Low Dose Opioids Ineffective for Acute Lower Back and Neck Pain

By Pat Anson, PNN Editor

A low dose of prescription opioids works no better than a placebo in relieving acute lower back or neck pain, according to a new study in Australia.  

The blinded, placebo-controlled trial was relatively small – just 345 participants – but was unusual because patients were followed for up to a year, a rarity for a clinical trial that studies pain.  Half the participants received a combination of oxycodone and naloxone for six weeks at a low daily dose of 20mg or about 30 morphine milligram equivalents (MME). The other half received placebo tablets that looked similar to oxycodone.   

It's important to note that the study only included people with mild or moderate pain of less than 12 weeks duration -- not the severe, long-term back and neck pain caused by degenerative disc disease, spinal injuries, arthritis, and other chronic conditions. Participants were excluded if they had that type of pain.  

The study findings, published in The Lancet, showed no significant difference in pain severity between the opioid and placebo groups. On a scale of zero to 10, the average pain score was 2.8 in the opioid group after six weeks, compared to 2.3 in the placebo group. After a year, the average pain score was 2.4 in the opioid group, versus 1.8 in the placebo group. 

Pain Severity Over 52 Weeks

THE LANCET

Researchers say patients who received opioids had a slightly higher risk of opioid misuse at the end of the study, a finding based on a mental health survey that screens patients for drug related behavior.

“Our findings show that even judicious, short-term use of an opioid conferred no benefits in pain reduction and led to a small increase in pain at the medium-term and long-term compared with placebo. The opioid group had worse quality-of-life mental health scores than the placebo group,” researchers reported. “Although no difference was found in overall time to recovery, more people in the placebo group recovered in the first 14 days compared with those in the opioid group.”

Most medical guidelines recommend exercise and over-the-counter pain relievers for short-term back or neck pain, with opioids only used as a last resort. The authors of the Lancet study say even that limited use is inappropriate.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney. “Not even when other drug treatments are not able to be prescribed or have not been effective for a patient.”

The Lin study is somewhat similar to the 2018 Krebs study, which found that low doses of oxycodone were no more effective than over-the-counter pain relievers in treating chronic back and osteoarthritis pain. Critics say the Krebs study was biased from the start and this one is no better.

“They generalise enormously,” Michael Vagg, MD, Dean of Pain Medicine at the Australian and New Zealand College of Anaesthetists, told the Medical Republic. “They studied oxycodone and naloxone in a modified-release formulation. But modified-use opioids have never been on-label for use in acute pain and they are not recommended as such… to which I and everyone in pain medicine would say ‘We figured that out ages ago’. That’s not how you use opioids in acute pain.

“In layman’s terms, they’ve done a study where they tried to look at doing push-ups to help with back pain and then they’ve decided that all exercise is no good for the back pain.”

Lower back pain is the world’s leading cause of disability and neck pain is the fourth largest, but there is surprisingly little evidence about the best ways to treat them.

A previous study published in The Lancet by an international team of researchers found that lower back pain was often treated with bad advice, inappropriate tests, risky surgeries and painkillers. The authors said there was limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) were not recommended at all. Most patients responded better to physical and psychological therapies that kept them active.

Mindfulness Program Reduced Chronic Pain and Opioid Use

By Pat Anson, PNN Editor

A mindfulness therapy program reduced chronic pain and emotional distress in patients on long-term opioid therapy, in what’s being touted as the first randomized clinical trial to demonstrate the effectiveness of psychotherapy in reducing pain and opioid use simultaneously.

Researchers at the University of Utah enrolled 250 patients being treated for chronic pain at primary care clinics in the Salt Lake Valley. Most participants took oxycodone or hydrocodone, reported two or more painful conditions, and met the clinical criteria for major depression. Over two-thirds had also been diagnosed with opioid use disorder.

Study participants were randomly assigned to either a standard psychotherapy support group or a mindfulness program called Mindfulness-Oriented Recovery Enhancement (MORE). Both groups met for 8 weekly two-hour sessions. Patients in the MORE group were trained to meditate on their breathing and body sensations, and to practice 3 minutes of mindfulness before taking opioid medication -- focusing on whether their opioid use was due to drug craving or the need for pain relief.

The study findings, published in JAMA Internal Medicine, showed sustained and significant reductions in pain symptoms, depression and opioid use in the MORE group nine months after treatment ended. Researchers say 45% of MORE participants were no longer misusing opioids (compared to 24% in the support group) and 36% had cut their opioid use in half.

“MORE demonstrated one of the most powerful treatment effects I’ve seen,” lead author Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development at the University of Utah, said in a press release. “There’s nothing else out there that works this well in alleviating pain and curbing opioid misuse.”

Garland believes the sustained benefits of MORE might be related to the program’s ability to restructure the way the brain processes rewards, helping patients shift from valuing the physical and psychological effects of drugs to valuing natural, healthy rewards like a beautiful sunset or the smile on the face of a loved one. 

“Remarkably, the effects of MORE seem to get stronger over time,” said Garland, who has been studying mindfulness for over a decade. “One possible explanation is that these individuals are integrating the skills they’ve learned through MORE into their everyday lives.”  

MORE participants are taught to reevaluate the experience of pain and opioid craving, “zooming in” on what they are feeling and breaking it down into different sensations like heat, tightness or tingling. They learn how those experiences change over time, and to adopt the perspective of an observer.

“Rather than getting caught up in the pain or craving, we teach people how to step back and observe that experience from the perspective of an objective witness,” Garland explained. “When they can do that, people begin to recognize that who they truly are is bigger than any one thought or sensation. They are not defined by their experiences of pain or craving; their true nature is something more.”

Garland said the findings are particularly noteworthy because many participants had multiple chronic pain conditions, were on high-opioid doses and also had psychiatric disorders. The average pain duration of participants at the start of the study was nearly 15 years and their average pain score was 5.5 on a 1 to 10 pain scale.

The Opioid Risk Tool Has Been Weaponized Against Pain Patients

By Dr. Lynn Webster, PNN Columnist

I was surprised and deeply disappointed to learn this week that people have been denied opioid prescriptions due to their responses on the Opioid Risk Tool (ORT).

As a guest on the DPP Rally Talk Show with Claudia Merandi, I heard from a caller who told me that her doctor denied her an opioid prescription based on her ORT answers.

One particular answer seems to have caused the caller’s problem: She acknowledged her history of experiencing preadolescent sexual abuse. Apparently, the doctor used that as a reason to deny her access to opioid medication to treat her pain. This is a terrible misapplication of the tool.

The ORT is a self-assessment tool I developed and published about 15 years ago. It was developed at a time when we didn’t know the rate of opioid abuse in patients who were prescribed an opioid for noncancer pain. We needed a tool to help evaluate whether the risk of potential harm from opioids outweighed the good.

I never intended for doctors to use the ORT to determine who should or shouldn’t be prescribed an opioid. My goal was to help doctors identify patients who were at increased risk of misuse and addiction, so that they could receive more careful observation during treatment.

Since abuse and addiction are diagnosed by observing atypical behaviors, knowing which patients are at greatest risk for displaying those behaviors is useful in establishing appropriate levels of monitoring for abuse.

I was not alone in the belief that it was critical to assess patients for their risk potential.

In 2009, the American Pain Society and American Academy of Pain Medicine published a guideline for opioid prescribing. Its first recommendation stated: “Prior to initiating COT (chronic opioid therapy), clinicians should conduct a history, physical examination, and appropriate testing, including an assessment of risk of substance abuse, misuse, or addiction.”

Then, in 2016, the Centers for Disease Control and Prevention’s opioid-prescribing guideline recommended that “before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.”

Several other opioid prescribing guidelines also recommended assessing patient risk before initiating therapy. These included the Washington State Department of Health, Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain, the American Society of Interventional Pain Physicians (ASIPP) Opioid Guidelines, and others.

Risk Factors for Opioid Abuse

Assessing the risk of developing opioid abuse is based on genetic and environmental factors, just as it is with other diseases. Accordingly, the ORT includes questions about family and personal history of substance abuse, since both areas contribute to genetic and environmental factors. 

Genetics are estimated to contribute between 50 to 60% of an individual's vulnerability to opioid addiction. By contrast, genetics contribute only about 30% to a person's vulnerability to marijuana.

A person with one addiction is seven times more likely to develop an addiction to a different class of drugs, so genetics plays a major role in determining who will and who will not develop an opioid use disorder (OUD). Additionally, life experiences -- which are part of one’s environment -- also play a role.

The ORT asks if there is a history of experiencing preadolescent sexual abuse. Studies indicate that preadolescent sexual abuse is believed to result in something clinically similar to post traumatic stress disorder (PTSD).

The National Institute of Drug Abuse (NIDA) has reported that 30 to 60% of women who are undergoing drug abuse treatment suffer from PTSD. One treatment center in New York City reports that more than 90% of women treated for substance abuse had experienced sexual or traumatic abuse. 

According to another NIDA report, victims of rape were 10 times more likely to have abused heroin and other stimulants than the general population. A study in 2000 also showed that a history of preadolescent sexual abuse tripled the risk of drug use disorders.

Many other studies have corroborated these studies, showing that preadolescent sexual abuse is a risk factor for substance abuse later in life. The most important of these is the seminal CDC-Kaiser Permanente Adverse Childhood Experience Study.

A Cruel Misapplication of ORT

Environmental and genetic factors should influence how closely a patient's opioid use is monitored. However, a history of experiencing preadolescent sexual abuse does not mean a person will necessarily develop an OUD. It is only a risk factor. It does not determine the outcome of using opioids, although it may partially indicate the level of monitoring, support, and education that would be appropriate.

It is a cruel misapplication of the ORT to use a background of sexual abuse as the only criterion to assess whether a patient should receive opioid therapy. The ORT is an important tool in mitigating harm that prescribing opioids could cause. It should not be weaponized to justify denying people in pain appropriate therapy. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find him on Twitter: @LynnRWebsterMD. 

The information in this column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.