Level of evidence ratings were assigned to each included article independently by two reviewers using criteria set by The Journal of Bone and Joint Surgery, American Volume (J Bone Joint Surg Am)21 for therapeutic studies and modified to delineate criteria associated with methodologic quality and described elsewhere.22
We performed all analyses on a study level. For pain visual analogue scales, we standardized all scales on a 0- to 10-point scale. We calculated the change scores and the corresponding standard deviations from pre- and postoperative pain and function scores reported by the authors. Study level data were pooled across studies if the treatment comparisons and outcomes were the same or similar and if sufficient data were provided to calculate effect sizes. The standardized mean differences (SMDs) comparing the overall treatment effects were calculated by subtracting the mean change scores and dividing by the change score standard deviations. The reporting of effect estimates facilitates the interpretation of the size of the effect of a specific treatment as opposed to the statistical significance. Both fixed-effect and random-effect estimates were performed for pooled data. Fixed-effects methods are based on the assumption that a single common effect underlies each study being pooled with no significant heterogeneity among the studies. Random-effects methods are based on the assumption that individual studies are estimating different treatment effects, reflective of heterogeneity. That is, random-effects methods allow that the true effect could vary from study to study which accounts for both within- and between-study error.
Overall Strength of Body of Literature
The initial strength of the overall body of evidence was considered high if the majority of the studies were level 1 or 2 and low if the majority of the studies were level 3 or 4. We downgraded the body of evidence one or two levels based on the following criteria: (1) inconsistency of results, (2) indirectness of evidence, or (3) imprecision of the effect estimates (e.g., wide confidence intervals). We upgraded the body of evidence one or two levels based on the following criteria: (1) large magnitude of effect or (2) dose-response gradient. The overall strength of the body of the literature was expressed in terms of our confidence in the estimate of effect and the impact that further research may have on the results. An overall strength of “high” means we have high confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect. The overall strength of “moderate” means that we have moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate. A grade of “low” means we have low confidence that the evidence reflects the true effect. Further research is likely to change the confidence in the estimate of effect and likely to change the estimate. Finally, a grade of “insufficient” means that evidence either is unavailable or does not permit a conclusion. A more detailed description of this process can be found in the “Materials and Methods” section.22
Manipulation Versus Exercise
For question 1 (manipulation vs. exercise), our systematic search identified 18 potential studies and 2 systematic reviews (Figure 1). We identified two additional studies published since the most recent review.2 Among the 18 potential studies, we selected 7 for full-text review.23–29 Among these, five were excluded for the following reasons: subjective selection criteria (tenderness over facet joints required),27 lack of a clearly defined spinal manipulation group,25 treatment intervention not randomized,26 no structured exercise group and inclusion of patients with less than 3 months of LBP,28 and lack of a clean exercise versus manipulation comparison.23 Consequently, this question included two studies: one identified in the review by van Middelkoop et al2 (Ferreira et al24) and the other published since that review (Cecchi et al.29). Details of study characteristics and patient populations are in the supplementary digital material (see supplementary tables, Supplemental Digital Content 1, http://links.lww.com/BRS/A540 and Supplemental Digital Content 2, http://links.lww.com/BRS/A541).
In the first included article, Ferreira et al24 conducted an RCT of 240 adults with chronic LBP comparing SMT (defined as joint mobilization or manipulation applied to the spine or pelvis by a physical therapist), general exercises performed under supervision, and motor control exercises (focused on specific trunk muscles thought to control intersegmental motion in the lumbar spine).24 Treatment was performed over an 8-week period with initial follow-up at 8 weeks and final follow-up at 12 months. Study outcomes were the patient-specific functional scale, the global-perceived effect scale, pain (visual analog scale), Roland-Morris Disability Questionnaire score, and global-perceived effect scale. We summarized the visual analog scales and the Roland-Morris Disability Questionnaire scores as the other study in our review also reported these measures. Clinical improvement was noted in all groups at 8 weeks. At 12 months, there was no significant difference when comparing the motor control exercise group and the SMT group with respect to changes in pain (SMD = −0.26; 95% confidence interval [CI]: −0.57 to 0.51;) Table 2 and Figure 3). With respect to changes in function, the motor control exercise group was favored (SMD = −2.07; 95% CI: −2.46 to −1.69) (Table 2 and Figure 4). Similar findings were observed with general exercise compared with SMT, although the relative change in function was less than that noted for the motor control exercise group (Table 2). The authors reported no significant difference between groups with respect to the patient-specific functional scale and global-perceived effect scale.
In the second included study, Cecchi et al29 conducted an RCT of patients with chronic LBP assigned to receive a 3-week intervention of either back school (including “individual tailored” exercises) or mixed physiotherapy or a 4- to 6-week SMT intervention (performed via a “manual medicine approach” by physical medicine and rehabilitation specialists with approximately 10 years of experience).29 Follow-up was for 12 months; the primary study outcomes were the Roland-Morris Disability Questionnaire score and secondary outcomes were pain, pain recurrence, further back pain treatment, and sick leave. Although change in pain (SMD = 5.32; 95% CI: 4.61–6.04) and function (SMD = 2.32; 95% CI: 1.89–2.76) favored the SMT group (Table 2 and Figures 3 and 4), further treatment for LBP during the follow-up period was significantly more frequent in the SMT group. Approximately 50% of this group received further SMT, and the exercise program provided in the “back school” was limited in scope and delivered only over the final 2 weeks of the program. In addition, a greater proportion of patients in the “back school” group were on sick leave due to their back pain at study inception.
The pooled analysis used the motor control exercise group instead of the general exercise group from the Ferreira et al study24 since the effects were larger. We chose not to pool the two exercise groups from this study as they were distinct from one another. Any effect added by the general exercise group would move the difference closer to the null. When the two studies were pooled, spinal manipulation was favored slightly over motor control exercise (SMD = 0.632; 95% CI: 0.347–0.917) with respect to pain when using a fixed-effect model and no significant difference was observed when using a random-effects model (SMD = 2.52; 95% CI: −2.95–8.0) (Table 2 and Figure 3). We are relying on the random-effects model for our conclusions due to the substantial differences between both the SMT and exercise interventions in the two studies and the significant heterogeneity in the treatment effects. Neither intervention was favored with both the fixed- and random-effects models with respect to function (Table 2, Figure 4).
Acupuncture Versus Exercise
For question 2 (acupuncture vs. exercise), our initial search yielded 12 potential articles, 10 of which were excluded on the basis of our criteria (five did not include adequate exercise comparison group; three were not RCTs; two assessed pregnancy-related LBP). Two articles were selected for full-text review; however, neither was selected for inclusion in our review13,30 (Figure 1). The study by Haake et al13 included 1162 patients and compared verum acupuncture, sham acupuncture, and “conventional care.” This article was excluded because the comparison group received a combination of drugs, physical therapy, and exercise. Interestingly, this study found that the “true” and “sham” acupuncture groups had equivalent degrees of improvement compared with the “conventional care” group. A smaller study of 52 patients by Yeung et al30 comparing exercise alone to exercise with electro-acupuncture was excluded, because acupuncture was delivered as part of a combined treatment approach.
Acupuncture Versus Manipulation
For question 3 (acupuncture vs. manipulation), our initial search yielded 17 potential articles, 14 of which were excluded because they were not RCTs. Three were selected for full-text review; one was excluded because it did not include interventions of interest.31 The remaining two articles were based on the same RCT32,33 and were excluded because patients had spine problems affecting the cervical, thoracic, and/or lumbar regions, not isolated chronic LBP, and the data were not presented in a manner that allowed for isolation of the patients with only LBP (Figure 1).
Subgroups and Cost-Effectiveness
For question 4 (subgroups), we examined the studies included for questions 1, 2, and 3 (total = two studies). Neither study included subgroup analyses. For question 5, cost-effectiveness studies evaluating treatment of chronic LBP, our initial search yielded 79 citations. Ten were selected for full-text review. All 10 articles were subsequently excluded from our review: two were review or methods articles19,34; two did not meet our inclusion criteria for economic evaluations35,36; two did not meet our patient-group criteria37,38; and four did not meet our intervention criteria (Figure 2).34,39–41
The overall strength of the evidence evaluating the comparative effectiveness of the structured exercise versus SMT was “low.” That is, we have low confidence that the evidence reflects the true effect and further research is likely to change the confidence in the estimate of effect and likely to change the estimate (Table 3). The overall strength of the evidence evaluating the comparative effectiveness of the structured exercise versus acupuncture, SMT versus acupuncture, comparative subgroup effects, and cost-effectiveness comparing the aforementioned treatments was “insufficient.” That is, evidence is either unavailable or does not permit a conclusion.
Despite the high prevalence of LBP and the substantial societal and individual costs associated with it, there is very little clinical evidence from which to base comparative decisions for nonoperative therapeutic options for a given patient. There are studies that support the benefit of many distinct approaches to chronic LBP, although there are also many studies that identify significant limitations for most treatments. There may well be substantial benefit to simply intervening in the pain state of individuals with chronic LBP, and the benefit associated with many treatments may be related to nonspecific effects. When considered as a whole, the evidence regarding the superiority of one treatment above others for specific patients is lacking. The problem is not necessarily that all nonoperative approaches lack efficacy, but, rather, the problem may lie in the complexity of LBP and in the methodologic shortcomings of existing clinical studies.
Given the psychosocial complexities often associated with chronic pain, treatment approaches that address the psychologic functioning or fundamental belief systems of the patient regarding injury and recovery may be an important component of care for those who fail to respond to initial measures or who clearly have difficulties in this regard. Although multimodal approaches did not fall within the scope of this review, cognitive behavioral therapy may be a beneficial component of care for many patients when delivered in conjunction with more active treatments.42,43 Cognitive behavioral therapy is not necessarily a uniform therapeutic approach and can be delivered in many settings but generally has the primary goal of replacing maladaptive coping skills, beliefs, and behaviors with more appropriate systems. It is often a component of multidisciplinary pain programs and can also accompany structured exercise or physical therapy programs.42,44
Overall, either comprehensive registries allowing for subject stratification or comparative clinical studies with rigorous design, identification of valid and identifiable subgroups and treatment arms with clearly defined interventions are a very high priority if we are to use nonoperative measures in the most efficacious and cost-effective manner.
EXERCISE VERSUS SPINAL MANIPULATIVE THERAPY
Exercise as a specific therapeutic intervention to treat LBP clearly could entail a broad range of approaches, and it may well be the case that different exercise programs are more appropriate for certain individuals. However, the current literature is not supportive of one particular exercise approach being superior to others in the treatment of chronic LBP. There may well be generalized effects from any type of structured exercise that infer benefits for those with chronic LBP.2,3,45 Numerous RCTs have demonstrated the overall benefit of exercise to general health and a number of authors have noted the importance of overall fitness in LBP care and prevention.46–49
Similarly, many studies of SMT use variable approaches that are termed “manipulation,” often delivered with cointerventions or within the framework of a specific method of practice. In a more defined sense, SMT is a highly specific maneuver that requires considerable training and experience. A number of published studies indicate that SMT has some effectiveness in the treatment of acute and chronic back pain with respect to pain and return to function.50 Clear delineation of the relative benefits of SMT and exercise would be beneficial for clinicians and patients.
We identified two studies meeting our inclusion criteria that compared the structured exercise with the SMT in the treatment of chronic LBP. Although the exercise and SMT interventions differed substantially between the studies, both treatment groups showed improvements in pain and function in both studies, indicating some potential benefit of each approach. However, the data provided by these studies are insufficient to establish if one of these treatments is superior to the other in the treatment of chronic LBP. As the clinical benefits of these approaches were evident within 8 weeks in the studies identified, it would seem reasonable to expect some degree of clinical improvement within this time frame for a given treatment. If there is no apparent benefit within 8 weeks, then the care plan should be reevaluated and consideration should be given to modifying the specific treatment approach or to utilizing alternate forms of care.
ACUPUNCTURE VERSUS MANIPULATION OR EXERCISE
Although there is some evidence that acupuncture may potentially offer benefit for those with LBP,11 we did not identify any RCTs fulfilling our inclusion criteria that compared acupuncture with the manipulation or structured exercise in the treatment of chronic LBP. In the course of our literature review, we did encounter two RCTs comparing acupuncture to sham or the simulated acupuncture with “usual back care”13,51 that have been published since the date of the literature review by Furlan et al.11 Both of these studies observed significant but equivalent benefit for acupuncture and sham or simulated acupuncture over “usual care” in the treatment of LBP. The lack of observed differences between acupuncture and simulated or sham acupuncture raises significant questions regarding the mechanism of action of this treatment, including the possibility of a dominant role of placebo response or other nonspecific effects. Additional high-quality comparative trials are needed to define the role of acupuncture in the treatment of chronic LBP, and these should likely include a sham or simulated treatment arm.
As the number of comparative studies meeting our inclusion criteria was small, there were insufficient data from which to identify any subgroup that benefited from any specific treatment. This finding speaks to the substantial limitations of the medical literature in this regard. It may also speak to substantial problems in our medical classification of patients with chronic LBP. It is clear that the broad categorization of patients as having “chronic LBP” lacks the granularity needed for the researchers and the clinicians to be able to adequately study specific therapies. Further work on establishing clinically relevant, reliable methods of subgrouping individuals with chronic LBP is critically necessary. Appropriately structured registries may be one means of acquiring data that allows for the identification of valid clinical subgroups.
Unfortunately, there are very few published studies on the cost-effectiveness of treatments for LBP in general. The recent systematic reviews on this topic19,20 included studies on a wide variety of treatment modalities and came to conflicting conclusions despite largely relying on the same limited literature base. There is also controversy about the minimum effectiveness threshold (or alternatively, the maximum cost per quality adjusted life year gained) that is acceptable for the treatment of pain. This threshold could differ substantially depending on the severity and chronicity of symptoms, prevalence of disease, and societal views about rationing care.52,53
We were unable to identify any studies of cost-effectiveness comparing exercise, SMT, or acupuncture that met our inclusion criteria. Although not specifically addressing chronic LBP, the UK back pain exercise and manipulation trial38 was an interesting four-arm RCT that compared “best care” (i.e., a standard of care providing education) with “best care” with structured group exercise, SMT, or SMT with group exercise. This study found that SMT, SMT with exercise, and “best care” could all potentially be considered cost-effective treatments for LBP depending on the maximum cost per quality adjusted life year threshold chosen (>£8700, between £8700 and £3800, or <£3800, respectively). The exercise-alone group demonstrated the clinical improvements as compared with “best care”, but to a lesser degree than the SMT groups and at a higher cost than the SMT with the exercise group. These higher costs for the exercise group were in large part due to the costs of additional physical therapy sessions as well as medical care that this group received. This study highlights the importance of defining cost-effectiveness thresholds to interpret comparative cost data. Clearly, there is a great need for additional cost-effectiveness studies of structured exercise, acupuncture, and SMT for chronic LBP.
Exercise therapy, SMT, and acupuncture may all have a role in the clinical management of patients with the chronic LBP. The overall evidence of benefit for any of these is not profound however, and we were unable to identify any evidence of comparative benefit of one of these over the others. Given the limitations of the literature, we are also unable to determine if they are truly equivalent, either. Acupuncture, in particular, is poorly addressed in the current literature, and evidence of equivalency between acupuncture and sham or simulated acupuncture in the treatment of LBP has implications regarding the use and mechanism of action of this treatment as well as for future study.
Further data are clearly necessary, and the establishment of the broad registries and the performance of high-quality studies on the comparative effectiveness of exercise, SMT, and acupuncture in the treatment of chronic LBP would appear to be priorities for clinicians, payers, and patients. Ideally, further clinical studies should include well-defined treatment arms, an identifiable and clinically relevant study population, appropriately trained providers, and enough subjects to allow for subgroup analyses and power to detect real differences. For exercise, a structured, active treatment program without cointerventions should be considered. SMT should consist of a clearly defined method of manipulation performed by the appropriately trained and the experienced providers. Given the literature discussed above on acupuncture, treatment arms of established evaluation and treatment methods as well as sham or simulated acupuncture should be included. Either identifying valid subgroups a priori or obtaining thorough baseline demographics and diagnostic/clinical information in a large study group to allow post hoc analysis will be essential for identification of differential benefits for subpopulations. Cost data and long-term outcomes should be included in such studies to reliably assess clinical outcomes and cost-effectiveness over time.
- Structured exercise and SMT appear to offer equivalent benefits in the treatment of chronic LBP, although the level of evidence in this regard is low.
- If there is no clinical improvement perceived within 8 weeks of initiating SMT or a particular exercise treatment, then the care plan should be reevaluated.
- There is insufficient evidence in the medical literature to determine the relative effectiveness of the acupuncture compared with either exercise or SMT in the treatment of chronic LBP.
- There is insufficient evidence in the medical literature to determine the relative cost-effectiveness of exercise, SMT, and acupuncture in the treatment of chronic LBP.
- Comprehensive registries and comparative clinical studies with rigorous design, identification of valid and identifiable subgroups, and treatment arms with clearly defined interventions are necessary if we are to optimize the clinical and cost-effectiveness of nonoperative care for the chronic LBP.
Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.spinejournal.com).
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acupuncture; chiropractic; comparative effectiveness; cost-effectiveness; exercise; low back pain; spinal manipulative therapy; systematic review
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