Swimming Reduces Disability From Chronic Low Back Pain

By Mark Hancock and Deborah Wareham

As we age, low back pain becomes more common. Between the ages 20 and 59, persistent low back pain (lasting more than three months) affects nearly one in five.

While you may be tempted to reach for heat packs, medication or a massage, new evidence suggests that the common advice to go for a swim is much more effective.

Until recently, there was no research to back up this advice. Our new trial shows for the first time that swimming can improve low back pain.

What We Did

We recruited 76 adults aged 26 to 74 who experienced persistent and bothersome low back pain for more than three months. They needed to be able to swim 25 meters (82 feet) independently, but didn’t swim regularly.

The participants were randomly allocated to receive either a swimming and education program (the intervention group) or education only (the control group).

The intervention involved an eight-week individualised swimming program, supported by four telehealth sessions with a physiotherapist, and free access to a local indoor or outdoor swimming pool.

The amount of swimming was tailored to each participant’s ability and fitness level, with the goal of completing three 30–45 minute swimming sessions per week by the end of the program. Participants were encouraged to continue swimming after the program completed.

The education, provided by a physiotherapist, aimed to help them better understand their pain, reduce the fear associated with movement and exercise, and increase confidence to manage their back pain.

While many people with back pain believe they should avoid activity to protect their back, a large body of evidence shows remaining active is better.

Participants in the education-only (control) group had one to two sessions with a physiotherapist to cover the same key messages about back pain, but otherwise continued their usual treatment and activity.

What Did We Find?

Participants in the swimming group reported improved function, less pain and more confidence to manage future back pain.

Their disability reduced by more than 50% at the end of the eight-week program. This could mean that a person improved their ability to do daily activities such as standing from a chair, walking or sleeping.

The swimming group’s improvements were 30% greater than those who received education only (control) group.

Participants told us swimming appealed to them because it was low-impact, it reduced weight-bearing and strain, and it enabled them to exercise more confidently and with less pain. They also reported additional health benefits, including better mood.

Swimming can be used as a way for people with back pain to start exercising and break the cycle of pain and limited activity.

At the end of the eight-week program, some people kept swimming, others swapped to another form of exercise and some stopped exercising.

Although most participants reported enjoyed swimming, some found accessing a pool and the time required a barrier to keep going in the longer term.

Twelve months after starting the program, there were still benefits for the swimming group for disability, function and confidence. But the difference between groups became smaller over time.

Our study’s sample size was relatively small, so these findings need to be confirmed in future, larger studies.

Further trials are also needed to test whether the results still hold for people with more severe or disabling back pain.

Finally, the volunteers in our study knew we were investigating swimming and had positive expectations of swimming before starting. This is a limitation that could affect the findings.

Swimming vs Other Exercises

A range of different exercises – including Pilates, functional exercises (a type of strength training that helps you perform daily activities) and structured walking – have been shown to be beneficial for treating disability and preventing low back pain recurrences.

While we didn’t compare swimming to another type of exercise, the benefits we identified were as large or larger than previously reported for other exercises.

People with chronic low back pain can now consider swimming as an evidence-based exercise option and be more confident in choosing it as part of their long-term management.

But if you find it a hassle to get to a pool, or don’t like swimming, it may help get your back pain under control before moving to a type of exercise you prefer or can more easily access.

Mark Hancock, PhD, is a Professor of Physiotherapy, Faculty of Medicine and Health Science, at Macquarie University in Australia. 

Deborah Wareham, PhD, is a Research Fellow at the Spinal Pain Research Centre at Macquarie University.

This article originally appeared in The Conversation and is republished with permission.    

First Cannabis-Based Medication for Chronic Pain to Launch in Europe

By Pat Anson

The world’s first cannabis-based medication for chronic pain is expected to launch in Germany and Austria next month after getting marketing authorization from regulators.

Exilby is a full spectrum extract derived from THC, CBD and terpenes found in cannabis sativa, a strain of cannabis that has pain relieving properties. Exilby was approved for treatment of chronic lower back pain, although it’s likely to be prescribed for other chronic pain conditions.

“There is an extra or additional law in Germany, which says for all patients who do not have any adequate treatment left, our drug can be prescribed as well, whether they have low back pain or any other chronic pain condition,” said Dr. Clemens Fischer, founder of Vertanical, which makes Exilby. “We launch at the end of August in Germany and Austria, and then we go to Europe step by step.”

In the United States, Exilby recently received a Breakthrough Therapy designation from the FDA, which will speed up its development and review. But even with that designation, Exilby is not expected to get full FDA approval until 2028 or 2029, due to the slow regulatory process in the U.S.

Much of it hinges on the outcome of a Phase 3 placebo-controlled clinical trial that will evaluate Exilby as a treatment for chronic back pain caused by lumbosacral radiculopathy (sciatica).

Recruitment of 810 patients at various locations in the U.S. is expected to begin in the next few weeks, with the estimated completion date for the study in 2028. If the results are positive, then Vertancal will submit a new drug application to the FDA.

VERTANICAL IMAGE

The recent legalization of medical marijuana in the U.S. creates a faster potential pathway for Exilby. Medical cannabis products already approved at the state level are being reclassified by the DEA as Schedule 3 controlled substances, which allows for some medical use.   

If Exilby were available in state-licensed marijuana dispensaries, it could enter the U.S. market much sooner and without FDA approval. Fischer says he’s tempted, but unlikely to take that approach. 

“We really want to go to the track of having a pharmaceutical and an FDA-approved drug, so this is actually the track we are following. But I think about it. Why not, right? It might be easier,” Fischer told PNN.

In addition to chronic low back pain, Vertanical hopes to eventually get FDA approval for Exilby as a treatment for osteoarthritis and peripheral neuropathy.

In two completed Phase 3 studies in Europe, Exilby was more effective than moderate doses of opioids (27-32 MME) in treating chronic low back pain. Patients taking Exilby also had better sleep quality and were less likely to be constipated. Each dose contains a modest 2.5 mg of THC, but patients did not become “high” or intoxicated.

Cannabis Extract Gets Breakthrough Therapy Status From FDA

By Pat Anson

A German biopharmaceutical company says its cannabis extract has received a Breakthrough Therapy designation from the FDA, which will speed up its development and review as a potential treatment for chronic low back pain. 

If approved by the agency, the investigational extract – called VER-01 – would be the first cannabis-based medicine in the U.S. designated for the treatment of chronic pain. The full spectrum extract is derived from THC, CBD and terpenes found in cannabis sativa, a strain of cannabis known for its pain relieving properties.

"The FDA's Breakthrough Therapy Designation for VER-01 is a major recognition of its potential to address the significant unmet need in chronic pain," Dr. Clemens Fischer, Founder of Vertanical, said in a press release.

"Patients have waited far too long for meaningful progress. We believe VER-01 has the potential to change how chronic pain is treated and offer physicians a much-needed non-opioid solution."

If approved, VER-01 would be sold under the brand name Exilby and be taken orally in drops. The company is also studying VER-01 as a pain treatment for patients with osteoarthritis and peripheral neuropathy. 

The FDA’s Breakthrough Therapy designation was granted after two Phase 3 clinical trials found that VER-01 provided better pain relief to patients with chronic low back pain than low doses of opioids.

Patients taking VER-01 also reported improvements in nerve pain, sleep quality and physical function, and were less likely to be constipated than those on opioids.

Vertanical plans to launch a third Phase 3 placebo-controlled study in the U.S. to confirm the efficacy and safety of VER-01 in patients with chronic low back pain. The company anticipates the first data from that study in 2027 and, if they are positive, plans to submit a New Drug Application to the FDA in 2028.

VERTANICAL IMAGE

Vertanical hopes to get marketing authorization for VER-01 from European regulators in the next few weeks.

Research into the pain-relieving properties of cannabis has long been slowed in the U.S. by marijuana’s status as an illegal Schedule 1 controlled substance. The DEA is now allowing more cannabis to be used for research purposes and recently reclassified medical marijuana as a Schedule 3 drug, which allows for medical uses.

Cannabis Extract Provides ‘Superior Pain Relief’ Compared to Opioids

By Pat Anson

A German pharmaceutical company has released the results of two late-stage clinical trials, showing that a cannabis extract called VER-01 significantly reduces chronic lower back pain. The full spectrum extract, derived from cannabis sativa, provided better pain relief to patients in a head-to-head comparison with low doses of opioids.

Vertanical hopes to get regulatory approval of VER-01 in Europe and with UK regulators in 2026. If granted, VER-01 would be the first cannabis-based medicine approved for use in treating chronic pain. Another study of VER-01 is planned in the U.S. next year, which would be a step towards getting FDA approval.

Findings from the two Phase 3 studies were published separately in the journals Nature Medicine and Pain & Therapy.

“These findings provide powerful evidence that VER-01 could in the future transform how we care for patients with chronic lower back pain,” co-author Charles Argoff, MD, Professor of Neurology at Albany Medical College and past president of the American Academy of Pain Medicine, said in a press release.

“The results of the Phase 3 studies bring hope to millions living with chronic pain that VER-01, once approved, may provide effective pain relief without the risks and harms associated with existing therapies.”

Chronic lower back pain (CLBP) affects more than half a billion people worldwide and is the leading cause of disability. Current treatment options for CLBP are typically limited to physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs), which often don’t work.

In the Phase 3 study, 820 patients with CLBP were given either a placebo or VER-01 over 12 weeks. Those who received the extract had an average pain reduction of 1.9 points on a zero-to-ten pain scale. After six months, pain intensity decreased by 2.9 points, which was sustained over 12 months. Participants also reported improvements in neuropathic pain, sleep quality and physical function.

The other Phase 3 study involved 384 patients with CLBP, who received either VER-01 or opioids for six months. Opioid doses started with a mean daily average of nearly 27 morphine milligram equivalents (MME) and were titrated up to an average of nearly 32 MME, a dosage range that would be considered low or moderate. Opioid options included tramadol, oxycodone, hydromorphone, morphine, and transdermal fentanyl or buprenorphine.

VER-01 was more effective in relieving pain than opioids, especially for patients with severe pain. The average pain reduction with VER-01 was 2.5 points on the pain scale, compared to 2.16 points with opioids. Patients taking VER-01 also had better sleep quality and were less likely to be constipated.

VER-01 was generally well tolerated in both studies, with no evidence of dependence or withdrawal. Side effects such as dizziness and nausea were mild and short-term. Although it contains THC, the main psychoactive substance in cannabis, patients did not become “high” or intoxicated. Each dose of VER-01 contained 2.5 mg of THC, as well as cannabinoids, terpenes and other bioactive compounds that were administered twice daily.

“This study provides robust evidence that VER-01 offers better tolerability, as well as superior pain relief and sleep quality compared to opioids in patients with CLBP. These findings highlight its potential as a promising new pharmacological option within a multimodal treatment approach that could fundamentally shift the paradigm in the treatment of chronic pain,” researchers concluded.

It approved, VER-01 would be sold under the brand name Exilby and be taken orally in drops. Vertanical is also studying VER-01 as a pain treatment for patients with osteoarthritis and peripheral neuropathy.

Research into the pain-relieving properties of cannabis has been slow in the U.S., in large part because of marijuana’s status as an illegal Schedule 1 controlled substance. Although the DEA allows more cannabis to be used for research purposes, the agency has dragged its feet about reclassifying marijuana as a Schedule 3 substance that could be used for medical purposes. Until marijuana is rescheduled, VER-01 is unlikely to get FDA approval. 

WHO Releases First Guideline for Chronic Low Back Pain

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released its first-ever guideline for managing chronic low back pain, recommending treatments such as exercise, physical therapy, chiropractic care and non-steroidal anti-inflammatory drugs (NSAIDs).

Chronic low back pain — also known as “non-specific low back pain” — is defined as pain that persists longer than three months, with symptoms that cannot be accounted for by a structural spinal problem or disease process such as arthritis.

Although lower back pain (LBP) is the leading cause of disability worldwide – affecting about 619 million people – there has been little certainty about how to treat it. Almost all of the clinical trial evidence reviewed by WHO’s guideline development group was considered low or very low quality, a persistent problem.in many medical guidelines dealing with pain.

The lengthy 274-page guideline takes a dim view of some commonly used therapies for LBP, such as muscle relaxants, anticonvulsants, steroids, opioids, transcutaneous electrical nerve stimulation (TENS), and injectable anesthetics – treatments that are primarily used in high-income countries. WHO recommends a more holistic approach to LBP, using therapies that are affordable and accessible to more people.

"Addressing chronic low back pain requires an integrated, person-centred approach. This means considering each person's unique situation and the factors that might influence their pain experience," Dr. Anshu Banerjee, WHO Director for Maternal, Newborn, Child, Adolescent Health and Ageing, said in a press release. "We are using this guideline as a tool to support a holistic approach to chronic low back pain care and to improve the quality, safety and availability of care."

WHO recommends that adults with chronic LBP start with treatments that are the least invasive and least potentially harmful. The values and preferences of patients should also be considered, as they are more likely to adhere to therapies they consider helpful.  

Recommended Treatments for Chronic LBP

• Patient education and counseling

• Exercise or physical therapy

• Acupuncture or dry needling

• Spinal manipulation (chiropractic care)

• Massage

• Cognitive behavioral therapy or mindfulness

• NSAIDs

• Topical cayenne pepper

The guideline states that opioid analgesics “should never be used as a stand-alone treatment” for chronic LBP. When opioids are used alongside other therapies, the lowest dose should be prescribed and only for a short duration, according to WHO.

Recommendations against routine use are also made about many other pharmaceuticals, including antidepressants, anticonvulsants, muscle relaxers, glucocorticoids (steroids), weight loss drugs, and injectable anesthetics such as lidocaine or bupivacaine.  

No recommendations are made about benzodiazepines, cannabis or acetaminophen (paracetamol), primarily due to lack of evidence, but also because of potentially harmful side effects. Cayenne pepper is the only herbal remedy recommended by WHO.

The guideline does not address surgical procedures such as spinal fusions and spinal cord stimulators, or invasive procedures such as epidural injections.

WHO’s 25-member guideline development group included a broad range of clinical experts from around the world. Among them is Roger Chou, MD, a researcher and longtime critic of opioid prescribing who heads the Pacific Northwest Evidence-based Practice Center. Chou is a co-author of the 2016 and 2022 CDC opioid guidelines, and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group. Chou let his Oregon medical license lapse in 2022.

One of the clinical trials reviewed by WHO’s guideline group is a controversial Australian study – known as the OPAL study -- that found low dose opioids gave little relief to patients with short-term back and neck pain. The OPAL study has been panned by critics because the treatment period only lasted six weeks and used a formulation of oxycodone that would not normally be used in clinical practice. Nevertheless, it’s been cited as evidence that “prolonged opioid use” is ineffective.

In 2021, WHO updated its guideline on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill. An earlier WHO guideline that recommended more pediatric use of opioids was withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.