found in the latest reviews of SM for LBP that incorporate the most recently published trials (Assendelft et al., 2003; Bronfort et al., 2010; Ferreira et 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, 2006; Walker et al., 2010). We agree with previous conclusions that, although the data are generally insufficient to make strong recommendations, SM appears to be one of several effective treatment options for both acute and chronic
LBP (Assendelft et al., 2003; Bronfort et al., 2004a; Koes et al., 1996; van Tulder et al., 1997; van Tulder, 2006).
We also share concerns over the highly variable quality of extant trials, small effect sizes and large variation in outcomes (Assendelft et al., 2003; Bronfort et al., 2004b; Rubinstein et al., 2011) and agree that the variation is most likely due to a combination of deficient trial methodology, inadequate execution and reporting, the large and non-quantified variation in the SM, and the unknown heterogeneity of LBP patients (Furlan et al., 2010; Hurwitz, 2011; Rubinstein et al., 2011).
The majority of studies included both pain and function as primary and/or secondary outcomes. For pain, either the VAS or NRS was used, while function was measured using either the RM or the OSW. VAS was more widely used than NRS (20 used VAS vs. 8 used NRS), while use of RM and OSW were about equally divided (20 RM vs. 16 OSW). Two studies used both RM and OSW. In the majority of studies, authors did not present a rationale for why one particular pain or function measure was chosen over others. RM was more often used when the provider type was either a DO or a DC, while those studies with a PT provider used either RM or OSW.
While formal assessment of article quality was not specifically
included as part of this review effort, we did observe several issues related to quality that potentially impact our ability to derive useful conclusions from this and similar systematic reviews. For instance, we believe that the wide ranges found in pain change scores between studies are more likely to represent differences in how the data were collected rather than real differences in treatment effect. Specifics regarding VAS anchors were provided in only slightly more than half the studies and, when presented, descriptors varied widely, from ‘‘no pain’’ to ‘‘worst pain,’’ ‘‘pain as bad as it could be,’’ ‘‘max pain,’’ ‘‘worst pain you have ever felt,’’ ‘‘unbearable pain’’ or ‘‘worst imaginable pain/symptoms.’’ The time frame within which participants were asked to rate their pain also varied widely, ranging from ‘‘current’’ to ‘‘within the past 14 days.’’
It is equally difficult to evaluate NRS scores due to lack of consistency in both anchor descriptors and time frame in which the participant was asked to assess his or her pain. Time frames ranged from ‘‘current pain’’ to ‘‘pain over the past 2 weeks,’’ while anchors ranged from ‘‘no pain’’ to either ‘‘worst pain possible’’ or ‘‘worst pain imaginable.’’ In 5 out of 8 studies that used the NRS as a primary or secondary outcome, the anchor descriptors were not specified.
Substantial variability in how pain was recorded and reported,
in combination with the lack of a gold standard function measure, made it difficult to adequately summarize outcomes of clinical trials of HVLA SM for LBP. For this reason we chose not to conduct a meta-analysis or formally synthesize the results. ‘‘Industry standards’’ for measuring both pain and physical functioning in patients with low back pain would make comparisons between SM studies more relevant. It has recently been suggested that assessing the functional capacity of patients may be of greater clinical value than assessing reported pain levels (Pransky et al., 2011). Also, the National Institutes of Health-funded PROMIS initiative has fostered the creation of new measures of both pain and physical functioning that may be useful in the study of LBP (Gershon et al., 2010). These are issues that warrant further discussion among SM investigators.
In our review of these papers, we became aware of other opportunities for standardization. Adherence to the recently updated CONSORT standards (Moher et al., 2010) by SM investigators would help with this effort.
Specifically, we recommend
(1) providing clear descriptions of intervention groups, including SM, in sufficient detail to allow for replication and
(2) describing eligibility criteria in detail.
Adoption of standard classifications to better describe
the nature of LBP studied in a particular trial would also be
useful. While diagnostic code classifications such as ICD-9 or ICD-10 are theoretically more specific, current differences in diagnostic approaches between provider types limit their usefulness in research studies. However, describing LBP according to the Quebec Task Force classifications would be an improvement over current reporting efforts. Also, while the majority of studies we reviewed reported on whether participants had acute, sub-acute or chronic LBP, definitions for these terms were not consistent.
Future studies of SM for LBP would also benefit from the adoption of reporting standards regarding SM intervention delivery. In this review, it was difficult to find consistent information regarding the frequency and/or timing of SM and other treatment visits, or the number of procedures delivered at each visit. Given the complexity of and skill level required for the delivery of SM techniques such as HVLA (Triano et al., 2004), articles would also benefit from inclusion of both the credentials of the clinicians delivering SM or related procedures and their level of expertise (e.g. years in clinical practice, experience with the SM procedure under evaluation).
We found that HVLA SM for LBP appears to convey a small but
consistent treatment effect at least as large as that seen in other conservative methods of care. This finding is similar to that in other systematic reviews of SM of LBP. The heterogeneity and inconsistency in reporting within the studies reviewed makes it difficult to draw definitive conclusions or adequately summarize patient-centered outcomes for clinical trials of HVLA SM for LBP. These are issues that should be addressed by the scientific community before future SM studies for LBP are conducted.
We gratefully acknowledge the contributions of: clinical research fellows James Boysen, Christopher Woslanger, Julie Kumar, Christopher Roecker, Amin Neekomand, and Connie Mitchell; summer intern Laura Macko; Ying Cao; Leah Cafer; and Paige Morgenthal for help in literature searching, data extraction and
manuscript preparation. We also thank Dana Lawrence and Joel
Pickar for their critical review of the manuscript.
Thirty-eight articles that met eligibility criteria
United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial:
Effectiveness of Physical Treatments for Back Pain in Primary Care
British Medical Journal 2004 (Dec 11); 329 (7479): 13771384
Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA,
A comparison of osteopathic spinal manipulation with standard care for patients with low back pain.
Aure, OF, Nilsen, JH, and Vasseljen, O.
Manual Therapy and Exercise Therapy in Patients With Chronic Low Back Pain:
A Randomized, Controlled Trial With 1-Year Follow-Up
Spine (Phila Pa 1976) 2003 (Mar 15); 28 (6): 525531
Bicalho E, Setti JA, Macagnan J, Cano JL, Manffra EF.
Immediate effects of a high-velocity spine manipulation in paraspinal muscles activity of
nonspecific chronic low-back pain subjects.
Man Ther 2010;15(5):46975.
Bishop PB, Quon JA, Fisher CG, Dvorak MF.
The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) Study:
A Randomized Controlled Trial on the Effectiveness of Clinical Practice Guidelines
in the Medical and Chiropractic Management of Patients with Acute Mechanical Low Back Pain
Spine J. 2010 (Dec); 10 (12): 1055-1064
Bronfort G, Goldsmith CH, Nelson CF, Boline PD, Anderson AV.
Trunk Exercise Combined with Spinal Manipulative or NSAID Therapy
for Chronic Low Back Pain: A Randomized, Observer-blinded Clinical Trial
J Manipulative Physiol Ther. 1996 (Nov); 19 (9): 570582
Bronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH, Jr.:
Supervised Exercise, Spinal Manipulation, and Home Exercise for Chronic Low Back Pain:
A Randomized Clinical Trial
Spine J. 2011 (Jul); 11 (7): 585598
Burton AK, Tillotson KM, Cleary J.
Single-blind Randomised Controlled Trial of Chemonucleolysis and Manipulation
in the Treatment of Symptomatic Lumbar Disc Herniation
European Spine Journal 2000 (Jun); 9 (3): 202207
Cecchi, F., Molino-Lova, R., Chiti, M. et al.
Spinal Manipulation Compared with Back School and with Individually Delivered Physiotherapy for
the Treatment of Chronic Low Back Pain: A Randomized Trial with One-year Follow-up
Clinical Rehabilitation 2010 (Jan); 24 (1): 2636
Cherkin, DC, Deyo, RA, Battie, M, Street, J, and Barlow, W.
A Comparison of Physical Therapy, Chiropractic Manipulation, and Provision of an Educational Booklet
for the Treatment of Patients with Low Back Pain
New England Journal of Medicine 1998 (Oct 8); 339 (15): 1021-1029
Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, et al.
A Clinical Prediction Rule To Identify Patients With Low Back Pain Most Likely To Benefit
from Spinal Manipulation: A Validation Study
Annals of Internal Medicine 2004 (Dec 21); 141 (12): 920928
Chown M, Whittamore L, Rush M, Allan S, Stott D, Archer M.
A prospective study of patients with chronic back pain randomised to group exercise, physiotherapy
Cleland J, Fritz J, Kulig K, Davenport TE, Eberhart S, Magel JS,
Comparison of the effectiveness of 3 manual physical therapy techniques in a subgroup of patients
with low back pain who satisfy a clinical prediction rule: a randomized clinical trial.
Journal of Orthopaedic and Sports Physical Therapy 2009;39(1):A16.
Cramer GD, Humphreys CR, Hondras MA, McGregor M, Triano
The Hmax/Mmax ratio as an outcome measure for acute low back pain.
J Manipulative Physiol Ther 1993;16(1):713.
Ferreira ML, Ferreira PH, Latimer J, et al.
Comparison of General Exercise, Motor Control Exercise and Spinal Manipulative Therapy
for Chronic Low Back Pain: A Randomized Trial
Pain. 2007 (Sep); 131 (1-2): 3137
Gibson T, Grahame R, Harkness J, Woo P, Blagrave P, Hills R.
Controlled comparison of short-wave diathermy treatment with osteopathic treatment in
non-specific low back pain.
Giles LG, Muller R.
Chronic Spinal Pain Syndromes: A Clinical Pilot Trial Comparing Acupuncture, A Nonsteroidal
Anti-inflammatory Drug, and Spinal Manipulation
J Manipulative Physiol Ther 1999 (Jul); 22 (6): 376381
Giles LG, Muller R.
Chronic Spinal Pain: A Randomized Clinical Trial Comparing Medication,
and Spinal Manipulation
Spine (Phila Pa 1976) 2003 (Jul 15); 28 (14): 14901502
Grunnesjo MI, Bogefeldt JP, Svardsudd KF, Blomberg SI.
A randomized controlled clinical trial of stay-active care versus manual therapy in addition to
stay-active care: functional variables and pain.
J Manipulative Physiol Ther 2004;27(7):43141.
Hallegraeff JM, de GM, Winters JC, Lucas C.
Manipulative therapy and clinical prediction criteria in treatment of acute nonspecific
low back pain.
Percept Mot Skills 2009;108(1): 196208.
Hoiriis KT, Pfleger B, McDuffie FC, Cotsonis G, Elsangak O, Hinson R, et al.
A Randomized Clinical Trial Comparing Chiropractic Adjustments to Muscle Relaxants
for Subacute Low Back Pain
J Manipulative Physiol Ther 2004 (Jul); 27 (6): 388-398
Hondras MA, Long CR, Cao Y, et al.
A Randomized Controlled Trial Comparing 2 Types of Spinal Manipulation and Minimal Conservative
Medical Care for Adults 55 Years and Older With Subacute or Chronic Low Back Pain
J Manipulative Physiol Ther. 2009 (Jun); 32 (5): 330343
Hough E, Stephenson R, Swift L.
A comparison of manual therapy and active rehabilitation in the treatment of non specific low
back pain with particular reference to a patient’s Linton & Hallden psychological
screening score: a pilot study.
BMC Musculoskelet Disord 2007;8: 106.106.
Hsieh CY, Adams AH, Tobis J, Hong CZ, Danielson C, Platt K,,
Effectiveness of four conservative treatments for subacute low back pain:
a randomized clinical trial.
Spine (Phila Pa 1976) 2002;27(11):114248.
Hsieh CY, Phillips RB, Adams AH, Pope MH.
Functional outcomes of low back pain: comparison of four treatment groups in a
randomized controlled trial.
J Manipulative Physiol Ther 1992;15(1):49.
Hurwitz EL, Morgenstern H, Harber P, Kominski GF, Belin TR, Yu F, Adams AH
A Randomized Trial of Medical Care with and without Physical Therapy and Chiropractic Care with
and without Physical Modalities for Patients with Low Back Pain:
6-month Follow-up Outcomes From the UCLA Low Back Pain Study
Spine (Phila Pa 1976) 2002 (Oct 15); 27 (20): 21932204
Juni P, Battaglia M, Nuesch E, Hammerle G, Eser P, van BR,
A randomised controlled trial of spinal manipulative therapy in acute low back pain.
Annals of the Rheumatic Diseases 2009;68(9):14201427.
Mandara, A, Fusaro, A, Musicco, M, and Bado, F.
A randomised controlled trial on the effectiveness of ostopathic manipulative treatment
of chronic low back pain.
Int J Osteopath Med 11, 156. 2008.
McMorland G, Suter E, Casha S, du Plessis SJ, Hurlbert RJ.
Manipulation or Microdiskectomy for Sciatica?
A Prospective Randomized Clinical Study
J Manipulative Physiol Ther. 2010 (Oct); 33 (8): 576584
Meade TW, Dyer S, Browne W, et al.
Low Back Pain of Mechanical Origin: Randomised Comparison of Chiropractic and Hospital Outpatient Treatment
British Medical Journal 1990 (Jun 2); 300 (6737): 14311437
Mohseni-Bandpei MA, Critchley J, Staunton T, Richardson B.
A prospective randomised controlled trial of spinal manipulation and utlrasound in the
treatment of chronic low back pain.
Manipulation in the treatment of acute low back pain.
The Journal of Manual and Manipulative Therapy 1999;7(4):18289.
Paatelma M, Kilpikoski S, Simonen R, Heinonen A, Alen M,
Orthopaedic manual therapy, McKenzie method or advice only for low back pain in working adults:
a randomized controlled trial with one year follow-up.
J Rehabil Med 2008;40(10):85863.
Rasmussen J, Laetgaard J, Lindecrona AL, Qvistgaard E, Bliddal
Manipulation does not add to the effect of extension exercises in chronic low-back pain (LBP).
A randomized, controlled, double blind study.
Joint Bone Spine 2008; 75(6):70813.
Senna M.K., Machaly S.A.
Does Maintained Spinal Manipulation Therapy for Chronic Non-specific Low Back Pain
Result in Better Long Term Outcome?
Spine (Phila Pa 1976) 2011 (Aug 15); 36 (18): 14271437
Skargren EI, Oberg BE, Carlsson PG, Gade M.
Cost and effectiveness analysis of chiropractic and physiotherapy treatment for low back and
neck pain. Six-month follow-up.
Spine (Phila Pa 1976) 1997;22(18):216777.
Wand BM, Bird C, McAuley JH, Dore CJ, MacDowell M, De
Early intervention for the management of acute low back pain: a single-blind randomized controlled
trial of biopsychosocial education, manual therapy, and exercise.
Spine (Phila Pa 1976) 2004;29(21):23502356.
Wilkey, A., Gregory, M., Byfield, D., and McCarthy, P.W.
A Comparison Between Chiropractic Management and Pain Clinic Management for Chronic
Low-back Pain in a National Health Service Outpatient Clinic
J Alternative and Complementary Med 2008 (Jun); 14 (5): 465473
Appendix B. Eighty-five articles that were excluded based on abstract
Chiropracters and low back pain.
Lancet 1990;336 (8709):220.
Longitudinal comparative study on the outcome of inpatient treatment of low back pain
with manual therapy vs physical therapy.
J Orthopaed Med 1995;17(1): 1014.
Apeldoorn AT, Ostelo RW, van HH, Fritz JM, de Vet HC, van
The cost-effectiveness of a treatment-based classification system for low back pain: design
of a randomised controlled trial and economic evaluation.
BMC Musculoskelet Disord 2010;11:58.58.
Axen I, Jones JJ, Rosenbaum A, Lovgren PW, Halasz L, Larsen K, et al.
The Nordic Back Pain Subpopulation Program: Validation and Improvement of a Predictive Model
for Treatment Outcome in Patients With Low Back Pain Receiving Chiropractic Treatment
J Manipulative Physiol Ther. 2005 (Jul); 28 (6): 381385
Axen I. et al.
The Nordic Back Pain Subpopulation Program: Can Patient Reactions to the First Chiropractic Treatment
Predict Early Favorable Treatment Outcome in Nonpersistent Low Back Pain?
J Manipulative Physiol Ther. 2005 (Mar); 28 (3): 153158
Axen I, Rosenbaum A, Robech R, Larsen K, Leboeuf-Yde C.
Can Patient Reactions to the First Chiropractic Treatment Predict Early Favorable Treatment Outcome
in Nonpersistent Low Back Pain?
J Manipulative Physiol Ther. 2002 (Sep); 25 (7): 450454
Bennell KL, Matthews B, Greig A, Briggs A, Kelly A, Sherburn
M, et al.
Effects of an exercise and manual therapy program on physical impairments, function and
quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind
controlled pilot trial.
BMC Musculoskelet Disord 2010;1136.
Boesler D, Warner M, Alpers A, Finnerty EP, Kilmore MA.
Efficacy of high-velocity low-amplitude manipulative technique in subjects with low-back pain
during menstrual cramping.
Journal of the American Osteopathic Association 1993; 93(2):2034.
Brealey S, Burton K, Coulton S, Farrin A, Garratt A, Harvey E,
UK Back Pain Exercise and Manipulation (UK BEAM) Trial--National Randomised Trial
of Physical Treatments for Back Pain in Primary Care: Objectives, Design and Interventions
BMC Health Serv Res. 2003 (Aug 1); 3 (1): 16
Brealey S, Burton K, Coulton S, Farrin A, Garratt A, Harvey E,
UK Back pain Exercise And Manipulation (UK BEAM) trial-national randomised trial of physical
treatments for back pain in primary care: objectives, design and interventions
BMC Health Serv Res 2003b; 3(1):16.
Low back pain: comparison of chiropractic and hospital outpatient treatment.
Effects of rotational mobilization versus sham mobilization of patients suffering
acute low back pain.
Aust J Physio 1988;35(1):60.
Effects of rotational mobilization versus sham mobilization of patients suffering
acute low back pain.
Aust J Physio 1989;35(1):60.
Carey TS, Garrett J, Jackman A, et al.
The Outcomes and Costs of Care for Acute Low Back Pain Among Patients
Seen by Primary Care Practitioners, Chiropractors, and Orthopedic Surgeons
New England J Medicine 1995 (Oct 5); 333 (14): 913917
Cherkin DC, Deyo RA, Battie M, Street J, Barlow W.
Chiropractic manipulation and McKenzie physiotherapy were not effective for low back pain.
ACP Journal Club 1999;42.
Does the choice of spinal level treated during posteroanterior (PA) mobilization affect
Physiotherapy Theroy and Practice 2002; 18(4):16574.
Cibulka MT, Delitto A, Koldehoff RM.
Changes in innominate tilt after manipulation of the sacroiliac joint in patients with
low back pain. An experimental study.
Phys Ther 1988;68(9):135963.
Cleland JA, Fritz JM, Childs JD, Kulig K.
Comparison of the effectiveness of three manual physical therapy techniques in a subgroup
of patients with low back pain who satisfy a clinical prediction rule:
study protocol of a randomized clinical trial
BMC Musculoskelet Disord 2006;7:11.11.
Cooperstein R, Perle SM, Gatterman MI, Lantz C, Schneider
Chiropractic technique procedures for specific low back conditions:
characterizing the literature.
J Manipulative Physiol Ther 2001;24(6):40724.
A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative
medical care for adults 55 years and older with subacute or chronic low back pain.
J Manipulative Physiol Ther 2009; 32(7):601.
Cramer GD, Gregerson DM, Knudsen JT, Hubbard BB, Ustas
LM, Cantu JA.
The effects of side-posture positioning and spinal adjusting on the lumbar Z joints:
a randomized controlled trial with sixty-four subjects.
Spine (Phila Pa 1976) 2002;27(22):245966.
Cramer GD, Tuck NR, Jr., Knudsen JT, Fonda SD, Schliesser JS,
Fournier JT, et al.
Effects of side-posture positioning and side-posture adjusting on the lumbar zygapophysial
joints as evaluated by magnetic resonance imaging: a before and after study with randomization.
J Manipulative Physiol Ther 2000;23(6):380394.
Descarreaux M, Blouin JS, Drolet M, Papadimitriou S, Teasdale N:
Efficacy of Preventive Spinal Manipulation for Chronic Low-Back Pain and Related Disabilities:
A Preliminary Study
J Manipulative Physiol Ther 2004 (Oct); 27 (8): 509514
Evans DW, Foster NE, Underwood M, Vogel S, Breen AC, Pincus
Testing the effectiveness of an innovative information package on practitioner reported behavior
and beliefs: the UK Chiropractors, Osteopaths and Musculoskeletal Physiotherapists
Low back pain ManagemENT (COMPLeMENT) trial
BMC Musculoskelet Disord 2005;641.
Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D. et al.
A Clinical Prediction Rule for Classifying Patients with Low Back Pain
who Demonstrate Short-term Improvement with Spinal Manipulation
Spine (Phila Pa 1976). 2002 (Dec 15); 27 (24): 28352843
French SD, Green S, Forbes A.
Reliability of chiropractic methods commonly used to detect manipulable lesions in patients
with chronic low-back pain.
J Manipulative Physiol Ther 2000;23(4):23138.
Fritz JM, Whitman JM, Flynn TW, Wainner RS, Childs JD.
Factors related to the inability of individuals with low back pain to improve with a
Phys Ther 2004;84(2):17390.
Geisser ME, Wiggert EA, Haig AJ, Colwell MO.
A randomized, controlled trial of manual therapy and specific adjuvant exercise for
chronic low back pain.
Clin J Pain 2005;21(6):46370.
Treatment of chronic low-back pain with low force manipulation.
Chiroprac J Aust 1992;22(2): 5460.
Study to evaluate manipulation therapy.
Haas M, Goldberg B, Aickin M, Ganger B, Attwood M.
A Practice-Based Study of Patients With Acute and Chronic Low Back Pain Attending
Primary Care and Chiropractic Physicians: Two-Week to 48-Month Follow-up
J Manipulative Physiol Ther 2004 (Mar); 27 (3): 160169
Haas M, Sharma R, Stano M.
Cost-effectiveness of Medical and Chiropractic Care for Acute and Chronic Low Back Pain
J Manipulative Physiol Ther 2005 (Oct); 28 (8): 555563
Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW,
Day RO, et al.
Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized
BMC Musculoskelet Disord 2005; 657.
Harvey E, Burton AK, Moffett JK, Breen A.
Spinal manipulation for low-back pain: a treatment package agreed to by the UK chiropractic,
osteopathy and physiotherapy professional associations.
Man Ther 2003;8(1):4651.
Hawk C, Phongphua C, Bleecker J, Swank L, Lopez D, Rubley T.
Preliminary study of the reliability of assessment procedures for indications for
chiropractic adjustments of the lumbar spine.
J Manipulative Physiol Ther 1999;22(6):382 89.
Hemmila HM, Keinanen-Kiukaanniemi SM, Levoska S, Puska P.
Does folk medicine work? A randomized clinical trial on patients with prolonged back pain.
Arch Phys Med Rehabil 1997;78(6):57177.
Hemmila HM, Keinanen-Kiukaanniemi SM, Levoska S, Puska P.
Long-term effectiveness of bone-setting, light exercise therapy, and physiotherapy for
prolonged back pain: a randomized controlled trial.
J Manipulative Physiol Ther 2002;25(2):99104.
Henchoz Y, de GP, Norberg M, Paillex R, So AK.
Role of physical exercise in low back pain rehabilitation: a randomized controlled trial of
a three-month exercise program in patients who have completed multidisciplinary rehabilitation.
Spine (Phila Pa 1976) 2010;35(12): 119299.
Heymans MW, Anema JR, de Vet HC, van MW.
Does flexiondistraction help treat chronic low back pain?
Nat Clin Pract Rheumatol 2006;2(7):360361.
Hildebrandt J, Pfingsten M, Saur P, Jansen J.
Prediction of success from a multidisciplinary treatment program for chronic low back pain.
Spine (Phila Pa 1976) 1997;22(9): 9901001.
Hoskins W, Pollard H.
The effect of a sports chiropractic manual therapy intervention on the prevention of back pain,
hamstring and lower limb injuries in semi-elite Australian Rules footballers:
a randomized controlled trial.
BMC Musculoskelet Disord 2010;11:64.64.
Jayson MI, Sims-Williams H, Young S, Baddeley H, Collins E.
Mobilization and manipulation for low-back pain.
Spine (Phila Pa 1976) 1981;6(4):40916.
Kane RL, Olsen D, Leymaster C, Woolley FR, Fisher FD.
Manipulating the patient. A comparison of the effectiveness of physician and chiropractor care.
Koes BW, Bouter LM, Knipschild PG, van Mameren H, Houben JP, Verstegen G.
The effectiveness of manual therapy, physical therapy and continued treatment by the
general practitioner for back and neck complaints.
Aust Physio 1990;36(3):191.
Koes BW, Bouter LM, Knipshild PG, van MH, Essers A, Houben JP, et al.
The effectiveness of manual therapy, physiotherapy and continued treatment by the general
practitioner for chronic nonspecific back and neck complaints:
design of a randomized clinical trial.
J Manipulative Physiol Ther 1991;14(9):498502.
Kohlbeck FJ, Haldeman S, Hurwitz EL, Dagenais S.
Supplemental care with medication-assisted manipulation versus spinal manipulation therapy
alone for patients with chronic low back pain.
J Manipulative Physiol Ther 2005;28(4):24552.
Kokjohn K, Schmid DM, Triano JJ, Brennan PC.
The effect of spinal manipulation on pain and prostaglandin levels in women with
J Manipulative Physiol Ther 1992;15(5):27985.
Koldas DS, Sonel TB, Kurtais Y, Atay MB.
Comparison of three different approaches in the treatment of chronic low back pain.
Clin Rheumatol 2008;27(7):87381.
Laird R, Hughes P.
Manipulative therapy and back care education: a comparative trial of two treatment methods.
Aust J Physio 1988;34(1):55.
Leboeuf-Yde C, Axen I, Jones JJ, Rosenbaum A, Lovgren PW, Halasz L, Larsen K:
The Nordic Back Pain Subpopulation Program: The Long-term Outcome Pattern in Patients
With Low Back Pain Treated by Chiropractors in Sweden
J Manipulative Physiol Ther. 2005 (Sep); 27 (7): 472478
Leboeuf-Yde C, Gronstvedt A, Borge JA, Lothe J, Magnesen E, Nilsson O, et al.
The Nordic Back Pain Subpopulation Program: Demographic and Clinical Predictors for Outcome
in Patients Receiving Chiropractic Treatment for Persistent LowBack Pain
J Manipulative Physiol Ther. 2004 (Oct); 27 (8): 493502
Leboeuf-Yde C, Grψnstvedt A, Borge JA, Lothe J, Magnesen E, Nilsson Ψ, Rψsok G, Stig LC, Larsen K:
The Nordic Back Pain Subpopulation Program: A 1-year Prospective Multicenter Study of Outcomes of
Persistent Low-back Pain in Chiropractic Patients
J Manipulative Physiol Ther. 2005 (Feb); 28 (2): 9096
Licciardone JC, Buchanan S, Hensel KL, King HH, Fulda KG, Stoll ST.
Osteopathic manipulative treatment of back pain and related symptoms during pregnancy:
a randomized controlled trial.
Am J Obstet Gynecol 2010;202(1):4348.
Maiers M, Hartvigsen J, Schulz C, Schulz K, Evans R, Bronfort G.
Chiropractic and Exercise for Seniors With Low Back Pain or Neck Pain:
The Design of Two Randomized Clinical Trials
BMC Musculoskelet Disord. 2007 (Sep 18); 8: 94
Martin PR, Rose MJ, Nichols PJ, Russell PL, Hughes IG.
Physiotherapy exercises for low back pain: process and clinical outcome.
International Rehabilitation Medicine 1986;8(1):3438.
Mayer TG, Gatchel RJ, Keeley J, McGeary D, Dersh J, Anagnostis C.
A randomized clinical trial of treatment for lumbar segmental rigidity.
Spine (Phila Pa 1976) 2004;29(20): 2199205.
Effectiveness of chiropractic and physiotherapy in the treatment of low back pain.
A critical discussion of the British Randomized Clinical Trial.
J Manipulative Physiol Ther 1991;14(7):44446.
Moffett JA, Frost H.
Back to fitness programme: the manual for physiotherapists to set up the classes.
Physio 2000;86(6): 295305.
Manual therapy and exercise therapy in patients with chronic low back pain:
a randomized, controlled trial with 1-year follow-up.
Spine (Phila Pa 1976) 2004;29(1): 1078.
Nyiendo J, Haas M, Goodwin P.
Patient characteristics, practice activities, and one-month outcomes for chronic,
recurrent low-back pain treated by chiropractors and family medicine physicians:
a practice-based feasibility study.
J Manipulative Physiol Ther 2000;23(4): 23945.
Rainbow DM, Weston JP, Brantingham JW, Globe G, Lee F.
A prospective clinical trial comparing chiropractic manipulation and exercise therapy
vs. chiropractic mobilization and exercise therarpy for treatment of patients suffering
from adhesive capsulitis/frozen shoulder.
J Am Chiroprac Assoc 2008;1228.
Rasmussen-Barr E, Nilsson-Wikmar L, Arvidsson I.
Stabilizing training compared with manual treatment in subacute and chronic low-back pain.
Man Ther 2003;8(4): 23341.
Ritvanen T, Zaproudina N, Nissen M, Leinonen V, Hanninen O.
Dynamic surface electromyographic responses in chronic low back pain treated by traditional
bone setting and conventional physical therapy.
J Manipulative Physiol Ther 2007;30(1):3137.
Roy RA, Boucher JP, Comtois AS.
Heart rate variability modulation after manipulation in pain-free patients vs patients in pain.
Manipulative Physiol Ther 2009;32(4):27786.
Rupert RL, McKinzie CL, Morter MT, Jr., Daniel DM.
Treatment of chronic nonresponsive patients with a nonforce technique.
J Manipulative Physiol Ther 2005;28(4): 25964.
Schellingerhout JM, Verhagen AP, Heymans MW, Pool JJ, Vonk F, Koes BW, et al.
Which subgroups of patients with non-specific neck pain are more likely to benefit from
spinal manipulation therapy, physiotherapy, or usual care?
Schenk P, Laeubli T, Klipstein A.
Validity of pressure pain thresholds in female workers with and without recurrent
low back pain.
Eur Spine J 2007;16(2):26775.
Schimmel JJ, de KM, Horsting PP, Spruit M, Jacobs WC, van LJ.
No effect of traction in patients with low back pain: a single centre, single blind,
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E Spine J 2009;18(12):184350.
Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A.
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J Manipulative Physiol Ther 2010;33(3):193200.
Sheahan PA, Seaton TL.
Alternative therapy for low back pain.
Journal of Family Practice 1999;48(1): 1011.
Shekelle PG, Adams AH, Chassin MR, Hurwitz EL, Brook RH.
Spinal manipulation for low-back pain.
Ann Intern Med 1992;117(7):590598.
Shekelle PG, Markovich M, Louie R.
Factors associated with choosing a chiropractor for episodes of back pain care.
Med Care 1995;33(8):84250.
Sherman, KJ, Cherkin, DC, Connelly, MT, Erro, J, Savetsky, JB, Davis, RB et al.
Complementary and Alternative Medical Therapies for Chronic Low Back Pain:
What Treatments Are Patients Willing To Try?
BMC Complement Altern Med. 2004 (Jul 19); 4: 9
A randomized clinical trial of manual therapy and physiotherapy for persistent back and
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J Manipulative Physiol Ther 1994;17(2):128.
Skillgate E, Bohman T, Holm LW, Vingard E, Alfredsson L.
The long-term effects of naprapathic manual therapy on back and neck pain -
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Skillgate E, Vingard E, Alfredsson L.
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Preventing progression to chronicity in first onset, subacute low back pain:
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Arch Phys Med Rehabil 2009;90(4):54552.
Smith DL, Dainoff MJ, Smith JP.
The effect of chiropractic adjustments on movement time: a pilot study using Fitts Law.
J Manipulative Physiol Ther 2006;29(4):25766.
Snyder BJ, Zhang J.
Toftness system of chiropractic adjusting on pain syndromes:
a pilot study in a multicenter setting.
J Chiropr Med 2007;6(1):1519.
Stern PJ, Cote P, Cassidy JD.
A series of consecutive cases of low back pain with radiating leg pain treated by chiropractors.
J Manipulative Physiol Ther 1995;18(6):33542.
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A randomized controlled trial of the effects of instrumentapplied cervical manipulative
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J Manipulative Physiol Ther 2006; 29(4):26774.
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Why do spinal manipulation techniques take the form they do?
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van Tulder MW, Assendelft WJ, Koes BW, Bouter LM.
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van Tulder MW, Koes B.
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Cochrane Database Syst Rev 2010(4):CD005427.
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