Steroid Injections May Worsen Knee Arthritis

By Pat Anson, PNN Editor

Two new studies are raising doubts about a commonly used treatment for knee osteoarthritis, a progressive and painful condition found in many older adults. Corticosteroid injections in the knee are often used to relieve osteoarthritis pain by reducing inflammation in the joint, with the relief lasting for days, weeks or sometimes months.

But a new long-term study by researchers at the University of California, San Francisco (UCSF) found that corticosteroid injections appear to worsen the progression of knee osteoarthritis compared to patients who received injections of hyaluronic acid, a polymer gel that acts as a lubricant and shock absorber.

UCSF researchers followed 210 patients with knee osteoarthritis (OA). Seventy of the patients received injections of either corticosteroids or hyaluronic acid, while the rest received no injections and served as a control group. MRI scans were performed on all participants at the start of the study and again two years later, focusing on the meniscus, bone marrow lesions, cartilage, joint effusion and ligaments.

“This is the first direct comparison of corticosteroid and hyaluronic acid injections using the semi-quantitative, whole organ assessment of the knee with MRI,” said Upasana Upadhyay Bharadwaj, MD, a research fellow in the Department of Radiology at UCSF.

In findings presented this week at the annual meeting of the Radiological Society of North America (RSNA), Bharadwaj reported that corticosteroid injections were significantly associated with the progression of knee OA, specifically in the lateral meniscus, lateral cartilage and medial cartilage.

Hyaluronic injections were not associated with the progression of knee OA. Patients who received hyaluronic acid showed a decreased progression of osteoarthritis, specifically in bone marrow lesions, compared to the control group. 

The findings are important because osteoarthritis is the most common form of arthritis, causing progressive joint damage and thinning of cartilage.  Over 32 million U.S. adults have knee OA, and about 10% of them receive corticosteroid or hyaluronic injections.

“While both corticosteroid and hyaluronic acid injections are reported to help with symptomatic pain relief for knee osteoarthritis, our results conclusively show that corticosteroids are associated with significant progression of knee osteoarthritis up to two years post-injection and must be administered with caution,” Bharadwaj said. “Hyaluronic acid, on the other hand, may slow down progression of knee osteoarthritis and alleviate long term effects while offering symptomatic relief.

“Knowing the long-term effects of these injections will help osteoarthritis patients and clinicians make more informed decisions for managing the disease and the pain it causes.”

In a second study presented at the RSNA’s annual meeting, researchers at the Chicago Medical School compared X-ray images of 50 patients with knee OA who received injections of corticosteroids to 50 patients who received injections of hyaluronic acid. Another 50 patients who had no injections served as a control group. Like the UCSF study, X-rays of all patients were taken at the start of the study and again two years later.

The findings mirrored those found in the first study. Patients injected with corticosteroids had significantly more osteoarthritis progression, including medial joint space narrowing, a hallmark of the disease.

“Even though imaging findings for all patients were similar at baseline, the imaging hallmarks of osteoarthritis were worse two years later in patients who received corticosteroid injections compared to patients who received hyaluronic acid injections or no treatment at all,” said Azad Darbandi, a researcher and medical student.

“The results suggest that hyaluronic acid injections should be further explored for the management of knee osteoarthritis symptoms, and that steroid injections should be utilized with more caution.”

The Mayo Clinic recommends that corticosteroid injections be limited to once every six weeks, and that knee OA patients receive injections no more than three or four times a year.

There was a third long-term study presented at the RSNA meeting that debunked another common treatment for knee OA: non-steroidal anti-inflammatory drugs (NSAIDs). UCFS researchers found that NSAIDs worsen inflammation and weaken cartilage in patients with osteoarthritis, contributing to a painful joint condition called synovitis. MRI imaging at the start of the study found joint inflammation and cartilage quality were worse in patients taking NSAIDs, and their knee joints deteriorated even more after four years. 

Steroids Raise Risk of Hospitalization for Sickle Cell Patients

By Pat Anson, PNN Editor

People with sickle cell disease who are prescribed a corticosteroid – an anti-inflammatory medicine often used to treat pain – are significantly more likely to be hospitalized with a severe pain episode, according to a new study.

Sickle cell disease (SCD) is a genetic disorder that causes red blood cells to form in a crescent or sickle shape, which creates painful blockages in blood vessels known as vaso-occlusive episodes (VOE), which can lead to infections, strokes and organ failure. About 100,000 Americans live with SCD, primarily people of African or Hispanic descent.

“Individuals living with SCD often suffer crippling episodes of pain, which can greatly impair their quality of life,” said Ondine Walter, MD, of Toulouse University Hospital in France, lead author of the study published in the journal Blood.

Walter and her colleagues looked at medical data for over 5,100 patients with SCD in the French National Health Insurance Database between 2010 and 2018. Patients had to have at least one hospitalization for VOE to be included, and their corticosteroid exposure was identified using outpatient prescribing records.

Researchers found that patients exposed to a corticosteroid in the month prior to a pain flare were nearly four times more likely to be hospitalized for VOE than those who did not get a steroid. The median time between filling a prescription for a corticosteroid and hospitalization was just five days.

Nearly half the patients (46%) were prescribed a corticosteroid during the study period, an indication of just how common steroid treatment is for SCD. Walter said the results demonstrate the need for better education of clinicians and patients about the potential risks of corticosteroids, especially when there isn’t a clear reason to use them.

“Based on our data, corticosteroids are commonly prescribed for conditions unrelated to their underlying SCD. Vaso-occlusive events and related hospitalization appear to follow corticosteroid prescription fairly quickly. This evidence suggests corticosteroids may be contributing to the events and should be avoided as much as possible in these patients,” Walter said. “Corticosteroids are mostly easy to avoid, and in circumstances when they are necessary, it’s important to start them in collaboration with an SCD expert and to take all appropriate precautionary measures to administer them safely.”

The American Society of Hematology’s Clinical Practice Guideline recommends against using corticosteroids for acute pain in SCD patients.

The French research team also found that SCD patients taking the drug hydroxyurea had about half the risk of being hospitalized for VOE than those not taking it, which may indicate the drug has a protective effect. Hydroxyurea is often prescribed to SCD patients to reduce the number of pain flares and the need for blood transfusions. Men benefited from hydroxyurea more than women and children.

It’s not uncommon for someone with SCD to visit an emergency room a few times each year due to acute pain or complications such as anemia. Many are disappointed by the experience. A 2021 survey of SCD patients in the U.S. found that nearly two-thirds felt ER staff were rude, ignorant or misinformed about sickle cell disease, didn’t take their pain seriously or believed they were drug seekers.

Spinal Injection Bill Would Raise Healthcare Costs

By Pat Anson, Editor

Republicans and Democrats often claim that reducing the cost of healthcare is one of their major goals. But a bipartisan bill that is sailing through Congress with little debate will do just the opposite, raising the cost of some epidural, facet joint and other spinal injections used to treat pain by as much as 25 percent for Medicare beneficiaries.

Critics say the legislation is little more than a money grab by doctors who perform the procedures, under the guise of preventing opioid addiction.

The “Post-Surgical Injections as an Opioid Alternative Act” (HR 5804) is one of nearly 60 bills to combat the opioid crisis approved last week by the House Energy and Commerce Committee. It moves to the full House for a vote.

The bill would partially reverse a decision made by the Centers for Medicare and Medicaid Services (CMS) in 2016 to cut the Medicare reimbursement rate for epidurals and other injections.  The interventional procedures – which do not involve opioids -- can cost several hundred dollars per injection.

The American Society of Interventional Pain Physicians (ASIPP) lobbied unsuccessfully to get the reimbursement cuts overturned – until it found two Illinois Republican congressmen willing to sponsor HR 5804, Rep. John Shimkus and Rep. Raja Krishnamoorthi.

“We first went to the CMS, then HHS, with no success in reversing draconian cuts for interventional techniques. CMS and the administration told us that it requires an Act of Congress,” ASIPP says on its website. “As a first step toward this, Shimkus and Krishnamoorthi have introduced H.R. 5804, which reverses some of the cuts for Ambulatory Surgery Center procedures. This is only the beginning. We have many other cuts to be reversed.”

According to OpenSecrets.org, Shimkus and Krishnamoorthi have both received $10,000 in campaign donations from ASIPP. The organization has spent over $500,000 on lobbying and donations so far in the 2017-2018 election cycle.

‘I Find It Hard to Trust CMS’

Shimkus introduced the ASIPP bill on May 15th and two days later helped shepherd it through its first and only hearing before the House Energy and Commerce Committee.

During the hearing, Shimkus claimed that by cutting the cost of spinal injections, CMS created a disincentive for doctors to perform the procedures and encouraged them to prescribe opioids instead.

“A lot of us were surprised to see CMS reduce the reimbursement rate for non-opioid pain treatments like epidurals for post-surgery pain,” Shimkus said. “I find it hard to trust CMS when those of us in this arena think their cut has led to more opioid use.

“A lot of us believe the inability to use epidurals to treat pain and prescribe opioids is not healthy for our country.”

To be clear, the CMS reimbursement cuts do not prevent any doctor from performing injections – it only made the shots less profitable. And Shimkus offered no evidence that the lower reimbursement rates encourage more opioid use – although he convinced many of his colleagues that they did.  

“I do think it's important in this crisis to be specific with CMS to make sure that we are not discouraging the use of non-opioid alternatives based on reimbursement-related issues,” said Rep. Larry Bucshon, MD (R-IN), who is a cardiologist. “In my experience over the years, CMS makes reimbursement decisions based on the financial incentives to do so, not necessarily, in my opinion, based on what is the appropriate therapy.”

“I don't agree that epidurals are not an alternative (to opioids) already. They are. They are. I just had a conversation with a surgeon about that. So that's not so,” said Rep. Anna Eshoo (R-CA).  “Imagine being able to manage pain without taking an opioid. We could do 20 other things together and it wouldn't equal that."

Rep. Frank Pallone (D-NJ) wasn’t buying any of it.

“I don’t think we have gotten any objective criteria to suggest that what CMS did is going to lead to more people taking opiates,” Pallone said. “I don't think there is any evidence to suggest that this legislation will lead to decreased opioid prescribing or a decreased prevalence of addiction.

“I think we are setting a bad precedent with the bill. I don't think that we, as Congress, are in a good position to pick and choose winners amongst therapies and procedures. I just don't think we know enough to understand the consequences of doing that to understand the relative value and the efficacy of different therapies and procedures on the market.”

Despite those concerns -- and after just 30 minutes of debate that included no public testimony -- committee members overwhelmingly supported the bill by a vote of 36 to 14. Nine Democrats joined with all Republicans on the committee in voting yes.

“What we are doing is temporarily reversing cuts to non-opioid treatment that we all agree save money and lives, then collecting to help ensure we are reimbursing providers at the most appropriate levels possible,” Shimkus said.

“That’s ASIPP talking,” says Terri Lewis, PhD, a researcher and longtime advocate for the pain community. “What does Shimkus know? Shimkus doesn’t know anything. There is no data to support that.”

Health Risks of Spinal Injections

There was no discussion by the committee about the effectiveness of epidurals and other spinal injections -- or of the health risks associated with their use.

Epidural injections have long been used to relieve pain during childbirth, but they are also increasingly being used to treat back pain, despite reports there is little evidence the shots are effective.

The FDA has also warned that the use of steroids in spinal injections – a procedure that’s never been approved by the agency -- “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

“Here we have a procedure that they’re trying to slip under the swimming pool fence that is not FDA approved, that relies on materials that are not regulated and/or contraindicated, and they’re trying to pull a fast one. And they could very easily do it in this climate of opioid hysteria,” said Lewis.

As PNN has reported, some pain management experts believe spinal injections are overused – in part because they’re more profitable for doctors than using opioids or other procedures.  

“Probably everything that gets compensated well is over-utilized because it’s the compensation system. It’s a reimbursement system that pays more for treatment procedures than outcomes,” said Lynn Webster, MD, a past president of the American Academy of Pain Medicine.

A 2012 report by the General Accounting Office – a report requested by Rep. Pallone – found that unsanitary injection practices in ambulatory care clinics expose thousands of patients every year to blood borne pathogens such as hepatitis and HIV.  A perfectly sanitary needle can also go astray and puncture sensitive membranes in the spinal cord, leaving patients with serious and sometimes permanent injuries.      

“When it comes to spinal injections after surgery the risk to the patient, related to adverse events, increases substantially because spine surgery comes with risks of dural tears and accidental cuts,” says Terri Anderson, a Montana woman whose spine was damaged after receiving steroid injections for a ruptured disc in her back.  She now suffers from adhesive arachnoiditis, a chronic inflammation in the spinal membrane that causes severe pain.

“It is unconscionable that harmful injections would be pushed on unsuspecting pain patients,” Anderson said in an email to PNN. “It looks like the large hospital corporations and interventional pain professional societies have been busy lobbying our congressional representatives.  Apparently our healthcare system has become a profitable venture that indirectly contributes to many election campaigns in the U.S.”

No date has been set for a full House vote on HR 5804. To become law, it must pass both the House and Senate and then be signed by President Trump.  There is little opposition to the bill because many critics only recently learned that it was even being considered by Congress. 

“If this is allowed to stand, we have a problem,” says Lewis. “Another thing is Congress directing the practice of medicine. We’ve had just about enough of that.”

Steroid Injections Provide Little Relief for Back Pain

By Pat Anson, Editor

Steroid injections provide only short term relief for patients suffering from chronic low back pain, according to a new study funded by the French Ministry of Health that was published in the Annals of Internal Medicine.

Researchers evaluated 135 patients with discopathy – degenerative disc disease -- who were being treated at three different clinics in France. Half the patients were assigned to a control group and the rest received a single glucocorticoid (steroid) injection into their lower back.

A little over half of the patients who received the injection reported positive effects on back pain after one month. But the effect was only temporary and decreased over time, with no differences in back pain intensity after 12 months when compared to the control group.

“Given these findings, the researchers question the efficacy of glucocorticoid injections as a treatment for chronic low back pain,” the American College of Physicians said in a news release.

The French study adds to a growing body of evidence questioning the effectiveness and safety of steroid injections into the spinal area.

A 2015 report by the Agency for Healthcare Research and Quality (AHRQ) found little evidence that epidural steroid injections were effective in treating low back pain. Researchers said the injections often provide immediate improvements in pain and function, “but benefits were small and not sustained, and there was no effect on long-term risk of surgery.”

A 2014 study by the AHRQ also found that epidural injections did little to relieve pain in patients with spinal stenosis.  

Epidural injections, which have long been used to relieve pain during childbirth, are increasingly being used as an alternative to opioids in treating back pain. The shots have become a common and sometimes lucrative procedure at many pain management clinics, where costs vary from as little as $445 to $2,000 per injection.

The Food and Drug Administration has never approved the use of steroids to treat back pain, but several million epidural steroid injections are still performed “off label” in the U.S. annually.

The American College of Physicians (ACP) recently released new guidelines saying there was little evidence that steroid injections are effective as a treatment for low back pain.

“Moderate-quality evidence showed no differences in pain between systemic corticosteroids and placebo and no to small effect on function in patients with radicular low back pain,” the ACP said.

Lower back pain is the world's leading cause of disability. Over 80 percent of adults have low back pain at some point in their lives.