A new study from Boston University Chobanian & Avedisian School of Medicine, has

found that people with newly diagnosed OA (knee or hip) with contraindications to or precautions for NSAIDs use continue to be prescribed these drugs. Additionally they had higher use of opioids and slightly lower physical therapy (PT) use within the first year of OA diagnosis, both of which are not consistent with treatment guidelines for OA.

“We found individuals with contraindications to NSAIDs were still commonly prescribed them, placing them at risk for NSAID-related adverse events,” explains corresponding author Tuhina Neogi, MD, PhD, the Alan S. Cohen Professor of Rheumatology and professor of medicine at the school. “Additionally, they were not more likely to receive safer alternatives like PT despite its widespread recommendation as first-line intervention.”

The researchers used population-based register data to identify adults residing in Sweden (between 2004-13) without a previous knee or hip OA diagnosis. Among this group, between 2014-18, they identified people with knee or hip OA diagnosis and presence of contraindications to or precautions for oral NSAIDs at the time of OA diagnosis. They then estimated the risk of: 1) regular oral NSAID use; 2) regular opioid use; 3) PT during the first year after diagnosis among those with versus without contraindications or precautions.

Despite having contraindications to NSAIDs, 21% of those in the study were regular users of NSAIDs within the first year of their OA diagnosis. Similarly, 21% of those with precautions for using NSAIDs were also regular users. They also found a higher proportion of persons with contraindications were regular users of opioids than those without a contraindication or precaution, while a slightly lower proportion received PT.

According to the researchers, the lower use of PT use is particularly concerning given that PT and exercise are considered first-line therapy for knee and hip OA by many professional societies. “While PT use within the first year was relatively high in this cohort, likely reflecting the Swedish healthcare system (in which PT is a covered service with minor co-pay from the patient), it is concerning that in a system in which PT services are available and covered that those with NSAID contraindications are still less likely to undergo a PT visit,” added Neogi, who also is chief of rheumatology at Boston Medical Center.

Neogi stresses that more options for effective and safe management of OA symptoms are urgently needed, and greater work is required in narrowing and ultimately closing the evidence-knowledge-practice gap.

These findings appear online in the journal Osteoarthritis and Cartilage.

Funding for this study was provided by the Swedish Research Council (2022-01507), the Greta and Johan Kock foundation, the Hjalmar Svensson foundation, Österlund Foundation, Gustaf V 80-Year Birthday Foundation, Governmental Funding of Clinical Research within National Health Service (ALF), the Swedish Rheumatism Association, the Foundation for People with Movement Disability in Skåne, and the Inger Hultmans foundation, and National Institute of Health (NIH) (P30 AR072571, K24 AR070892).

Tramadol is a synthetic opioid that has been increasingly prescribed for low back pain in the United States (US) over the past decade. While tramadol has a lower potency compared to other prescription opioids, it still carries risks of persistent use and adverse events.

“While previous studies found a reduced likelihood of opioid prescription among those receiving chiropractic care, our study is the first to focus specifically on tramadol,” said Robert Trager, DC, lead author of the study.

The retrospective cohort study, published in BMJ Open, used data from over 2,300 patient records across multiple US academic health centers. It included adults aged 18-50 with a new diagnosis of sciatica, which is characterized by radiating pain, numbness, or weakness in the leg due to a compressed nerve root.

The authors describe extensive efforts to account for differences between the chiropractic and non-chiropractic (usual medical care) cohorts. For example, the cohorts were similar with respect to age, sex, and several other factors. The researchers found that 1.3% of the chiropractic patients received a tramadol prescription over 1-year follow-up, compared to 4.0% of the patients receiving usual medical care.

“As our nation continues to grapple with the opioid crisis, this study reinforces the value of offering patients evidence-based non-pharmacological alternatives for pain management,” said Dr. Françoise Adan, Chief Whole Health and Well-being Officer and Director of UH Connor Whole Health.

Co-author and Resident Physician at Duke University Hospital Roshini Srinivasan, MD, shared that “this work is particularly encouraging to clinicians as we continue to seek safe, effective therapies for conditions that can be complicated to manage, such as chronic low back pain and sciatica.”

The researchers caution that the retrospective design has limitations and call for further research to confirm their findings. In addition, they question whether the findings might be explained by a general effect of visiting a non-pharmacologic clinician, such as a chiropractor, physical therapist, or acupuncturist.

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Reference:

Trager RJ, Cupler ZA, Srinivasan R, et al. Chiropractic spinal manipulation and likelihood of tramadol prescription in adults with radicular low back pain: a retrospective cohort study using US data

BMJ Open 2024;14:e078105. doi: 10.1136/bmjopen-2023-078105

Scientists at the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine) and Nestlé Research in Switzerland led an international collaboration which included contributions from the University of Southampton, University of Melbourne, University of Tehran, University of South Alabama, University of Toyama and University of Copenhagen.

The work, published in Nature Metabolism, builds on a previous collaborative study that described novel mechanisms of human sarcopenia. Sarcopenia is a condition where cellular changes that happen during ageing gradually weaken the muscles in the body and lead to accelerated loss of muscle mass, strength and reduced physical independence.

One important problem during sarcopenia is that the cellular cofactor NAD⁺ declines during ageing, while mitochondria, the energy powerhouses in our cells, produce less energy. The study team discovered that levels of trigonelline were lower in older people with sarcopenia. Providing this molecule in pre-clinical models resulted in increased levels of NAD⁺, increased mitochondrial activity and contributed to the maintenance of muscle function during ageing.

NAD⁺ levels can be enhanced with different dietary precursors like the essential amino acid L-tryptophan (L-Trp), and vitamin B3 forms such as nicotinic acid (NA), nicotinamide (NAM), nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN).

Assistant Professor Vincenzo Sorrentino from the Healthy Longevity Translational Research Programme at NUS Medicine said: ‘Our findings expand the current understanding of NAD⁺ metabolism with the discovery of trigonelline as a novel NAD⁺ precursor and increase the potential of establishing interventions with NAD⁺-producing vitamins for both healthy longevity and age-associated diseases applications.’

Nutrition and physical activity are important lifestyle recommendations to maintain healthy muscles during ageing. ‘We were excited to discover through collaborative research that a natural molecule from food cross-talks with cellular hallmarks of ageing. The benefits of trigonelline on cellular metabolism and muscle health during ageing opens promising translational applications,’ said Jerome Feige, Head of the Physical Health department at Nestlé Research.

In the study, 10 women with and 11 without chronic low back pain underwent an 8‐session yoga program over 4 weeks, with the first session conducted in a clinic and the rest delivered with a tele‐approach. Women with chronic low back pain experienced a significant decrease in pain intensity, as assessed through a 10-point visual analog scale (an average pain of 6.80 at the start, dropped to 3.30 after the sessions) and through a spine-related measure called the flexion–relaxation phenomenon, which is often absent or disrupted in people with low back pain  (5.12 at the start versus 9.49 after the sessions).

The findings suggest yoga can positively impact the neuromuscular response during trunk flexion and pain perception in individuals with chronic low back pain.

“It was interesting to show the role that yoga might play in the management of chronic back pain,” said corresponding author Prof. Alessandro de Sire, MD, of the University of Catanzaro “Magna Graecia” and University Hospital “Renato Dulbecco,” in Italy.

The authors noted that further research is warranted to assess yoga’s long‐term effects.

URL upon publication: https://onlinelibrary.wiley.com/doi/10.1002/jor.25790

About the Journal
The Journal of Orthopaedic Research, a publication of the Orthopaedic Research Society, is the forum for the rapid publication of high quality reports of new information on the full spectrum of orthopaedic research, including life sciences, engineering, translational, and clinical studies.

Investigators selected 129,682 osteoporosis cases and 34,999 major osteoporotic fracture (MOF) cases and matched them with 518,728 and 139,996 controls (without osteoporosis or MOF) by sex and age.

The team found clear dose–response relationships between long-term use of topical corticosteroids and osteoporosis and MOF. For example, compared with no doses, low, medium, and high cumulative of doses topical corticosteroids were associated with 1.22-, 1.26-, and 1.34-times higher odds of developing osteoporosis over five years. These respective doses were linked with 1.12-, 1.19-, and 1.29-times higher odds of experiencing MOF. Women had higher risks of osteoporosis and MOF than men. Also, younger people (<50 years) had a higher risk of osteoporosis compared with other age groups.

“This study emphasizes that using topical corticosteroids to treat inflammatory skin conditions should be done very carefully and clinicians should be aware of these potential side effects,” said corresponding author Chia-Yu Chu, MD PhD, of National Taiwan University Hospital and National Taiwan University College of Medicine.

URL upon publication: https://onlinelibrary.wiley.com/doi/10.1111/jdv.19697

“We found that elevated BMI is associated with more severe flare activity and diminished QOL [quality of life], particularly in obese ERA [early rheumatoid arthritis] patients. This result corroborates earlier studies that suggested a systematic underestimation of disease activity in patients with elevated BMI,” the authors said.

Eligibility for enrollment in the study included a baseline diagnosis of 2 or more swollen joints and Early/Recent Onset RA (symptoms ≤12/≤24 months).

At each clinical visit, the researchers calculated the incidence of flares by using the OMERACT RA-Flare Questionnaire (RA-FQ), a patient reported outcomes (PRO)  that assesses symptoms of Pain, Stiffness, Fatigue, and impacts on Physical Function and Social Participation (items scored from 0 to 10; best to worst). All five scores are summed for an overall score range of 0 to 50.

At each clinical visit they also ascertained an Evaluator Global Assessment (EGA) score, a measure of early rheumatoid clinical disease activity between 0 (not active) and 10 (very active).

Using standard statistical tools they evaluated the data from each visit for the correlation between BMI and RA-FQ scores, adjusting for EGA scores and demographic factors.

The investigators enrolled 134 subjects, 85% female, 71% white and 87% non-Hispanic. Forty-six per cent of the subjects were overweight or obese. The median age was 47.3 years, and the median BMI was 24.3.

They reported that elevated EGA scores and elevated BMI emerged as significant predictors of higher RA-FQ scores.

“Our key finding was that there was a linear relationship between having a higher BMI and having a higher RA-FQ score,” said lead study author Margaret Butler, a research assistant in the Department of Medicine at the Hospital for Special Surgery in New York, NY. “As BMI got higher, RA-FQ scores increased as well, indicating that the patient would have poorer outcomes. Having a higher BMI also predicted worse scores in each of the five individual categories except physical function. The relationship was even more pronounced when you separated patients by healthy BMI, overweight BMI, and obese BMI, with patients having an obese BMI having worse RA-FQ scores compared to the other two groups.”

Study principal investigator Vivian Bykerk, MD, at the Hospital for Special Surgery added, “If a person with RA is experiencing frequent flares, weight could be a contributing factor. “It may be helpful for patients to talk with their doctor about how to lose weight.”

Published in The Lancet, the paper investigated methotrexate, a low-cost, effective treatment for inflammatory joint conditions such as rheumatoid arthritis and psoriatic arthritis. It has been widely used in Australia and globally since the early 1980s.

Researchers found that methotrexate reduced symptoms in those with hand osteoarthritis (OA). A 20mg weekly oral dose over six months had a moderate effect in reducing pain and stiffness in patients with symptomatic hand OA.

Hand OA is a disabling condition that causes pain and affects function, impeding daily activities such as dressing and eating. It can significantly reduce quality of life. About one in two women and one in four men will experience symptoms from hand OA by the time they turn 85.

About half will have inflamed joints, which cause pain and are associated with significant joint damage. Despite the high prevalence and disease burden, there are no effective medications.

Senior author Professor Flavia Cicuttini, who heads Monash University’s Musculoskeletal Unit and is The Alfred’s Head of Rheumatology, said the study identified the role of inflammation in hand OA and the potential benefit of targeting patients who experience painful hand OA.

“In our study, as with most studies of osteoarthritis, both the placebo group and methotrexate groups’ pain improved in the first month or so,” Professor Cicuttini said.

“However, pain levels stayed the same in the placebo group but continued to decrease in the methotrexate group at three and six months, when they were still decreasing. The pain improvement in the methotrexate group was twice as much as in the placebo group.

“Based on these results, use of methotrexate can be considered in the management of hand osteoarthritis with an inflammatory pattern. This provides clinicians with a treatment option for this group, which tends to get more joint damage.”

Professor Cicuttini said in patients with hand OA and inflammation, the effects of methotrexate were present at about three months and by six months it was very clear if it worked.

“At that time patients and their doctors can decide whether to continue or stop it,” she said. “This is very similar to what we currently do with other forms of inflammatory arthritis.”

The NHMRC-funded randomised, double-blind, placebo-controlled trial of 97 people assessed whether 20 mg of methotrexate weekly reduced pain and improved function compared to placebo in patients with symptomatic hand OA and synovitis (inflammation) over six months.

Participants with hand OA and MRI-detected inflammation were recruited from Melbourne, Hobart, Adelaide, and Perth.

Professor Cicuttini said the results could provide relief for people with hand OA inflammation, which was particularly common in women as they experienced menopause.

“Further trials are needed to establish whether the effect of methotrexate extends beyond six months, for how long we need to treat patients, and whether methotrexate reduces joint damage in patients with hand osteoarthritis and associated inflammation,” she said.

Professor Cicuttini now plans to conduct an extension trial to address these questions, in particular whether women who develop hand OA around menopause and often have severe pain and joint damage may benefit.

The study found that cases increased rapidly over the past three decades because of three main factors: aging, population growth, and obesity. In 1990, 256 million people had osteoarthritis. By 2020, this number rose to 595 million people, which was a 132% increase from 1990. By 2050, this number is projected to approach the 1 billion mark.

“With the key drivers of people living longer and a growing world population, we need to anticipate stress on health systems in most countries,” explains Dr. Jaimie Steinmetz, the paper’s corresponding author and lead research scientist at IHME. “There is no effective cure for osteoarthritis right now, so it’s critical that we focus on strategies of prevention, early intervention, and making expensive, effective treatments like joint replacements more affordable in low- and middle-income countries.”

2050 projections of joint pain

The most common areas for osteoarthritis are knees and hips. By 2050, osteoarthritis is projected to increase by the following percentages based on problem areas of the human body.

• Knee +74.9%
• Hand +48.6%
• Hip +78.6%
• Other (e.g., elbow, shoulder) +95.1%

More women than men are expected to continue grappling with this condition. In 2020, 61% of osteoarthritis cases were in women versus 39% in men. There is a combination of possible reasons behind this gender difference.

“The reasons for gender differences in osteoarthritis prevalence are being investigated, but researchers believe that genetics, hormonal factors, and anatomical differences play a role,” explains Dr. Jacek Kopek, senior author and professor in the School of Population and Public Health at the University of British Columbia.

Obesity

This study shows that obesity or high body mass index (BMI) is an important risk factor for osteoarthritis. If obesity can effectively be addressed in the global population, the osteoarthritis burden would decrease by an estimated 20%. The research also shows that obesity has played a greater role over time as rates of obesity have increased.

In the first year of the study in 1990, obesity was responsible for 16% of the disability due to osteoarthritis, which rose to 20% in the year 2020.

“Health care systems and governments have an opportunity to engage and participate in identifying vulnerable populations, addressing drivers of obesity, and developing management strategies to prevent or slow down the progression of osteoarthritis,” says Dr. Liane Ong, lead research scientist at IHME, who supervised and co-authored the study. “The role that physical inactivity plays in obesity and pain associated with osteoarthritis can have opposite and unintended negative cycles. For example, being physically active can prevent injuries earlier in life and can even be beneficial for someone with joint pain. It’s counterintuitive, but having joint pain doesn’t mean we should remain sedentary.”

The study was funded by the Bill & Melinda Gates Foundation, Institute for Bone and Joint Research (IBJR), Global Alliance for Musculoskeletal Health (GMUSC), and the Commonwealth of Australia. The study team included researchers from the Institute for Health Metrics and Evaluation (IHME) in Seattle, Washington and GBD 2021 collaborators from around the world.

https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00163-7/fulltext

The research, published in British Journal of Clinical Pharmacology, found that the KCL-286 drug – which works by activating retinoic acid receptor beta (RARb) in the spine to promote recovery – was well tolerated by participants in a Phase 1 clinical trial, with no severe side effects. Researchers are now seeking funding for a Phase 2a trial studying the safety and tolerability of the drug in those with SCI.

Global prevalence of SCI is estimated to be between 0.7 and 1.2 million cases per year, with falls and road accidents being the major causes. Despite incurring a cost of $4 billion per year in direct healthcare and indirect costs (i.e. inability to work and social care) in the US alone, there are no licensed drugs that can tackle the intrinsic failure of the adult central nervous system to regenerate, and thus remains a largely unmet clinical need.

Previous research by various groups has shown that nerve growth can be stimulated by activating the RARb2 receptor, but no drug suitable for humans has been developed. KCL-286, an RARb2 agonist¹, was developed by Professor Corcoran and team and used in a first in man study to test its safety in humans.

109 healthy males were divided into one of two trial groups; single ascending dose (SAD) adaptive design with a food interaction (FI) arm, and multiple ascending dose (MAD) arm. Participants in each arm were further divided into different dose treatments.

SAD studies are designed to establish the safe dosage range of a medicine by providing participants with small doses before gradually increasing the dose provided. Researchers look for any side effects, and measure how the medicine is processed within the body. MAD studies explore how the body interacts with repeated administration of the drug, and investigate the potential for a drug to accumulate within the body.

Researchers found that participants were able to safely take 100mg doses of KCL-286, with no severe adverse events.

Professor Jonathan Corcoran, Professor of Neuroscience and Director of the Neuroscience Drug Discovery Unit, at King’s IoPPN and the study’s senior author said, “This represents an important first step in demonstrating the viability of KCL-286 in treating spinal cord injuries. This first-in-human study has shown that a 100mg dose delivered via a pill can be safely taken by humans. Furthermore, we have also shown evidence that it engages with the correct receptor.

“Our focus can hopefully now turn to researching the effects of this intervention in people with spinal cord injuries.”

Dr. Bia Goncalves, a senior scientist and project manager of the study, and the study’s first author from King’s IoPPN said, “Spinal Cord Injuries are a life changing condition that can have a huge impact on a person’s ability to carry out the most basic of tasks, and the knock-on effects on their physical and mental health are significant.

“The outcomes of this study demonstrate the potential for therapeutic interventions for SCI, and I am hopeful for what our future research will find.”

This work was possible thanks to funding from the Medical Research Council.

Lead author Dara Lyn LoBuono, PhD, RD, assistant professor in health and exercise science at Rowan University, says, “People with PD are ideal candidates for using digital health platforms because of their decreased mobility, lack of transportation, the need for visual assessment by their health care team, and informal caregivers to be present at health appointments.”

LoBuono conducted the research as a PhD candidate at the University of Rhode Island under the advisement of Ingrid Lofgren, PhD, MPH, RD, professor in the department of nutrition. The study took place in the northeast US during home visits with individuals with PD and their caregivers. Semistructured dyadic interviews with 20 dyads (20 people with Parkinson’s disease and 20 caregivers) were conducted. Researchers used a technology acceptance model and transition theory to inform and guide their development and research. This model provides a basis for understanding external factors influencing end user perceptions, attitudes and intentions to use technology throughout usage.

The research showed that digital health platforms can successfully deliver nutrition services for patients with Parkinson’s disease (PwPD) and their caregivers by personalizing digital services to meet their needs (e.g., disease stage), clearly communicating the benefits of the digital service platforms, training people on how to effectively use the technology (while offering continuous support, when needed), and promoting social interaction with the nutrition expert and members of the PD community while using the digital platform. With the implementation of these findings, digital nutrition service platforms could improve the quality of life for those suffering with PD and their caregivers.

Despite the many benefits of digital health, barriers exist to using these platforms for PwPD. For example, cognitive changes and PD-related tremors can make the software and hardware interface difficult for PwPD.

The authors explain, “Sixteen patients interviewed revealed they did not have access to certain technologies…. [They] did not know how to use some technologies and/or were unsure how they could benefit from technology.”

Additional barriers include difficulties remembering how to operate the devices, concerns around the clarity of information provided, lack of added value, technology being time-consuming, compatibility issues, and privacy concerns.

The authors note, “Overall, findings from this research support developing, piloting, and examining the acceptability and feasibility of a digital health platform to deliver a nutrition service across diverse PD communities that are convenient, include informal caregivers, and minimize participant burden.”

“This achievement demonstrates the commitment by the Department of Orthopaedics to bring new and innovative solutions to advance the quality of orthopaedic patient care,” said Darrel S. Brodke, M.D., Jack and Hazel Robertson Presidential Professor and chair of the Department of Orthopaedics. “It is the dynamic collaboration between our clinical faculty, trainees, our discovery research group and our innovation research group, known as the OIC, that led to this advancement, a first of many to come.”

The FDA granted the Bone Bolt System a 510(k) clearance to sell and market the device in the U.S. This milestone marks the first time that a novel medical device has received an FDA 510(k) clearance in University of Utah’s history.

“As one of the nation’s leading research universities, innovation plays a central role in our mission to improve the quality of life of our patients—OIC’s Bone Bolt System does just that,” said University of Utah President Taylor Randall. “Not only will the device make a difference in the care we can provide at University of Utah Health, but it illustrates our commitment to turn research into real-world impact by getting it to market as soon as possible, to improve health outcomes more broadly.”

The Bone Bolt System is a novel implant system designed and developed by the OIC for percutaneous bone fracture fixation. The system is a comprehensive set of implants of various lengths and diameters, along with associated surgical instruments and sterilization trays. The implants are used to treat challenging bone fractures, such as pelvic fractures and fractures of the long bones in the arm and leg. The Bone Bolt System is protected by U.S. Patent No. 11,553,948, with other U.S. and international patents pending.

The OIC submitted a 510(k) to the FDA to demonstrate that the medical device is safe and effective, or “substantially equivalent,” to an existing FDA 510(k) cleared device. Upon 510(k) clearance by the FDA, the medical device may be legally marketed in the U.S.

The OIC has developed the Bone Bolt System in full compliance with the FDA Quality System Regulations and ISO 13485 Medical Devices—Quality Management Systems. Additionally, the OIC has developed a commercial supply chain for the Bone Bolt System. The next step, to be led by the OIC and the University of Utah PIVOT Center, will be establishing industry partnerships to commercialize the Bone Bolt System and bring it to hospitals and surgery centers throughout the country for the benefit of orthopaedic patients.

“The simplicity of the Bone Bolt procedure to effectively stabilize complex fractures will impact the standard of care for patients with challenging fractures. The thoughtfulness during development of the Bone Bolt System encourages rapid adoption as the development team considered the care provider’s perspective in conjunction with clinical outcomes,” said PIVOT Associate Director of Innovation & Commercialization Huy Tran. “PIVOT Center is looking forward to engaging with potential industry partners to commercialize the technology and make an immediate impact on the quality of life for patients.”

IMAGE: DEMONSTRATION OF THE BONE BOLT BEING USED TO REPAIR A POSTERIOR PELVIC FRACTURE. view more 

CREDIT: WADE FALLIN

The findings were published on June 28, 2023 in The Lancet.

“Despite there being no evidence of their efficacy in reducing pain, opioid pain relievers are still widely prescribed for people with lower back and neck pain in many countries. Our study now suggests that they could be making patients’ pain levels worse in the medium and long term,” said investigator Professor Christine Lin, University of Sydney in Australia and the Sydney Institute for Musculoskeletal Health.

“As well as not providing patients with the pain relief intended, we also know that being prescribed opioid pain relievers even for a short period of time increases the risk of opioid misuse long term. Considering all the evidence and known risks, we firmly believe doctors should not prescribe opioid pain relievers for new episodes of lower back and neck pain,” Lin added.

The OPAL trial was a placebo-controlled randomized trial for which the investigators recruited adults (aged ≥18 years) presenting at primary care or emergency department sites in Sydney, NSW, Australia, within 12 weeks or less of the onset of low back or neck pain (or both) of at least moderate pain severity.

The subjects were randomized to guideline-recommended care plus an opioid (oxycodone– naloxone, up to 20 mg oxycodone per day orally) or guideline-recommended care and an identical placebo, for up to 6 weeks.

The primary outcome was pain severity at 6 weeks; 151 subjects in the opioid group and 159 in the placebo group were included in the primary analysis.

There was no statistically significant difference in the mean pain score at 6 weeks in the opioid group compared to the placebo group (p=0.051).

Subjects given the placebo had slightly, but not significantly, lower pain scores after a year.

Between the cohorts. the risk of opioid misuse was no different at weeks 12 and 26 weeks, but significantly higher in the opioid-treated group after one year, with 20% of the opioid-treated subjects compared to 10% of the placebo-treated subjects scoring “at risk” on the standard Current Opioid Misuse Measure Scale.

The authors concluded, “Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo.”

Writing in a Linked Comment, Mark Sullivan, MD, PhD, Professor of Psychiatry and Behavioral Sciences at the University of Washington in Seattle and Jane Ballantyne, MD, University of Washington, Director of the UW Pain Fellowship. said, “The OPAL trial is a single trial, but it raises serious questions about the use of opioid therapy for acute low back and neck pain. Current clinical guidelines recommend opioids for patients with acute back and neck pain when other pharmacological treatments are contraindicated or have not worked. As many as two-thirds of patients might receive an opioid when presenting for care of back or neck pain. It is time to re-examine these guidelines and these practices.”