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AIME - Nonpharmacologic Therapies For Low Back Pain PDF
AIME - Nonpharmacologic Therapies For Low Back Pain PDF
Background: A 2007 American College of Physicians guideline ings regarding the effectiveness of yoga (SOE, moderate).
addressed nonpharmacologic treatment options for low back Evidence continues to support the effectiveness of exercise, psy-
pain. New evidence is now available. chological therapies, multidisciplinary rehabilitation, spinal ma-
nipulation, massage, and acupuncture for chronic low back pain
Purpose: To systematically review the current evidence on non- (SOE, low to moderate). Limited evidence shows that acupunc-
pharmacologic therapies for acute or chronic nonradicular or ra- ture is modestly effective for acute low back pain (SOE, low). The
dicular low back pain. magnitude of pain benefits was small to moderate and generally
Data Sources: Ovid MEDLINE (January 2008 through February short term; effects on function generally were smaller than ef-
2016), Cochrane Central Register of Controlled Trials, Cochrane fects on pain.
Database of Systematic Reviews, and reference lists. Limitation: Qualitatively synthesized new trials with prior meta-
Study Selection: Randomized trials of 9 nonpharmacologic op- analyses, restricted to English-language studies; heterogeneity
tions versus sham treatment, wait list, or usual care, or of 1 non- in treatment techniques; and inability to exclude placebo effects.
pharmacologic option versus another. Conclusion: Several nonpharmacologic therapies for primarily
Data Extraction: One investigator abstracted data, and a sec- chronic low back pain are associated with small to moderate,
ond checked abstractions for accuracy; 2 investigators indepen- usually short-term effects on pain; findings include new evidence
dently assessed study quality. on mind– body interventions.
Data Synthesis: The number of trials evaluating nonpharmaco- Primary Funding Source: Agency for Healthcare Research and
logic therapies ranged from 2 (tai chi) to 121 (exercise). New Quality. (PROSPERO: CRD42014014735)
evidence indicates that tai chi (strength of evidence [SOE], low) Ann Intern Med. 2017;166:xxx-xxx. doi:10.7326/M16-2459 Annals.org
and mindfulness-based stress reduction (SOE, moderate) are ef- For author affiliations, see end of text.
fective for chronic low back pain and strengthens previous find- This article was published at Annals.org on 14 February 2017.
Function
5–10 points on the ODI >10–20 points on the ODI >20 points on the ODI
1–2 points on the RDQ >2–5 points on the RDQ >5 points on the RDQ
Pain or function
0.2–0.5 SMD >0.5–0.8 SMD >0.8 SMD
ODI = Oswestry Disability Index; RDQ = Roland Morris Disability Questionnaire; SMD = standardized mean difference; VAS = visual analogue scale.
atic Reviews (through April 2015). We used the previ- tematic review, we abstracted details regarding the
ous ACP/APS review to identify earlier studies (8). study, population, and treatment characteristics, as well
Searches were updated through November 2016. as the results (Supplement Table 2, available at Annals
We also reviewed reference lists and searched .org).
ClinicalTrials.gov. Two investigators independently assessed the
Study Selection quality of each study as good, fair, or poor by using
criteria developed by the U.S. Preventive Services Task
Two investigators independently reviewed ab-
Force (11) (for randomized trials [Supplement Table 3,
stracts and full-text articles against prespecified
available at Annals.org]) and AMSTAR (A Measurement
eligibility criteria. The population was adults with acute
Tool to Assess Systematic Reviews; for systematic re-
(<4 weeks), subacute (4 to 12 weeks), or chronic (≥12
views [Supplement Table 4, available at Annals.org])
weeks) nonradicular or radicular low back pain. Ex-
(9).
cluded conditions were low back pain due to cancer,
For primary studies included in systematic reviews,
infection, inflammatory arthropathy, high-velocity
we relied on the quality ratings as performed in the
trauma, or fracture; low back pain during pregnancy;
reviews. We used the overall grade (for example, good,
and the presence of severe or progressive neurologic
fair, or poor; or high or low) as determined in the sys-
deficits. We included randomized trials of exercise,
tematic review.
spinal manipulation, acupuncture, massage, mind–
We classified the magnitude of effects for pain and
body interventions (yoga, tai chi, mindfulness-based
function by using the same system used in the ACP/
stress reduction), psychological therapies, or multidis-
APS review (Table 1) (2, 12). We also reported risk es-
ciplinary rehabilitation versus sham (functionally inert)
timates based on the proportion of patients achieving
treatment, wait list, or usual care (usually defined as
successful pain or function outcomes (such as >30% or
care provided at the discretion of the clinician), as well
>50% improvement).
as comparisons between 1 therapy and another. Out-
comes were long-term (≥1 year) or short-term (≤6 Data Synthesis and Analysis
months) pain, function, return to work, and harms.
We synthesized data qualitatively for each interven-
Given the large number of interventions, we in-
tion, stratified according to the duration of symptoms
cluded systematic reviews of randomized trials (6, 9).
(acute, subacute, or chronic) and presence or absence
For each intervention, we selected the most recent, rel-
of radicular symptoms. We reported meta-analysis re-
evant, and comprehensive systematic review that was
sults from systematic reviews. If statistical heterogeneity
of the highest quality on the basis of a validated assess-
was present, we examined the degree of inconsistency
ment tool (9, 10). If more than 1 good-quality system-
and evaluated subgroup and sensitivity analyses. We
atic review was available, we preferentially selected up-
did not conduct an updated meta-analysis; rather, we
dates of reviews used in the ACP/APS review. We
qualitatively examined whether the results of new stud-
supplemented systematic reviews with additional ran-
ies were consistent with pooled or qualitative findings
domized trials. We did not include systematic reviews
from previous systematic reviews. Qualitative assess-
identified in update searches but checked reference
ments were based on whether the findings from the
lists for additional studies. We excluded non–English-
new studies were in the same direction as those of the
language articles and abstract-only publications.
previous systematic reviews and whether the magni-
Data Extraction and Quality Assessment tude of effects was similar; if previous meta-analyses
One investigator extracted study data, and a sec- were available, we assessed whether the estimates and
ond verified the accuracy of the extractions. For system- CIs from the new studies were encompassed in the
atic reviews, we abstracted details about review meth- CIs of previous pooled estimates. We assessed the
ods and results (Supplement Table 1, available at strength of evidence (SOE) for each body of evidence
Annals.org). For randomized trials not included in a sys- as high, moderate, low, or insufficient on the basis of
2 Annals of Internal Medicine • Vol. 166 No. 7 • 4 April 2017 Annals.org
Excluded (n = 700)‡
Wrong population: 86
Wrong intervention: 186
Wrong outcomes: 47
Wrong study design for KQ: 92
Not a study (letter, editorial, nonsystematic review article):
80
Not English language, but possibly relevant: 45
Pre-2007 systematic review or superseded by a more
recent review: 66
Inadequate duration: 4
Sample size too small: 32
Individual studies included in systematic reviews for full
AHRQ report: 44
Wrong comparison (no control group): 15
Review used to identify individual studies: 3
ACP = American College of Physicians; AHRQ = Agency for Healthcare Research and Quality; APS = American Pain Society; KQ = key question;
RCT = randomized, controlled trial; SR = systematic review.
* Cochrane databases include the Cochrane Register of Controlled Trials and the Cochrane Database of Systematic Reviews.
† Other sources include prior reports, reference lists of relevant articles, systematic reviews, and others.
‡ Publications may be included or excluded for several interventions.
Table 2. Nonpharmacologic Treatments Versus Sham, No Treatment, or Usual Care for Chronic Low Back Pain
Table 3. Nonpharmacologic Treatments Versus Sham, No Treatment, or Usual Care for Acute Low Back Pain
multidisciplinary physical therapy. Multidisciplinary decreased pain intensity more than sham acupuncture
rehabilitation also was associated with less long-term immediately after the intervention (4 trials: WMD,
pain intensity and disability than usual care (7 trials: ⫺16.76 [CI, ⫺33.3 to ⫺0.19]) and through 12 weeks (3
SMD, ⫺0.21 [CI, ⫺0.37 to ⫺0.04], and 6 trials: SMD, trials: WMD, ⫺9.55 [CI, ⫺16.5 to ⫺2.58]), with no dif-
⫺0.23 [CI, ⫺0.40 to ⫺0.06], respectively) and nonmul- ferences in function. Five trials that could not be pooled
tidisciplinary physical therapy (9 trials: SMD, ⫺0.51 [CI, or were not included in the review reported results con-
⫺1.04 to 0.01], and 10 trials: SMD, ⫺0.68 [CI, ⫺1.19 to sistent with these findings (60, 66 – 69). The systematic
⫺0.16], respectively) and with greater likelihood of re- review found that compared with medications (non-
turn to work compared with nonmultidisciplinary reha- steroidal anti-inflammatory drugs, muscle relaxants, or
bilitation (8 trials: odds ratio, 1.87 [CI, 1.39 to 2.53]), analgesics), acupuncture resulted in greater pain relief
with no difference versus usual care (7 trials: odds ratio, (3 trials: WMD, ⫺10.56 on a 0- to 100-point scale [CI,
1.04 [CI, 0.73 to 1.47]). Two trials in patients with sub- ⫺20.34 to ⫺0.78]) and better function (3 trials: SMD,
acute low back pain reported findings consistent with ⫺0.36 [CI, ⫺0.67 to ⫺0.04]) immediately after the
those in patients with chronic symptoms (55, 56). intervention.
Acupuncture Massage
Acupuncture was evaluated in 49 trials. Of these Massage was evaluated in 26 trials, 13 of which (n =
studies, 11 (n = 1163; range, 40 to 300) were in a sys- 1596; range, 39 to 262) were included in a systematic
tematic review of acupuncture for acute or subacute review (70); we identified another 13 trials (n = 1633;
low back pain (58) and 32 (n = 5931; range, 16 to 2831) range, 15 to 579) (29, 71– 82). The systematic review
in a systematic review of acupuncture for chronic low classified 6 trials as low risk of bias, and we rated 3
back pain (59), and we identified 6 additional trials (n = additional trials (29, 71, 72) as good quality.
864; range, 80 to 275) (60 – 64). The systematic reviews For chronic low back pain, 1 trial found that struc-
categorized 22% and 45% of trials as low risk of bias; tural or relaxation massage had small effects on the
we rated 3 additional trials as good, 2 as fair, and 1 as RDQ (mean, 2.0 to 2.9 points) versus usual care at 10 to
poor quality. 12 weeks, with smaller effects at 52 weeks (71); how-
For acute low back pain, a systematic review found ever, another trial found no RDQ effects from massage
that acupuncture decreased pain intensity more than (Swedish massage, soft tissue release, and stretching)
sham acupuncture with nonpenetrating needles (2 tri- versus usual care (29). Three trials found no clear differ-
als: mean difference, 9.38 on a 0-to 100-point VAS [CI, ence in pain or function between foot reflexology and
1.76 to 17.0]) (58). Two other trials reported inconsis- usual care or sham (light foot) massage (79, 81, 83).
tent effects on pain intensity (61, 65). Acupuncture had Compared with several noninvasive interventions
no clear effects on function (5 trials) (58, 61, 62). Com- (manipulation, exercise, relaxation therapy, acupunc-
pared with nonsteroidal anti-inflammatory drugs, acu- ture, physiotherapy, transcutaneous electrical nerve
puncture was associated with a slightly greater likeli- stimulation), massage had better effects on short-term
hood of overall improvement at the end of treatment (5 pain in 8 of 9 trials (mean differences, ⫺0.6 to ⫺0.94
trials: relative risk, 1.11 [CI, 1.06 to 1.16]). points on a 0- to 10-point scale) and short-term function
For chronic low back pain, the systematic review in 4 of 5 trials (70, 82). Comparisons of various massage
found that acupuncture was associated with lower pain techniques were heterogeneous, and estimates were
intensity (4 trials: SMD, ⫺0.72 [CI, ⫺0.94 to – 0.49]) and imprecise (71–74, 80, 84, 85).
better function (3 trials: SMD, ⫺0.94 [CI, ⫺1.41 to
⫺0.47]) immediately after the intervention compared Spinal Manipulation
with no acupuncture (59). Mean effects on pain ranged Spinal manipulation was evaluated in 61 trials. Of
from 7 to 24 points on a 0- to 100-point scale; for func- these studies, 19 (n = 2674; range, 36 to 323) were
tion, 1 trial reported an 8-point difference on a 0- to included in a systematic review of manipulation for
100-point scale and 2 trials reported differences of 0.8 acute low back pain (86) and 26 (n = 6070; range, 29 to
and 3.4 points on the RDQ. In the long term, 2 trials 1334) in a systematic review of manipulation for chronic
showed small or no clear differences. Acupuncture also low back pain (87), and we identified an additional 16
6 Annals of Internal Medicine • Vol. 166 No. 7 • 4 April 2017 Annals.org
that higher-intensity multidisciplinary rehabilitation and shoe insoles (129), or compare nonpharmacologic
seemed to be more effective than lower-intensity pro- therapies with surgical or interventional procedures.
grams, a stratified analysis based on currently available Limitations also existed in the evidence base. Ef-
evidence (54) did not find a clear intensity effect. Our fects on pain and function typically were reported as
findings generally are consistent with recent systematic mean differences at or shortly after intervention, mak-
reviews not included in our evidence synthesis (106 – ing it difficult to determine whether benefits were sus-
117). Although harms were not well-reported, serious tained. Few studies reported the likelihood of clinically
adverse events were not described. significant improvements (130). For each intervention,
As detailed in the full report, we found little evi- trials were heterogeneous regarding the techniques
dence to support the use of most passive physical ther- used, the number of treatment sessions, and the dura-
apies (such as interferential therapy, short-wave dia- tion or intensity of sessions. For example, acupuncture
thermy, traction, ultrasound, lumbar supports, taping, trials varied in needling sites; the length, number, and
and electrical muscle stimulation) for low back pain (5). duration of acupuncture sessions; and the type of sham
Exceptions were superficial heat, which was more effec- treatment (for example, nonpenetrating needles at the
tive than a nonheated control for acute or subacute low acupuncture site vs. penetrating needles at the nonacu-
back pain (SOE, moderate), and low-level laser therapy, puncture site) (58, 59). For many nonpharmacologic in-
which was more effective than sham laser for pain terventions, effectively blinding patients or care provid-
(SOE, low) (118 –120). ers to treatments is difficult, so some observed effects
We categorized the magnitude of effects for pain might have been the result of nonspecific effects re-
and function by using the thresholds in the ACP/APS lated to needling, massage, manipulation, or other
review. Effects classified as small (for example, 5 to 10 treatment administration aspects (such as attentional or
points on a 0- to 100-point scale for pain or function) placebo effects) (131, 132).
are below some proposed minimum thresholds for clin- In conclusion, several nonpharmacologic therapies
ically important differences (such as 15 points on a 0- to for low back pain were associated with small to moder-
100-point VAS for pain, 2 points on a 0- to 10-point ate, primarily short-term effects on pain. Effects on
numerical rating scale for pain or function, 5 points on function generally were smaller than those on pain, and
the RDQ, and 10 points on the Oswestry Disability In- most evidence was for chronic low back pain. New ev-
dex) (12). Factors that may support the use of interven- idence supports the effectiveness of mind– body inter-
tions associated with small effects include low risk for ventions. More research is needed to identify effective
harms, low costs, and strong patient preferences. The nonpharmacologic treatments for radicular and acute
magnitude of effects may vary depending on baseline low back pain and to understand the incremental ben-
severity (121); most trials enrolled patients with at least efits of combining interventions, as well as which treat-
moderate pain (for example, rated as >5 on a 0- to ment combinations and sequences are most effective.
10-point numeric rating scale).
Our findings have implications for clinical practice. From Oregon Health and Science University, Portland, Ore-
Current guidelines do not include mindfulness-based gon, and University of Washington, Seattle, and Spectrum Re-
stress reduction, which was as effective as cognitive be- search, Tacoma, Washington.
havioral therapy for chronic low back pain (45). Recent
guidelines recommend nonopioid over opioid therapy Disclaimer: The authors of this manuscript are responsible for
for chronic pain; yet access to and reimbursement for its content. A representative from the Agency for Healthcare
certain nonpharmacologic therapies remain limited Research and Quality (AHRQ) served as a Contracting Off-
(122, 123). For acute low back pain, most patients im- icer's Technical Representative and provided technical assis-
prove with or without therapy. Therefore, strategies tance during the conduct of the full evidence report and pro-
vided comments on draft versions of the full evidence report.
that target effective therapies to patients at higher risk
The AHRQ did not directly participate in the literature search,
for chronicity may be most efficient (124).
determination of study eligibility criteria, data analysis or in-
Our review had limitations. Because of the large
terpretation, or preparation, review, or approval of the manu-
number of interventions, reviewing all of the primary script for publication. Statements in the report should not be
literature was not feasible. We included higher-quality, construed as endorsement by AHRQ or the U.S. Department
recent systematic reviews that were most relevant to of Health and Human Services. The AHRQ retains a license to
the review scope (125), supplemented with additional display, reproduce, and distribute the data and the report
primary trials. We did not update meta-analyses re- from which this manuscript was derived under the terms of
ported in systematic reviews, but we qualitatively eval- the agency's contract with the author.
uated the consistency of results from new trials against
pooled estimates. We excluded non–English-language Grant Support: By contract HHSA290201200014I from AHRQ,
articles and did not search for abstract-only publica- U.S. Department of Health and Human Services.
tions. We were limited in our ability to assess for pub-
lication bias because of the small numbers of trials for Disclosures: Dr. Chou reports grants from AHRQ and funds
most comparisons, methodological limitations, and for manuscript preparation from ACP during the conduct of
study heterogeneity. We did not address some non- this study. Dr. Deyo reports grants from AHRQ during the
pharmacologic interventions, including education (126, conduct of the study; grants from the National Institutes of
127), advice to remain active (126, 128), mattresses, Health (NIH), AHRQ, Centers for Disease Control and Preven-
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