Clinical Context

Low back pain is ranked as the number 1 cause of disability worldwide by the Global Burden of Disease Study; it is second only to acute upper respiratory infections as a primary symptom presenting to general practitioners. The authors of the current study explain that primary treatment of acute low back pain includes reassurance and simple analgesics. Nonetheless, one-third of patients with low back pain experience a recurrence within 12 months, and 20% to 30% develop chronic pain.

Secondary treatments, including spinal manipulation, structured exercises, and nonsteroidal anti-inflammatory drugs, have not always separated from placebo in clinical trials of patients with low back pain. Meanwhile, all current guidelines for the management of acute low back pain stress patient education as a central feature of therapy. But does it work? The current study evaluates an intensive education program vs a placebo program among adults with acute low back pain.

Study Synopsis and Perspective

Providing intensive education for patients with acute low back pain is no better than placebo for easing discomfort, results of a randomized controlled trial show.

Investigators at the University of Sydney in Australia found that two 1-hour sessions of patient education were no more effective than placebo sessions for improving pain at 3 months.

"Even though we found formalized, intensive patient education was not effective for recent-onset low back pain, simple advice and reassurance still play a role," principal investigator Adrian Traeger, PhD, told Medscape Medical News.

"There is high-quality evidence that brief primary care-based advice can allay fears about low back pain and prevent unnecessary healthcare use. We just don't need to overdo it," he added.

The study was published online November 5 in JAMA Neurology.

Intensity Tested

Recommendations promoting education for low back pain include a series published earlier the year in the Lancet that suggested researchers and policy makers "[d]evelop and implement strategies to ensure early identification and adequate education of patients with low back pain at risk for persistence of pain and disability."

In addition, international guidelines state that primary care physicians should provide advice, education, reassurance, and simple analgesics, if necessary, to address uncomplicated acute low back pain of less than 6 weeks' duration.

Furthermore, a Cochrane Review that assessed acute low back pain supported the effectiveness of intensive education.

However, the investigators note, most guidelines and studies do not include recommendations regarding the intensity of patient education.

In what they describe as the first placebo-controlled study to assess intensive education in this population, the investigators recruited adults who were within 6 weeks of the onset of acute low back pain.

General practitioners and physiotherapists referred study participants. The investigators trained referring clinicians to provide all recruited participants with guideline-based care, which included advice to stay active and to avoid bed rest, as well as information on treatment options, including spinal manipulation and/or simple analgesics.

After exclusions, the investigators randomly assigned 202 people in a 1:1 ratio to receive two 1-hour sessions of either intensive education or placebo education.

The researchers enrolled participants between September 2013 and December 2015. Just more than half (n=103) were women, and the mean age was 45.1 years. Demographic and clinical characteristics between groups were similar.

To standardize the interventions, a coauthor of the study with expertise in pain education trained 2 of the trial clinicians to deliver the patient education component. For the placebo patient education, a different coauthor, a clinical psychologist with expertise in pain management, trained the same clinicians.

Intensive education included a detailed explanation about the biopsychosocial nature of pain, using diagrams, metaphors, and stories. Clinicians also helped this group reframe any unhelpful beliefs about low back pain. They explained the biologic basis and protective nature of acute and chronic low back pain, helped participants evaluate new concepts, and discussed techniques to promote recovery.

Placebo sessions lasted the same amount of time, but did not include any advice or education regarding acute low back pain. In these sessions, investigators encouraged participants to talk about any topic.

Notable Findings

The 0.3-point decrease in pain intensity at 3 months between intensive and placebo education was not statistically significant (95% confidence interval [CI], P=.31).

In the intensive education group, the mean intensity of pain decreased from 6.3 at baseline to 2.1 at 3 months. A similar decrease occurred in the placebo group, going from 6.1 to 2.4.

The investigators also found a small improvement in disability at 3 months. Disability scores rated on a 24-point scale decreased a mean 1.6 points in the intensive education group (95% CI, −3.1 to −0.1; P=.03) compared with baseline. At the same time, the placebo group experienced a mean decrease of 1.7 points (95% CI, −3.2 to −0.2; P = .03).

However, the differences were not clinically meaningful, the researchers note. "The short-term effects on disability, although consistent with those from similar trials, were below published guidance on clinically meaningful effects," they write. In addition, they found no differences in disability ratings between groups at 6 or 12 months' follow-up.

"Our results suggest that offering more intensive patient education to patients with acute low back pain than that provided as part of standard practice does not reduce pain intensity or lead to meaningful reductions in disability," the researchers note.

Dr Traeger and colleagues did find some differences in secondary outcomes, however. Risk for recurrence of low back pain at 12 months, for example, was lower in the intensive education group than in the placebo cohort (odds ratio, 0.44; 95% CI, 0.24-0.82).

Similarly, the intensive education participants were less likely to experience pain interference at 3 months (mean difference, −0.8; 95% CI, −1.5 to −0.1; P = .02) or to seek healthcare (OR, 0.43; 95% CI, 0.19-0.93). Once again, the investigators did not observe differences at 6 or 12 months.

Pain attitude scores were higher at 1 week in the patient education group, with a mean difference of −0.9 (95% CI, −1.2 to −0.5; P<.001).

The investigators also measured reassurance by asking participants: "How reassured do you feel that there is no serious condition causing your back pain?" The mean difference was 1.2 (95% CI, 0.4-2.0; P=.003).

In contrast, intensive education did not emerge as more effective than placebo patient education for reducing depressive symptoms, the incidence of chronic low back pain, or global perceived change.

There was no evidence that out-of-trial therapy confounded treatment effects.

Interestingly, a causal mediation analysis confirmed that patient education reduced catastrophizing and unhelpful beliefs, but these psychologic mechanisms did not reduce pain intensity, the researchers report.

"We felt there was a strong biologic argument for improving beliefs and reducing catastrophizing about pain, that this might be the answer to developing a persistent pain problem," Dr Traeger said. "We were very surprised to discover that it was not."

Surprising Outcome

A lack of significant difference in pain outcomes at 3 months was unexpected, Dr Traeger said.

"Of all interventions available for low back pain, patient education was probably the most promising option to provide in an intensive format early in the condition.

"We knew there was evidence that this approach had pain-relieving effects for patients with chronic pain, and that it was a reassuring intervention for patients with acute low back pain," he said.

The findings also underline the importance of conducting placebo-controlled trials, he said. "Even approaches with a strong biologic rationale and recommended by international guidelines may turn out to be ineffective," he noted.

"Adding complex, time-consuming treatments to primary-care based advice and reassurance is likely to be unnecessary for most patients with acute low back pain," the researchers state.

They plan to continue looking into ways primary care practitioners can best manage acute low back pain. "We are also very interested in novel nervous system-targeted approaches to prevent the development of chronic pain," Dr Traeger said.

"In the meantime, we plan to spread the message that more is not necessarily better for people with acute low back pain, even when it comes to treatments thought to be universally beneficial," he added.

"My main comment or reaction is that this study suggests that the intensive education intervention that they studied doesn't seem to be effective compared to a placebo intervention.... However, all patients received brief advice and education, including persons in the placebo arm," Roger Chou, MD, a professor in the Department of Medicine and Medical Informatics and the Department of Clinical Epidemiology at Oregon Health and Science University School of Medicine in Portland, told Medscape Medical News when asked to comment on the findings.

"So the study doesn't tell us whether standard or brief advice and education is effective or not," he said.

"No guideline that I am aware of recommends the kind of intensive education that this study suggests, so I don't think that the results contradict current guidelines," added Dr Chou, who was an investigator in the series on low back pain published in the Lancet. He also helped formulate Oregon Health and Science University's recently adopted guideline on diagnosing and treating low back pain.

"The study does suggest that intensive education may not add much benefit beyond simple advice, at least the educational intervention they looked at in this study, but there may be other educational interventions or approaches that are more effective, or certain patients who might benefit from more intensive education," Dr Chou said. "We need more research to address these questions."

Dr Chou added that acute low back pain is similar to many health conditions for which most clinicians provide some education, despite the fact that the evidence for the practice "isn't great." High cholesterol, diabetes, hypertension, and depression are examples.

"A patient-centered approach includes helping patients understand their condition and treatment options and is warranted, even when evidence showing clear benefits may be suboptimal," he said.

The Australian National Health and Medical Research Council funded the study. Dr Traeger and Dr Chou have disclosed no relevant relationships.

JAMA Neurology. Published online November 5, 2018.

Clinical Implications

• Low back pain is ranked as the number 1 cause of disability worldwide by the Global Burden of Disease Study; it is second only to acute upper respiratory infections as a primary symptom presenting to general practitioners. One-third of patients with low back pain experience a recurrence within 12 months, and 20% to 30% develop chronic pain.
• Patient education failed to improve pain scores more than placebo in the current study of patients with acute low back pain, and education also failed to improve disability to a clinically significant level. Patient education also failed to significantly improve depressive symptoms or the incidence of chronic low back pain, but it was associated with a lower rate of recurrent back pain.
• Implications for the Healthcare Team: The healthcare team should continue to educate patients regarding the management of acute low back pain, but the current study suggests that intensive education is not worth the resources that it requires.

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