High-Risk, Low-Benefit Treatments for Chronic Low Back Pain Demand Re-Evaluation

Chronic low back pain can be difficult to manage, particularly when patients have tried multiple treatments without achieving meaningful relief. However, some interventions may expose patients to substantial costs and harms while offering little or no benefit over placebo, underscoring the need for clinicians to critically evaluate the evidence behind commonly used medications, procedures, and devices.

In an interview with Pharmacy Times, Caitlin Jones, PhD, postdoctoral research associate at the Institute for Musculoskeletal Health, discusses why high-risk, low-benefit treatments for chronic low back pain require greater scrutiny. Jones reviews the limited benefits and accumulating risks associated with long-term opioid therapy, examines evidence questioning the effectiveness of spinal cord stimulators, and explains how outdated guidelines, conflicted evidence, and health system incentives can influence treatment decisions. She also emphasizes the importance of assessing outcomes that matter to individual patients, distinguishing physiological opioid dependence from addiction, and improving access to lower-risk, multidisciplinary approaches to pain management.

Pharmacy Times: Which treatments for chronic low back pain do you believe clinicians should be re-evaluating most carefully today?

Caitlin Jones, PhD: The treatments that most urgently need re-evaluation are high-risk interventions, including invasive procedures such as surgeries and implants, as well as certain high-risk medications. These treatments can carry substantial risks while providing relatively little benefit.

High-quality randomized controlled trials have shown that many of these interventions offer either no benefit or only minimal benefit. Patients may therefore be taking on considerable risk with little chance of experiencing a meaningful improvement, which raises ethical concerns.

Spinal cord stimulators are a good example. Some lower-certainty and highly conflicted head-to-head studies report benefits with spinal cord stimulation, but high-quality studies comparing the devices with placebo have found no benefit. There is also approximately a 30% chance that a patient will require another surgical intervention because something has gone wrong. These devices can cost upward of AU$55,000, which is approximately US$40,000. High-risk, low-reward interventions such as these are the treatments that most urgently require re-evaluation.

Pharmacy Times: What does current evidence tell us about the long-term risks and benefits of opioid therapy for chronic low back pain?

Jones: For chronic low back pain, opioids provide very small benefits over placebo. On average, the difference is approximately 1 point on a 10-point pain scale, which is around the threshold at which people may be able to detect a difference. Opioids have also not demonstrated benefits over other medications, such as nonsteroidal anti-inflammatory drugs.

The unfortunate reality with many pain medications is that they carry risks, and those risks often increase the longer they are used. Because the benefits are small, taking these medications over the long term for a chronic pain condition is often not worth the accumulating risk.

The risks associated with opioids are particularly well understood. Physiological dependence can develop, the pain-relieving effects may diminish over time, and patients may need progressively higher doses. Higher doses can lead to more adverse effects, such as constipation and dizziness, as well as increased risks of serious outcomes, including addiction, overdose, and death.

Pharmacy Times: Spinal cord stimulators have become increasingly utilized in chronic pain management. What should clinicians and pharmacists understand about their limitations and potential harms?

Jones: Clinicians and pharmacists need to understand that high-quality, blinded randomized controlled trials have shown that spinal cord stimulators are not effective at reducing pain. The increase in their use is being driven, in part, by hype and effective marketing that can masquerade as science.

When patients search for information about these devices, they often encounter websites describing spinal cord stimulation as minimally invasive or as a safe alternative to long-term opioid therapy. However, the procedure involves placing an electrical lead between the vertebrae to deliver electrical impulses to the spinal cord. That lead is powered by a battery implanted in the buttock. I would not describe that as minimally invasive.

The procedure carries risks, including spinal infections and leads becoming displaced as the patient moves, potentially migrating to the wrong location and delivering electrical impulses where they are not intended. Severe injuries have also been reported, including strokes and paralysis associated with complications from the leads.

I understand why someone living with chronic low back pain, particularly someone who has tried many treatments without finding relief, may be willing to accept some risk in the hope of regaining part of their quality of life. However, the way these devices are advertised to patients is often not transparent about the evidence demonstrating that they do not work better than placebo, the seriousness of the potential harms, or the likelihood that additional surgery may be required to correct complications.

I believe that if spinal cord stimulators were presented to patients with complete and honest information about their benefits and risks, very few people would elect to receive one.

Pharmacy Times: What are the most common ways patients may be harmed by well-intentioned treatment decisions?

Jones: Most clinicians and other health professionals have good intentions. It is rare for someone who has completed extensive training and chosen a career in health care to intend to cause harm, although conflicts of interest and problematic incentive structures can influence care.

Clinicians are primarily trained to deliver care, but they may receive less training in understanding, interpreting, and critically appraising research because research appraisal is not their core area of expertise. Clinical guidelines are intended to summarize evidence and help clinicians make appropriate decisions for the individual patient in front of them. However, guidelines are not always available, may be years behind the latest evidence, can include inappropriate recommendations because of conflicts of interest, or may simply be of low quality.

Despite good intentions, harm can occur because clinicians and patients do not always have access to trustworthy, digestible, and up-to-date summaries of the evidence needed to guide treatment decisions. There are good resources available for some conditions, but researchers could do more to communicate evidence quickly and clearly to the people making these decisions.

Pharmacy Times: What warning signs suggest that a patient’s treatment plan may be causing more harm than benefit?

Jones: The most important information often comes from the patient. Clinicians should ask how the patient’s pain is changing, what adverse effects they are experiencing, how bothersome those effects are, how much the treatment costs, whether they can continue to afford it, and how their symptoms have changed over time.

The patient’s perspective on their overall quality of life is also essential. A person may be experiencing adverse effects but still believe that the relief they receive makes those effects worthwhile. That is a personal decision.

Opioids make this assessment more complicated. Anyone who has used opioids consistently for a prolonged period—and, in some cases, for as little as a few weeks—may develop some degree of physiological dependence. Physiological dependence is different from addiction, which involves psychological cravings and other patterns of compulsive use.

When a physiologically dependent patient misses a dose, reduces the dose, or stops taking opioids, they may experience withdrawal symptoms. Patients can misinterpret those symptoms as evidence that the medication was effectively treating their condition, thinking, “The opioid must have been working because I felt terrible when I stopped taking it.” However, what they are experiencing may be opioid withdrawal, and it can be difficult to distinguish withdrawal symptoms from the underlying pain condition.

Patients who want to reduce their opioid use should do so slowly, under careful medical supervision, and with as much support as possible. Tapering must also be consensual. Considerable harm has been caused by withholding or discontinuing opioids without the patient’s agreement.

Pharmacy Times: If you could change one thing about the way chronic low back pain is treated worldwide, what would it be?

Jones: I would change the incentive structures in 2 main ways. First, I would remove the marketing noise that confuses clinicians and patients so that treatment decisions could be based on clear, unbiased data.

In Australia, advertisements for medical interventions are not permitted on television, which helps, but clinicians can still be targeted by marketing. That can muddy the waters when they are trying to interpret the evidence and recommend treatments.

The second change would involve how health systems and funding are organized. Australia has a strong public health care system in which patients can receive medications, surgeries, and injections for free or at a relatively low cost. However, services such as physiotherapy or psychological care often require out-of-pocket payments because they are delivered privately outside the main public system.

When patients are conscious of cost—and most people are—they may be funneled toward medications and surgeries that cost them less out of pocket but provide lower value because their benefits are smaller and their risks are greater.

I would restructure the system so that high-value, low-risk treatments, including allied health and multidisciplinary interventions, were also the most affordable and accessible choices. Patients would then naturally gravitate toward them. At present, the incentives are often backward, and patients may be nudged toward less effective treatments, including certain medications and surgeries.