A celebrated back pain management approach developed in Great Britain proved to be a failure in the United States in terms of its overall impact, according to a large randomized controlled trial (RCT) from the state of Washington. (See Cherkin et al., 2018.)
Dan Cherkin, PhD, and colleagues tested a version of the “STarT Back” approach—a form of stratified care—adapted to local treatment options. It involves using a nine-item questionnaire called the “Keele STarT Back Tool” to categorize patients with back pain in primary care medical settings to low-, medium-, and high-risk prognostic groups. (See Table I for further information.) Subjects are then assigned to evidence-based treatments matched to their prognostic profile.
STarT Back has proven consistently successful in clinical trials in the UK. And it has been incorporated into the back pain management approach recommended by the National Institute for Clinical Excellence (NICE)—the standard setter for Britain's National Health Service (see NICE, 2016.)
Cherkin et al. hoped this approach would improve patient outcomes, reduce the prevalence of inappropriate treatments, and increase the uptake of evidence-based therapies in the United States. Unfortunately, it did nothing of the sort.
“A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use,” said Cherkin and colleagues in the study published in the Journal of General Internal Medicine. (See Cherkin et al., 2018.)
Cherkin offered a more candid assessment when he presented the study at the Oslo International Back and Neck Pain Forum.
“We found no effect, despite strong leadership and clinician support, and the allocation of substantial resources.”
“Basically, the intervention was a complete bust,” said Cherkin. (See Cherkin, 2017.)
A Glimmer of Hope
Although the overall STarT Back approach was a failure in the MATCH RCT, one component of the STarT Back intervention was successful—and might provide a glimmer of hope for the future of STarT Back in the United States.
A second study by Pradeep Suri, MD, and colleagues looked at the predictive validity of the STarT Back tool and found it was accurate in identifying patients at low, medium, and high risk of developing persistent disabling low back pain. So Suri is hopeful that at least part of the STarT Back approach will prove valuable in the United States. “I think there is much potential for the STarT Back approach to be useful in US primary care settings,” Suri commented recently. (See Suri et al., 2018)
(See related article, and further comments from Suri, in the article “Part of the STarT Back Intervention Was Successful” on page 100.)
Holy Grail of Back Pain
By way of background, the development of risk stratification tools such as STarT Back to identify patients at elevated risk of developing chronic disabling back pain is one of the most provocative areas of spinal medicine.
As articles in The BackLetter have pointed out, these tools and associated therapeutic approaches constitute the potential “Holy Grail” of back pain management methods. If they live up to their promise, they hold the possibility of making back care more predictable, more effective, and more cost-effective.
This approach might allow the identification and treatment of the small minority of high-risk patients who would benefit most from targeted psychosocial and physical interventions. And healthcare providers might be able to inform the low risk patients that they have a favorable prognosis—and don't need much of anything in terms of evaluation, advice, or treatment.
As a result, STarT Back appears to hold the potential to reduce both undertreatment and overtreatment.
STarT Back was developed in an impressive series of studies in Great Britain. These included large randomized controlled trials, cost-effectiveness analyses, and a variety of other investigations. (e.g., See Hill et al., 2008; Hill et al., 2011; Foster et al., 2014; and Whitehurst et al., 2012.)
The STarT Back tool, and instructions on how to use it, are available for free at the University of Keele in the UK. (See Keele STarT Back Tool, 2018.)
“Research has shown that stratified care for low back pain in primary care can improve clinical outcomes, reduce costs and increase the efficiency of health-care delivery in the UK,” Gail Sowden, MSc, and colleagues noted in a recent review. “The challenge now is to replicate and evaluate this approach in other countries and health care systems and to support services to implement it in routine clinical care.” (See Sowden et al., 2018.)
There has also been some criticism of STarT Back in terms of the broader evidence pattern. Some have suggested that the degree of enthusiasm for STarT Back doesn't line up with its evidence record anywhere in the world except Great Britain. And that perceptions of its value internationally may be exaggerated.
Studies Underway in Multiple Countries
Happily, there are currently research studies underway in several different countries to evaluate the STarT Back approach. Researchers in Denmark, Netherlands, and Ireland have reported some positive results. (See Sowden et al., 2018 for a discussion of the broader evidence pattern.)
However, the MATCH trial by Cherkin et al. may dampen some of the enthusiasm for STarT Back, particularly in countries where it hasn't been studied.
RCT Involving 1701 Patients With Back Pain
The MATCH RCT involved 1701 adult patients (≥18) with low back pain and took place in the Kaiser Permanente Washington healthcare system (formerly Group Health) in Washington State.
Six primary care clinics with onsite physical therapy were pair-randomized to the STarT Back approach or to usual care at those clinics. The clinic pairs were matched according to geographic and socioeconomic characteristics.
The primary care providers in the trial were either MDs (84%) or physician assistants (16%). A substantial majority (85%) had been practicing for at least five years.
The participants underwent focused training in the STarT Back approach. Primary care providers in the intervention had six instruction sessions on back pain management and in-person training in how to use the STarT Back tool (which had been incorporated into the medical record). Physical therapists in the intervention clinics attended five days of intensive training led by Sowden of Keele University.
Key Components of the STarT Back Approach
“Key components of the intervention were incorporating the original version of the STarT Back tool into the electronic health record, identifying recommended treatment options available from Kaiser Permante for patients in each risk subgroup, and training the primary care teams and physical therapists,” according to the study.
The MATCH protocol recommended that low risk patients (roughly 40% of the group) undergo a brief assessment to rule out red flags, listen to patient concerns, and provide reassurance about prognosis. They also received advice on self-care.
The protocol called for “moderate risk” patients (roughly 40%) to have additional care: “In addition to ruling out red flags and encouraging self-care, recommend activating treatments such as physical therapist-led exercise and yoga that could reduce fear of movement. For patients not interested in activating treatments, consider more passive options (acupuncture, chiropractic, or massage therapy) in the hope these treatments will help decrease their pain and prepare them for more active approaches.”
The MATCH approach recommended that the high-risk group have access to additional referral services. One option was referral to physical therapists trained in the MATCH trial methodology and techniques “to offer a systematic approach to the integration of physical and psychological approaches to treatment of people with low back pain.” A second option was referral for cognitive behavioral therapy with a psychologist. However, access to CBT in the healthcare system was limited.
Bleak Results: STarT Back a Bust?
The results were clear. “There were no statistically significant differences between participants in the intervention and control groups for any of the primary outcomes. And there were no differences in any of the secondary outcomes,” said Cherkin in his Oslo presentation.
Although primary care providers in both the STarT Back group and the control group used the STarT Back tool in about 50% of patients, this didn't appear to have any obvious influence on the pattern of treatments.
The researchers hoped the intervention would reduce the overall level of healthcare use for low back pain. “But there was no effect on any measure of back pain-related utilization,” Cherkin explained.
“We had hoped to see an increase in the use of guideline-based treatment recommendations. That did not happen,” he added.
“We had expected to see a decrease in the use of guideline-discouraged treatments—such as opioids, injections, and surgery consults,” he explained. “But that did not occur.”
One major positive result was that the study did familiarize many physicians, nurses, physical therapists and members of other professions with the STart Back tool and the STart Back approach.
Failure May Stem From Many Factors
The failure of the STarT Back approach in the US could have stemmed from many factors. Cherkin pointed out at the Oslo Forum that the US study involved a complex intervention.
“This was a complex intervention with multiple evidence-based options. By contrast, the Keele program [the original version of the STarT Back approach] offered only two physical therapy programs,” he explained.
Another problem is that the US back care system is currently in a state of crisis. There is broad agreement that back care in the US should move away from its current emphasis on analgesics, guideline-discordant treatments, and early referrals for imaging, invasive pain interventions, and surgery.
There is also general consensus that US back care providers should move towards the interventions recommended in the American College of Physicians guidelines for both acute and chronic pain, including exercise, spinal manipulation, yoga, mindfulness-based meditation, and cognitive behavioral interventions. However, because of systemic barriers to change in many healthcare systems, progress towards this goal has been painfully slow.
Unfortunately, the US healthcare system is not currently set up to provide most of these treatments in primary care medical settings—or through easy referral pathways. So some of the failure of the STarT Back intervention could have stemmed from lack of familiarity with the assessment and treatment recommendations—and how to implement these.
Cherkin also pointed out that changing the established behavior of physicians is a challenging pursuit. “Changing behavior is difficult,” said Cherkin in Oslo. He observed that medical care has been consistently found to change slowly despite the availability of clear evidence that change would be beneficial for patients.
And the current situation in US medicine, where there are high levels of overwork, job dissatisfaction, and burnout among primary care providers, may exacerbate this tendency.
Cherkin et al. suggested that future efforts to implement such complex interventions should employ several strategies to encourage success: (1) employ simple, easily implemented, and well supported treatment recommendations; (2) place automatic alerts in the electronic health records to help healthcare providers remember to assess risk stratification information and provide matched treatments. And they would like to see primary care providers receive regular feedback on their use of STarT Back and STarT Back-recommended treatment packages at each level of risk.
Should STarT Back Treatments Be Available In-House?
A BackLetter editor asked Cherkin via email if he was recommending that these treatment interventions should be available in-house so patients wouldn't have to go out and find a yoga teacher, a chiropractor, an acupuncturist, or an exercise physiologist. This might facilitate seamless access to these therapies in future tests of STarT Back and other stratified care approaches.
“Not necessarily in-house,” Cherkin responded. “Having these resources in-house might facilitate seamlessness but relatively few healthcare providers/systems will be capable of doing this. But they should be incorporated into the care processes in a way that is seamless,” he added. And these treatment approaches, he added, should be taken seriously within healthcare systems as part of appropriate care for low back pain.
Disclosures: None declared.
Buchbinder R, et al Low back pain: A call for action, Lancet [published online ahead of print March 20, 2018]. doi: 10.1016/S0140-6736(18)30488-4.
Cherkin D, et al Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care, Journal of General Internal Medicine, 2018; [Epub ahead of print]. doi: 10.1007/s11606-018-4468-9.
Foster NE, Mullis R, Hill JC, et al, on behalf of the IMPaCT Back Study team. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Annals of Family Medicine, 2014;12(2): 102–11.
Foster NE, et al Prevention and treatment of low back pain: Evidence, challenges, and promising directions, Lancet, 2018 [Epub ahead of print March 20, 2018]. doi:10.1016/S0140-6736(18)30489-6.
Hartvigsen J, et al What low back pain is and why we need to pay attention, Lancet, 2018; [Epub ahead of print March 20, 2018]. doi:10.1016/S0140-6736(18)30480-X.
Hill JC, Dunn KM, Lewis M, et al A primary care back pain screening tool: identifying patient subgroups for initial treatment, Arthritis & Rheumatism, 2008;59(5):632–41.
Hill JC, Whitehurst DG, Lewis M, et al Comparison of stratified primary care management for low back pain with current best practice: (STarT Back) [ISRCTN37113406]: a randomised controlled trial. Lancet. 2011;378(9802):1560–71.
National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management (NICE guideline NG59). 2016; http://www.nice.org.uk/guidance/ng59
Sowden G, et al Advancing practice for back pain through stratified care (STarT Back), Brazilian Journal of Physical Therapy, 2018 [Epub ahead of print]; S1413-3555(18)30399-X. doi: 10.1016/j.bjpt.2018.06.003.
Suri P, et al Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S Primary Care Setting, Archives of Physical Medicine and Rehabilitation, 2018 Apr 3; S0003-9993(18)30204-1.
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Whitehurst DG, Bryan S, Lewis M, Hill J, Hay EM. Exploring the cost-utility of stratified primary care management for low back pain compared with current best practice within risk-defined subgroups. Annals of the Rheumatic Diseases, 2012;71(11):1796–1802.