NASS Contemporary Concepts in Spine Care:
Spinal Manipulation Therapy for Acute Low Back PainThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Spine J. 2010 (Oct); 10 (10): 91840 ~ FULL TEXT
Simon Dagenais DC, PhD, Ralph E. Gay DC, MD, Andrea C. Tricco PhD,
Michael D. Freeman PhD, MPH, DC and John M. Mayer DC, PhD
Palladian Health,
2732 Transit Rd, West Seneca, NY 14224, USA.
simon@spine-research.com
This issue of The Spine Journal includes a review of the scientific evidence supporting spinal manipulative therapy (SMT) for low back pain. The results were quite favorable and reflect a growing body of evidence supporting SMT over medications and other conservative options. SMT research demonstrates equivalent or superior improvement in pain and function when compared with other commonly used interventions, such as physical modalities, medication, education, or exercise, for short, intermediate, and long-term follow-up. The authors conclude by recommending that other health care providers consider SMT as a viable option if self care or education fails to provide pain relief.
Another review of national and international guidelines, published Dec 2010 by Koes et. al. pointed out the disparities between guidelines with respect to spinal manipulation and the use of drugs for both chronic and acute low back pain.
Another review of guidelines published in June 2010 also noted a great degree of similarity between guidelines and that Recommendations for management of acute LBP emphasized patient education, with short-term use of acetaminophen, nonsteroidal anti-inflammatory drugs, or spinal manipulation therapy.
Although there is always a need for more evidence, the evidence over the last few years is providing much stronger support for SMT and that evidence is slowly finding its way into major clinical guidelines both in the United States and internationally.
The Abstract
BACKGROUND CONTEXT: Low back pain (LBP) continues to be a very prevalent, disabling, and costly spinal disorder. Numerous interventions are routinely used for symptoms of acute LBP. One of the most common approaches is spinal manipulation therapy (SMT).
PURPOSE: To assess the current scientific literature related to SMT for acute LBP.
PATIENT SAMPLE: Not applicable.
OUTCOME MEASURES: Not applicable.
DESIGN: Systematic review (SR).
METHODS: Literature was identified by searching MEDLINE using indexed and free text terms. Studies were included if they were randomized controlled trials (RCTs) published in English, and SMT was administered to a group of patients with LBP of less than 3 months. RCTs included in two previous SRs were also screened, as were reference lists of included studies. Combined search results were screened for relevance by two reviewers. Data related to methods, risk of bias, harms, and results were abstracted independently by two reviewers.
RESULTS: The MEDLINE search returned 699 studies, of which six were included; an additional eight studies were identified from two previous SRs. There were 2,027 participants in the 14 included RCTs, which combined SMT with education (n=5), mobilization (MOB) (n=4), exercise (n=3), modalities (n=3), or medication (n=2). The groups that received SMT were most commonly compared with those receiving physical modalities (n=7), education (n=6), medication (n=5), exercise (n=5), MOB (n=3), or sham SMT (n=2). The most common providers of SMT were chiropractors (n=5) and physical therapists (n=5). Most studies (n=6) administered 5 to 10 sessions of SMT over 2 to 4 weeks for acute LBP. Outcomes measured included pain (n=10), function (n=10), health-care utilization (n=6), and global effect (n=5). Studies had a follow-up of less than 1 month (n=7), 3 months (n=1), 6 months (n=3), 1 year (n=2), or 2 years (n=1). When compared with various control groups, results for improvement in pain in the SMT groups were superior in three RCTs and equivalent in three RCTs in the short term, equivalent in four RCTs in the intermediate term, and equivalent in two RCTs in the long term. For improvement in function, results from the SMT groups were superior in one RCT and equivalent in four RCTs in the short term, superior in one RCT and equivalent in one RCT in the intermediate term, and equivalent in one RCT and inferior in one RCT in the long term. No harms related to SMT were reported in these RCTs.
CONCLUSIONS: Several RCTs have been conducted to assess the efficacy of SMT for acute LBP using various methods. Results from most studies suggest that 5 to 10 sessions of SMT administered over 2 to 4 weeks achieve equivalent or superior improvement in pain and function when compared with other commonly used interventions, such as physical modalities, medication, education, or exercise, for short, intermediate, and long-term follow-up. Spine care clinicians should discuss the role of SMT as a treatment option for patients with acute LBP who do not find adequate symptomatic relief with self-care and education alone.
From the FULL TEXT Article:
Introduction
Low back pain (LBP) is a common and often disabling condition. The cumulative 1-year incidence of LBP is approximately 20% [1, 2], with most initial episodes being mild [2]. The reported prevalence of LBP varies greatly. The point prevalence ranges from 6% to 33% [3, 4] and the 1-year prevalence from 22% to 65% [4]. The lifetime prevalence of LBP is even more variable, likely because of differences in the definitions of LBP used, the populations studied, and the study methodology [5]. There has been a recent effort to promote a common definition of LBP that will allow comparisons to be made between studies [6].
Low back pain is commonly classified as acute (<3 months) or chronic (>3 months) based on its duration [7]. These temporal definitions appear to be based on studies that showed that almost all persons with LBP returned to work within 90 days [8, 9]. Although acute LBP does tend to improve with time and generally has a good prognosis, improvement in pain and disability does not correlate well with return-to-work rates [10]. Furthermore, recent studies have shown that a significant proportion of acute LBP sufferers will develop recurrent or chronic LBP. A survey of persons 35 to 45 years old found that LBP resolved quickly in only 27% of subjects, whereas 40% developed persistent LBP [5]. Even among those whose LBP had initially resolved, 29% had recurrent (usually mild) LBP within 6 months [5]. Other studies have found similar trends for recurrence of LBP [2, 11]. Although it is difficult to predict who among those with first episodes of LBP will develop recurrent or chronic symptoms, factors related to the determinants of disability and to the prediction of chronic disability appear by 14 days after the onset of pain, supporting that as a cutoff point in the transition from acute to subacute pain [12]. Psychological factors appear to play an important role in that transition and related disability [13].
Low back pain is a significant societal burden. Persons seeking care for LBP constitute a substantial proportion of patients seen in primary care offices. Direct and indirect costs for LBP have been reported in studies from many countries, but differences in methodology make it difficult to compare the results. A recent review suggested that, although the total yearly cost of LBP (direct and indirect costs) in the United States has been reported to be between $19.6 and $118.8 billion per year, the true cost may be much higher [14].
Much can be learned from a brief but thorough history and examination of patients with LBP. Clinical practice guidelines from the United States and various European groups suggest that, in the absence of any red flags for serious spinal pathology, advanced diagnostic studies are not needed in the initial evaluation of acute LBP [15, 16]. Red flags for LBP are symptoms, findings, or other characteristics that may be indicative of rare but potentially serious spinal pathology, such as spinal tumor, infection, fracture, or cord compromise [17]. Examples of red flags include unexplained weight loss, loss of bowel or bladder function, saddle anesthesia, widespread neurologic symptoms in the lower extremities, recent trauma with osteoporosis or prolonged corticosteroid use, immune suppression, and systemic unwellness [17]. Such an evaluation should be based on the symptoms of the patient and the diagnostic concerns of the physician but may include X-ray; advanced imaging (bone scan, computed tomography, or magnetic resonance imaging); laboratory studies; or electrophysiological studies.
In most cases of acute LBP, an objective cause cannot be found. Such cases are, therefore, described as nonspecific. Despite this lack of knowledge regarding the etiology of LBP, there are many interventions available, and many providers who are willing to use them [18]. The providers training often biases the choice of treatment for acute LBP. Common primary care approaches include education, reassurance, return to activities, nonsteroidal antiinflammatory drugs (NSAIDs), and simple analgesics. Patients with acute LBP who do not improve quickly often seek additional care from both surgical and nonsurgical specialists. One of the most common treatments used in North America and Europe is spinal manipulation therapy (SMT) [19]. Practitioners have used some form of SMT to treat LBP for thousands of years [20].
In North America, SMT is usually provided by Doctors of Chiropractic (DCs) [21]. However, in other countries, particularly in Europe and Australia, it is commonly used by physical therapists (PTs), Doctors of Osteopathy (DOs), and medical doctors (MDs) trained in manual therapy. How SMT works is not completely understood, but there is growing evidence that its effects result from a combination of mechanical, neurological, and biochemical changes in various structures [19]. Like many therapies administered for acute LBP, SMT has a diminishing effect size as the duration of follow-up increases. As a result, its clinical efficacy for acute LBP is still debated despite many randomized controlled trials (RCTs), systematic reviews (SRs), and meta-analyses.
The North American Spine Society (NASS) Contemporary Concepts are a series of evidence-based reviews of contemporary issues in spine care, intended to provide spine clinicians with a general understanding about current practices. Because of the uncertainty of the role of SMT in the care of acute LBP within the community of spine care providers at large, a Complementary Medicine Task Force composed of NASS members (primarily members of the former NASS Complementary Medicine Committee, see Acknowledgments) was appointed to develop a Contemporary Concepts article on SMT for acute LBP.
Methods
Eligibility criteria
The eligibility criteria were based on the Population, Intervention, Control, Outcomes, Study design (PICOS) principle [22] as follows:Population: adults with acute LBP (ie, pain lasting <12 weeks);
Intervention: SMT or mobilization (MOB);
Control: any control group that did not receive SMT or MOB or allowed for evaluation of the comparative efficacy of different forms of SMT or MOB;
Outcomes: patient-reported pain reduction and functional improvement (primary outcomes), as well as global effect, health-care utilization, and harms (secondary outcomes);
Study design: limited to RCTsOnly RCTs published in English were eligible for inclusion. RCTs were excluded if most of the participants had symptoms for more than 12 weeks, the study design did not permit isolating the effects of SMT (or MOB), SMT was nonforce, participants had multiple indications and only combined results were reported, studies had fewer than 20 participants enrolled in each study group, or follow-up was less than 1 week after the last intervention.
Information sources
Randomized controlled trials were identified through an electronic search of MEDLINE (OVID Interface) on January 13, 2009, and screening the reference lists of two previous SRs on this topic [23, 24].
Search
MEDLINE was searched using strategies that were validated by the Cochrane Back Review Group (CBRG) to identify RCTs (part A of the search strategy) related to spinal disorders (parts B and D), which were combined with search terms related to SMT (Table 1) [25]. The following limits were applied to the search results in OVID: 1) articles published in English; 2) related to adult participants; 3) published from 1999 to 2009; and 4) abstracts available for screening.
Study selection
Two reviewers independently screened the search results using predefined inclusion and exclusion criteria. Reviewers discussed disagreements until consensus was reached. Full-text articles were retrieved for all citations deemed relevant or of uncertain relevance to confirm their eligibility. Reasons for excluding the retrieved full-text articles were noted.
Data collection process
One reviewer used a predefined data extraction instrument to extract the data from the included RCTs. Another reviewer subsequently verified the data to ensure accuracy.
Data items
The main categories of data abstracted for included studies were methods, pain outcome results, functional outcome results, other outcome results (eg, global effect, health-care utilization), and harms.
For methods, the following items were abstracted:1) study setting and population;
2) inclusion criteria;
3) exclusion criteria;
4) description of intervention(s), provider, and regimen (eg, frequency, duration) received by experimental group;
5) description of intervention(s), provider, and regimen (eg, frequency, duration) received by control group(s);
6) number of participants enrolled in experimental group;
7) number of participants enrolled in control group(s);
8) outcome measures and follow-up points.
For pain, functional, and other outcome results, the following data were abstracted:1) group means at baseline and each follow-up point and
2) statistical significance of intra- and intergroup differences at baseline and each follow-up point.
For harms, the following data were abstracted:1) type of adverse event,
2) number of adverse events occurring in the intervention group, and
3) number of adverse events occurring in the control group(s).
Risk of bias
To assess the possibility of bias in the results of the included RCTs, methodological quality was assessed according to a tool developed by the CBRG [7]. The tool includes 12 criteria that assess different aspects of bias, and each must be scored as yes/no/unsure; RCTs scoring 6 or higher and without serious flaws were deemed to be of higher methodological quality [7]. Two reviewers assessed the risk of bias in the included studies independently. Conflicts between reviewers were discussed until consensus was achieved. The clinical relevance of RCTs was also assessed descriptively according to whether the study protocols reflected common clinical practice for the application of SMT for acute LBP.
Synthesis of results
Results related to pain, function, global effect, healthcare utilization, and other outcomes were synthesized separately according to whether the experimental group that received SMT (or MOB) was superior, equal, or inferior to the control group, as determined by between-group statistical significance (p<.05) reported in the studies at each follow-up point. Results were summarized by duration of follow-up, with less than 4 weeks considered short term, 1 to 6 months considered intermediate term, and more than 6 months considered long term. Pain and functional outcomes were converted to a 0 to 100 scale, and percent improvement from baseline was calculated for each follow-up point. If multiple studies reported results for pain or function at similar follow-up points within each category of duration (eg, 12, 34 weeks), the mean and standard deviation (SD) for improvement from baseline were calculated for the experimental groups and control groups. If a study reported results for multiple, similar follow-ups (eg, 1 and 2 weeks), only results for the longest duration within that timeframe were included in the synthesis. If studies reported multiple outcome measures for pain (eg, visual analog scale [VAS] and McGill Pain Questionnaire) or function (eg, Roland-Morris Disability Questionnaire [RMDQ] and Oswestry Disability Index [ODI]), results from all outcome measures reported were included in the synthesis. Results for outcomes other than pain or function were synthesized descriptively.
Risk of bias across studies
The risk of bias across studies was assessed using the outcome-reporting bias item of the CBRG tool.
Results
Search
The MEDLINE search resulted in 699 citations, of which eight were deemed potentially relevant [2633], and 11 were of uncertain relevance [3444]. After screening full-text articles for those 19 studies, only six were deemed eligible [26, 28, 29, 3133]. Reasons for excluding full-text articles included duplicate reports (n = 8) [3438, 4042], less than 20 participants per study group (n = 1) [27], not being able to distinguish separate effects of multimodal intervention (n = 1) [30], mixed neck and back pain (n = 1) [44], no patient-reported outcomes (n = 1) [39], and no acute LBP (n = 1) [43] (Figure). An additional eight eligible studies [4552] were identified from two previous SRs on similar topics [23, 53]. A total of 14 studies were, therefore, included in this review [26, 28, 29, 3133, 4552]; only one study was published in a journal not indexed in MEDLINE [52]. These studies were published between 1974 and 2006, including one in the 1970s [47], five in the 1980s [46, 48, 49, 51, 52], three in the 1990s [26, 45, 50], and five in the 2000s [28, 29, 3133]. These studies originated in five countries, including Australia [29, 46], Canada [48], Italy [33, 52], United Kingdom [32, 47, 50, 51], and the United States [26, 28, 31, 45, 49]. Study participants were recruited from primary care settings (n = 6), outpatient medical centers (n = 3), PT centers (n = 2), employees of a company (n = 1), or unclear settings (n = 2). The full study descriptions can be found in Table 2.
Indication
Acute LBP was defined using both a minimum duration (n = 4), ranging from 1 to 4 weeks, and a maximum duration (n = 5), ranging from 3 weeks to 6 months. All studies enrolled participants with less than 12 weeks of symptoms, consistent with parameters set by the CBRG [7]. Only one study specified that participants were required to have LBP amenable to SMT to enroll [48]. The number of exclusion criteria reported ranged from 2 to 15, and the most common was severe disease (n = 13), followed by nerve root compression/neurological symptoms (n = 11), pregnancy (n = 8), prior lumbar surgery (n = 6), systemic inflammation (n = 5), active litigation/workers compensation (n = 5), current treatment for LBP (n = 5), mild severity (n = 5), prior SMT (n = 4), and psychological illness (n = 3).
Experimental group
The experimental group received some form of SMT, including high-velocity or low-amplitude (HVLA; ie, manual thrusts pushing the spinal joints slightly beyond their passive range of motion [19]) (n = 6) [26, 28, 33, 45, 49, 50]; rotational (ie, an HVLA technique involving rotating the patients thigh and leg [19]) (n = 3) [47, 48, 51]; HVLA or MOB (ie, manual force to the spinal joints not involving a thrust or pushing them beyond their passive range of motion [19]) (n = 2) [29, 32]; instrument (n = 1) [31]; MOB (n = 1) [46]; or unspecified (n = 1) [52]. There were two experimental groups that received the intervention of interest (eg, SMT) in two of the included studies [29, 32]. The number of study treatments in the experimental groups ranged from 1 to 20 sessions delivered over 1 to 12 weeks, with most studies providing 5 to 10 sessions [26, 28, 31, 32, 4547, 49] over 2 to 4 weeks [28, 29, 31, 33, 45, 46, 51, 52]. A DC (n = 5) or PT (n = 5) most frequently administered SMT, although some studies used a DO (n = 2) or MD (n = 2); it was unclear who the provider was in one study (n = 1). The number of participants enrolled in the experimental groups at baseline ranged from 21 to 165, with a mean of 63.1 and an SD (6) of 38.1; overall, a total of 1,009 participants received SMT across these 14 studies.
Control group
Studies most frequently had one control group (n = 10), though some had two (n = 3) or even four (n = 1) control groups against which SMT was compared. The most common intervention given to the control groups was physical modalities (eg, ultrasound, transcutaneous electrical nerve stimulation, heat, ice) (n = 7), followed by medication (eg, NSAIDs, muscle relaxants, acetaminophen) (n = 5); education (n = 6); exercise (eg, strengthening, aerobic, stretching) (n = 5); MOB (n = 3); and sham SMT (n = 2). Other interventions as controls to SMT included lumbar supports, sham physical modalities (eg, detuned diathermy), placebo medication, and bed rest. The number of treatment sessions and duration of treatment in the experimental groups generally mirrored those in the experimental groups (eg, 510 sessions over 24 weeks). The most common type of provider in the control groups was PT (n = 8), followed by MD (n = 5), DC (n = 2), and others (n = 1). The total number of participants enrolled in control groups was higher than in experimental groups at 1,018, ranging from 23 to 133, with a mean of 53.6±31.6.
Methodological quality
The methodological quality results can be found in Table 3. The number of criteria met by RCTs varied from 3 to 11, with a mean of 6.6±2.4. Nine RCTs met six or more items [26, 28, 29, 3133, 45, 47, 49], but two had high dropouts [31, 32]. There were seven RCTs of higher methodological quality that met 8.1±2.0 criteria [26, 28, 29, 33, 45, 47, 49] and seven RCTs of lower methodological quality that met 5.161.8 criteria [31, 32, 46, 48, 5052]. The quality criterion most commonly fulfilled was no selective outcome reporting (n = 14), followed by groups similar at baseline (n = 13), having similar timing of outcome assessment (n = 12), blinding of outcome assessor (n = 10), acceptable dropout (n = 10), adequate randomization (n = 7), intention-to-treat analysis (n = 7), treatment allocation concealment (n = 5), patient blinded (n = 5), similar cointerventions (n = 5), and acceptable compliance (n = 5).
Pain
The results for the pain outcomes can be found in Table 4. Six RCTs reported pain outcomes using the VAS [26, 3133] or numerical rating scale [45, 46]; one study reported pain relief (%) without raw data [47]. Baseline pain scores in the experimental groups had a mean of 51.8±4.1; baseline scores were similar in the control groups (48.4±6.6). Five studies [31, 33, 4547] reported pain reduction after 1 to 2 weeks of 38±13% in the experimental groups and 34±19% in control groups; this difference was statistically significant in two studies [31, 33]. Four studies [31, 33, 45, 46] reported pain reduction after 3 to 4 weeks of 66±17% in the experimental groups and 50±22% in control groups; this difference was statistically significant in one study [45]. Four studies [26, 32, 33, 45] reported pain reduction after 2 to 3 months of 57±13% in the experimental groups and 46±10% in control groups; this difference was statistically significant in one study [45].
Two studies [32, 33] reported pain reduction after 6 months of 47±19% in the experimental groups and 46±1% in control groups; these differences were not statistically significant. Two studies [32, 45] reported pain reduction after 1 year of 51±16% in the experimental groups and 55±9% in control groups; these differences were not statistically significant. One study [45] reported pain reduction after 2 years of 71±0.0% in the experimental group and 60±10% in the control groups; this difference was not statistically significant. Other outcomes related to pain included LBP recurrence [32, 45], which was 63.5±19.1% in experimental groups and 58.3±9.7% in control groups after 1 year and 70±0.0% in both groups after 2 years, and participants recovered from symptoms [29, 33, 51], whose values were 40.5±31.5% in the experimental groups and 37.8±31.3% in the control groups after 2 to 4 weeks; 26.0±2.8% and 6.0±0.0%, respectively, after 3 to 6 months (this difference was statistically significant); and 46.5±2.1% and 32.5±6.4%, respectively, after 1 year.
Function
The functional outcome results can be found in Table 5. Nine RCTs reported functional outcomes using the RMDQ [26, 29, 32, 45, 49], ODI [26, 28, 31], Short-Form 36 (SF-36) physical function [32, 33], or other outcome measures [29, 50]; one reported only the statistical significance of differences without raw data [29]. Some studies reported multiple functional outcomes [26, 29, 32], and others reported functional outcome results for multiple subgroups [49, 50]. Baseline RMDQ scores from five experimental groups had a mean of 43.3 and an SD of 8.1; baseline scores were similar in seven control groups (mean±SD = 43.5±8.6). Baseline ODI scores from three experimental groups had a mean of 60.7±18.5; scores were similar in four control groups (56.0±17.4). Five studies [28, 31, 45, 49, 50] reported functional improvement in the experimental groups of 53±15% after 1 to 2 weeks and 44±22% in the control groups; this difference was statistically significant in one study [28]. Four studies [28, 31, 45, 50] reported functional improvement after 3 to 4 weeks of 55±7% in the experimental groups and 55±21% in control groups; this difference was statistically significant in one study [28]. Three studies [26, 32, 45] reported functional improvement after 2 to 3 months of 51±21% in the experimental groups and 58±23% in the control groups; these differences were not statistically significant.
Two studies [28, 32] reported functional improvement after 6 months of 44±22% in the experimental groups and 38621% in the control groups; this difference was statistically significant in one study [28]. Two studies [32, 45] reported functional improvement after 1 year of 43±23% in the experimental groups and 49±25% in the control groups; this difference was statistically significant in one study [32]. One study [45] reported functional improvement after 2 years of 7560% in the experimental group and 69±9% in the control groups; this difference was not statistically significant. Other functional outcomes reported included need for bed rest [45], which was 8.0±0% in the experimental group and 10.0±1.4% in control groups after 1 year; reduced activity because of LBP [45], which was 33±0% in the experimental group and 36±1% in control groups after 1 year; marked or moderate improvement in a functional scale of 10 activities of daily living [48], which was 29% in the experimental group and 30% in the control group after 2 weeks.
Global effect
The global effect results can be found in Table 6. Five RCTs reported global effect using a variety of scales (eg, global impression of severity; global rating of care; composite score combining pain, stiffness, and tenderness) [29, 31, 45, 48, 52]. Results for global effect were statistically significant in favor of the experimental groups in two of five RCTs after 1 to 2 weeks [29, 31, 45, 48], in two of three RCTs after 3 to 4 weeks [29, 45, 52], and one of two RCTs after 2 to 3 months [29, 52]; no differences were noted beyond 6 months of follow-up [52].
Health-care utilization
The health-care utilization results can be found in Table 7. Six RCTs reported on health-care utilization for LBP, including analgesic medication use [28, 3133, 51] and other health-care use [28, 45]. For analgesic medication use, there were no statistically significant differences between groups after 2 weeks in three RCTs [31, 33, 51] nor after 2 months in one RCT [32]. Results after 6 months favored the experimental group in one RCT [28], though no differences were noted in another RCT after 1 year [32]. For other health-care use, results favored the experimental group after 6 months in one RCT [28]; no differences were noted in one RCT after 1 year [45].
Other outcomes
In addition to pain, function, global effect, and healthcare utilization, other outcomes were also measured and reported in these RCTs, and their results can be found in Table 8. These outcomes included lumbosacral range of motion (eg, degrees of flexion, extension, and rotation, or fingertip-to-floor distance) [26, 46, 48]; mental health (eg, SF-36 mental composite score, modified Zung Questionnaire) [31,32]; lost work time because of LBP [28, 32, 45]; and utility (eg, EuroQol-5D) [32]. Results for lumbosacral range of motion were not statistically significant between groups after 1, 2, 3 weeks, or 3 months [26, 46, 48]. Results for mental health were no different between groups after 2, 4 weeks or 2 or 6 months [3133] but were statistically significant in favor of the control group after 1 year [32]. Results for work loss because of LBP were statistically significant in favor of the experimental group after 6 months [28], though no differences were noted between groups after 1 year [32, 45]. Results for utility were not statistically significant between groups after 2 or 6 months or 1 year [32].
Subgroups
One RCT reported pain outcomes separately for subgroups that had either a positive or a negative straight leg raise (SLR) [51]. Results suggest that a greater proportion had recovered after 2 weeks in those with a positive SLR, though there were no apparent differences after 1 year [51]. Two RCTs reported functional outcomes separately for subgroups that had LBP for less than 2 weeks and for 2 to 4 weeks [49, 50]. Results suggest that a greater improvement in RMDQ was noted in those with LBP of 2 to 4 weeks duration after 3 days [49]; no further improvements were observed in this subgroup after 12 days, whereas those with LBP duration of less than 2 weeks noted additional improvement [49, 50]. One RCT reported global effect outcomes separately for subgroups with or without leg pain [52]. Results suggest that the experimental group was more superior to the control groups in those with leg pain after 3 weeks but not after 2 or 6 months [52].
Summary
Overall results for pain and functional outcomes are summarized in Tables 9 and 10, respectively.
Harms
Data on harms are presented in Table 11. None of the included studies reported harms specifically related to SMT.
Discussion
Improvements in pain and function
Spinal manipulation therapy appears to be effective for pain reduction in the short, intermediate, and long term. Only 1 to 2 weeks after initiating care with SMT, pain reduction was substantial (62%), though it was almost as large for the control groups against which it was compared. Pain reduction tended to peak within 3 to 4 weeks of beginning SMT (80%) and tapered slightly after 2 to 3 months (67%) and 6 months (65% SMT) but remained higher than that achieved after 1 to 2 weeks. Pain reduction continued to taper after 1 year (51%) and 2 years (66%). One-third of the studies that reported pain outcomes demonstrated a greater pain reduction for SMT than that for the control groups at one or more time points [31, 33, 45], whereas two-thirds showed no difference between SMTand control groups [26, 29, 32, 46, 47, 51]. No studies reported that SMT was inferior to other treatments in providing pain reduction at any time point. Of the studies that reported function and disability outcomes, most (seven out of nine) reported no difference compared with various control interventions [26, 31, 33, 45, 4850]. One study demonstrated a greater improvement for SMT at two time points [28], and one study demonstrated a greater improvement in control compared with SMT at one time point [32].
Relative efficacy
Results from most studies indicate thatSMTwas either superior or equivalent to many commonly used interventions, including physical modalities, education, exercise, and medication. In cases where SMT was equivalent to the control group, both groups improved. Lack of superiority for any particular approach is likely related to many conservative interventions having equally favorable results in the initial stages of LBP. This suggests that a patient with acute LBP (or a spine clinician involved in their care) can reasonably choose the most appealing of these management options based on availability, personal preference, expectation of improvement, or other factors beyond simply efficacy.
Treatment of acute low back pain
This review is unable to address a different research question that may also be of interest, that is, is any intervention at all necessary for acute LBP? The prognosis of acute LBP is generally viewed as favorable, with or without treatment. One could, therefore, suggest that the efficacy of SMT relative to other commonly used interventions is less important than that compared with no treatment at all. However, this question can only be addressed by RCTs in which SMT is compared with a pure no-treatment control group, which did not occur in the 14 RCTs included.
No-treatment control group
Although conducting an RCT of SMT compared with a no-treatment control group for acute LBP could be of scientific or economic interest, it may pose certain challenges. For example, it may be difficult to justify randomizing participants to a no-treatment control group when several commonly used interventions, including SMT, appear to be relatively safe, effective, inexpensive, and widely available. Even if an ethics review board approved such a study design, it may be challenging to recruit participants. At minimum, brief education of participants may be required as to why a no-treatment approach is appropriate, in effect, changing the no-treatment control group into a briefeducation control group. Once recruited, monitoring and compliance of participants assigned to a no-treatment control group could also be problematic as they may resort to self-prescribed nonstudy interventions (eg, over-thecounter analgesics) for pain relief. This issue may warrant further discussion among clinicians, researchers, and ethicists, but cannot be addressed from this review of currently available RCTs.
Previous systematic reviews on this topic
The present review uncovered five new RCTs [28, 29, 3133] that were conducted after publication of two previous SRs on the same topic [23, 53]. The present review focused exclusively on acute LBP, whereas the two previous reviews included acute, subacute, and chronic LBP. Nevertheless, our results appear to be generally consistent with those of the two previous SRs. It is important to note, however, that interpretation of the results and conclusions drawn from them are different among the SRs. For example, the present review concludes that SMT is equally effective as other commonly used conservative approaches for acute LBP. On the other hand, a previous SR interpreted similar evidence and concluded that SMT had no statistically or clinically significant advantage over general medical care, analgesic medication, physical therapy, exercises, or back school [23]. Although both conclusions are similar, their wording may influence how their findings will be perceived by those who do not read the full study report.
Systematic versus narrative reviews
There are many different ways to approach a review article. A narrative review simply proposes one or more hypotheses and cites studies supporting those points. On the other hand, an SR approaches the process in an organized and transparent manner that removes much of the bias that can be introduced in a narrative review. When conducted appropriately, SRs are considered to be an important tool in evidence-based medicine. The main steps required in an SR are to define a research question; devise a comprehensive and transparent search strategy to uncover relevant studies; specify study eligibility criteria; screen results independently by two reviewers to avoid bias in selecting studies; evaluate methodological quality; summarize results for similar studies; and interpret findings for those who do not have the time, expertise, or willingness to do so. Embedded within each of these steps are decisions that authors must make that can impact their findings. Readers should be aware of these potential limitations.
Duplicate reports
Numerous duplicate reports were uncovered in the search. Many of these reports were related to the same cohort of participants but reported new analyses that attempted to explain observed differences by examining various hypotheses, including gender [36], confidence [37], satisfaction [40], and lumbar mobility [35]. Although secondary analyses can provide greater insight when interpreting results, duplicate reports can also artificially inflate the amount of evidence supporting an intervention if readers are not aware whether they are referring to the same patient population [5456].
Eligibility criteria
Many of the RCTs appear to have been designed pragmatically rather than using standardized methodology. For example, acute LBP is a fairly simple, universal concept typically defined as duration of symptoms of less than 12 weeks [7]. However, many RCTs have defined acute LBP in differing ways that preclude combining their results in SRs or meta-analyses. When designing future RCTs, investigators should consider how data from their study might be combined with data from other studies.
Providers
It has been estimated that 94% of SMT is administered by DCs [57]. However, only 38% (5 out of 13) of the studies which reported provider type involved DCs as providers of SMT. Potential explanations for this observation include insufficient funding of RCTs outside medical research universities, inadequate research training or infrastructure for DCs to conduct RCTs, or a perception that efficacy of SMT for acute LBP has been sufficiently answered and is no longer of primary research interest. The involvement of PTs as authors or providers of SMT was greater than that one might expect, as they were involved in 38% (5 out of 13) of the studies, including three of the most recent RCTs [28, 29, 32]. It is unknown if results from SMT administered by different providers are interchangeable in terms of efficacy. Nonetheless, it is interesting to note that SMT was administered by DCs in all of the studies that reported greater pain reduction in the SMT group over control groups at one or more time points [31, 33, 45].
Frequency and duration of spinal manipulation therapy
For acute LBP, it is common practice to recommend two to three sessions per week for the first few weeks and then to gradually decrease the frequency of treatments during subsequent weeks. In the reviewed studies, the total number of SMT sessions ranged from 1 [47, 49] to 20 sessions over 30 days [33]. Data on SMT frequency and duration were ambiguous in some of the reviewed studies; hence, the extent to which these variables affected outcomes is uncertain. However, there is no evidence to suggest that 20 treatment sessions offer clear advantages over 5 to 10 treatment sessions.
Cointerventions
Cointerventions, including passive physical modalities, massage, assisted stretching, exercises, and medications, were often administered concurrently with SMT. Investigators who design RCTs that use multiple cointerventions likely do so to reflect how SMT is used in clinical practice. However, this practice draws on anecdotal evidence and other factors as patients attempt to find symptomatic relief. Administering numerous interventions in RCTs without appropriate control groups (eg, placebo) obscures the unique contribution of specific therapies, including those of interest to investigators (ie, SMT). It may even increase the possibility that no difference will be found among the various treatments. The end result is that such studies are typically not useful in the clinical decision-making process. Monitoring the use of cointerventions would likely require a participant diary that could be verified through claim records. This item is challenging to assess when the control group intervention is a cointervention in the experimental group (eg, analgesics). In such cases, control group use should not be comparable among study arms. Studies with protocols requiring multiple sessions should report compliance to help determine if it affects outcome. This would also allow subgroup analyses of dose and frequency effects.
Spinal manipulation therapy techniques
Many different SMT techniques are used for LBP by a variety of providers. However, most of the studies we reviewed did not include sufficient details of the technique used. One study did directly compare two common techniques (HVLA SMT and rotational MOB), but only one treatment session of SMT was carried out in this study [49]. Therefore, we were not able to draw conclusions about the relative efficacy of different SMT techniques.
Methodological quality
We found that most of the new CBRG criteria were useful in assessing methodological quality. However, it was difficult to evaluate the new CBRG criterion regarding selective outcome reporting, which was assumed to be absent unless outcomes were specified in the objectives but not reported. Presumably, the authors intent on concealing unfavorable results would not mention those outcomes at all rather than selectively mention in portions of the manuscript that could create doubts among readers. Furthermore, the relevance of blinding for physical interventions, such asSMT, is questionable. Providers cannot readily be blinded to a skilled manual technique they deliver. Participants cannot easily be blinded unless a sham SMT is devised, which may itself have therapeutic effect. When the primary outcomes are selfreported, blinding the outcome assessor is also less relevant. Nevertheless, these CBRG criteria are widely used.
Funding
The source of funding is an important methodological consideration because of the potential for funding bias [58,59]. The source of funding for the included studies is presented in Table 12. All of the included studies reported a funding source, which was either a not-for-profit agency (n = 11) or a government organization (n = 5). Three of the included studies also reported an in-kind donation or the use of equipment for theRCTfrom private industry, indicating that the results of this review are likely not influenced by funding bias.
Harms
Spinal manipulation therapy appears to be relatively safe, as no harms were attributed to SMT in the five studies that reported harms data. Because RCTs are typically not powered to estimate the risk of harms, the literature on this topic was also briefly reviewed to provide additional information about the known or potential harms of SMT. After reviewing this literature, it appears that harms associated with SMT can be divided into relatively common, minor, temporary, and self-limiting harms (eg, side effects), or very rare, more serious adverse events (SAEs).Minor, temporary, and self-limiting harms The minor, temporary, and self-limiting harms that have been reported after lumbar SMT include local discomfort, stiffness, radiating pain, and fatigue; these symptoms are typically reported to last between several hours and a few days [8,60]. These minor, temporary, and self-limiting harms have been reported by 30% to 50% of those receiving lumbar SMT and have also been reported more frequently in females [61].
Very rare serious adverse events In contrast, very rare SAEs have only been reported in the literature through case reports or case series. The main types of SAEs associated with lumbar SMT are lumbar disc injury, cauda equina syndrome, spinal cord ischemia or infarct, vertebral fracture, and epidural hematoma [6270]. These very rare SAEs are reported so infrequently that few risk factors have yet been identified, though anti-coagulation therapy may be associated with epidural hematoma. In addition, the frequency of very rare SAEs is difficult to estimate with any precision, as this requires estimating both a very small numerator (ie, reported SAEs) and a very large denominator (ie, total number of lumbar SMT in a given period). One review reported that the rate of disc herniation or cauda equina syndrome after lumbar SMT was 1 per 3.7 million procedures; the confidence interval around this estimate is unknown but likely to be wide [71].
Conclusion
Based on the RCTs reviewed, SMT appears to be effective for pain reduction in the short, intermediate, and long terms. One-third of the studies included in this SR demonstrated more pain reduction with SMT than for control groups at one or more time points, whereas two-thirds showed no difference between SMT and the control groups. No study found SMT to be inferior to other treatments in regard to pain reduction at any time. There is no evidence to suggest that a higher number of treatment sessions with SMT was superior to the commonly used 5 to 10 treatment sessions. With the currently available evidence, the choice of SMT versus other treatment approaches for acute LBP cannot be made on the basis of relative efficacy alone. That decision must, therefore, be based on patient preference, treatment availability, treatment cost, or other factors.
Acknowledgments
The authors would like to thank all members of the NASS Complementary Medicine Task force for their advice and work on this project (in alphabetical order): Thiru M. Annaswamy, MD; Jay E. Bowen, DO; Simon Dagenais, DC, PhD; Michael D. Freeman, PhD, DC, MPH; Mark R. Foster, MD, PhD; Kim J. Garges, MD, DC; Ralph E. Gay, MD, DC; John M. Mayer, PhD, DC; Steven A. Schopler, MD. The authors would also like to thank their NASS staff liaison, Karen James, for her efforts on this project.
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