Oct. 25, 2012— -- Helen Bertelli, a mother of two young girls from Raleigh, N.C., has been crippled with weird symptoms -- electric shocks, muscle cramps and the sensation that water is running down her legs -- all since she received an epidural steroid injection for back pain in 2011.
Three months after a medical "fellow" administered the shot at a pain clinic, she had trouble urinating, then both her feet went numb.
"I had this feeling I was connected to the end of a guitar string and someone was plucking it," said Bertelli, 36, and a former runner and hiker. "My legs just exploded like there were fireworks in them. My muscles twitched like they were boiling."
For months doctors told her the knife-like pains were in her head, but six months later, Bertelli was diagnosed with arachnoiditis, an incurable condition that can be associated with epidural steroid injections.
Today, she tells ABCNews.com, "I feel I have been dropped into a nightmare with no hope of waking up."
Arachnoiditis is not fungal meningitis. The outbreak that killed 23 and infected 308 patients nationwide was linked to contaminated steroid solution prepared by a Massachusetts compounding pharmacy.
What Bertelli has is a pain disorder caused by the inflammation of the arachnoid, a delicate spider web-like membrane that surrounds and protects the spinal nerves, spinal cord and brain. The three most common causes are surgery, infection and chemical irritation.
But advocates, including Baker, say that the rising number of epidural steroid injections -- many performed by untrained clinicians -- signals the need for better medical and patient education about risks.
There is some evidence linking the preservatives in steroid medication to arachnoiditis, when the medication is accidentally injected into the spinal fluid. Fluoroscopic (x-ray) guidance is useful with spinal injections, as it confirms needle placement outside of the spinal fluid and allows for safe injection, according to Baker.
"With the right hands, the right skill set and the right patient and the right conditions, they are safe and quite effective," said Baker. "We don't have a lot of policing or oversight to say what are the standards and the rules."
And consumers don't know what a "quality job" is, he said.
"Although the fungal meningitis outbreak is a horrible tragedy, we need to be looking at lessons learned," he told ABCNews.com.
"If any good can come from this, in addition to shining a light on the need for greater oversight of compounding pharmacies, it might be that the media attention on steroid injections will allow patients to become better-informed consumers. For patients, it is buyer beware."
An estimated 5 million epidural steroid injections were performed in the United States in 2011, based on data from Medicare, which pays for about half of all such procedures.
"If I were a patient, I would start asking questions," said Baker. "As with other things in life, skill, training and experience matter. ...For the sake of patient safety, and to maintain public trust, spinal interventions should not be the domain of anyone and everyone."
A patient group, led by Bertelli, has urged the Food and Drug Administration (FDA) to provide more comprehensive training of the practice, better oversight of physicians and better patient consent forms that include arachnoiditis as a potential complication.
She also wants better tracking of adverse events and better guidelines for doctors on contraindications.
FDA Cannot Regulate 'Practice of Medicine'
FDA spokesman Sandy Walsh said "the practice of medicine" does not fall under FDA regulation but is regulated by the states.
"That being said, in a broader sense, FDA does review adverse event reports and notify the public of safety warnings as we learn new information," she told ABCNews.com. "And we do often work with physicians groups and external partners."
She acknowledged that complications from these epidural injections can include, in addition to arachnoiditis, bowel and bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizures and sensory disturbances.
This year, the FDA launched the Safe Use Initiative, working with experts from anesthesiology, orthopedics, neurology/stroke neuro-radiology, pain medicine, and physical medicine and rehabilitation to create guidelines for best practices for transforaminal steroid injections -- those that are administered closest to the spinal arteries.
Experts say the rising number of epidural procedures is due to an aging population that wants to remain more active; an increase in physicians willing to offer them; and word of mouth from patients who say they get relief.
But Bertelli and others who suffer from arachnoiditis say that in hind sight, the risks were too great.
Doctors recommended she get steroid injections in the facet joints on either side of her spinal column after an MRI showed a bulging lumbar disk.
A good friend advised Bertelli not go to a teaching hospital where she had experienced a severe headache after a student administered her epidural.
Instead, Bertelli went to a pain clinic, but when she lay on the examining table a "fellow" gave the injection as her doctor, an osteopath, watched.
"What can you say when there is a needle in your back," Bertelli said. "After several attempts of stabbing around he found the right place."
"Turns out he had been there for three months and it may have been his first injection," she said. "I cried and was in so much pain."
A week after the procedure she experienced, "a burning in the back," and it got worse, preventing her from sleeping. Within three months her entire saddle region went numb.
Despite medications for nerve damage, the pain continued. Doctors misdiagnosed Bertelli with fibromyalgia, and even her husband didn't believe her symptoms were real.
Eventually, she found support from other patients on Facebook -- Life With Arachnoiditis -- and got a diagnosis from Dr. Antonio Aldrete, professor emeritus from the University of Alabama and an authority on arachnoiditis.
Aldrete estimates that as many as 10 to 15 percent of all patients who have epidural steroid injections experience dura perforation. These adverse incidents are "grossly unreported," he said.Aldrete said he bases his findings on clinical work with more than 3,000 patients over 22 years.
"I have personally examined these patients and their radiological images and have their medical records on file," he said. "I can state that all pain management patients whose dura is accidentally punctured during attempted epidural and when steroid (Depomedrol, Kenalog) is deposited subarachnoid, develop arachnoiditis."
"It's not a new disease," he said. "They have found it in mummies in Egypt, caused by TB, syphilis and infections to the spine."
Epidural steroid injections make patients "feel better for awhile," but are being abused in the field of pain management, he said.
"Most go alright, but the ones that go wrong can cause tremendous injury," said Aldrete. The preservatives in steroids can be "toxic" to spinal nerves.
Arachnoiditis After Childbirth
Epidural injections for anesthesia in childbirth are also associated with arachnoiditis when a doctor inadvertently punctures the dura and a blood patch is used to close up the hole. Dura punctures happen about 4 percent of the time in childbirth.
"It is an irritant to nervous tissue -- even a mother's own blood -- and can produce inflammation and clumping of nerve roots," said Aldrete.
"The picture is painted to them that there are no problems," said Aldrete of the 1.6 million pregnant women who have epidurals for delivery.
"We should let the patient know what complications can occur," he said.
Many doctors tell patients that the worst outcome is that epidural steroid injections "may not work," rather than spelling out the risks.
Anesthesiologist Baker argues that overall, the risks of accidental dural puncture are small, according to medical literature -- about 0.3-1 percent. In obstetrical patients using a "blind" (without an x-ray) technique, the risk rises to 1 percent.
In one Japanese study of 277 patients, none of the 89 patients who received steroids in their spinal fluid because of dural puncture developed arachnoiditis.
Baker estimates at most, the odds of getting arachnoiditis are about 1 in 50,000.
Some studies have shown an association between arachnoiditis and exposure to herpes or cytomegalovirus, according to Bertelli.
Two-thirds who develop the condition end up losing bowel or bladder function and some end up bedridden, requiring powerful opiates.
Such was the case with Matt Clark, a 41-year-old father of two from Tennessee. Just hours after receiving an epidural steroid injections for back pain in 2003, parts of his intestines had dropped into his underwear because the epidural had relaxed the muscles in his gut.
Now, felled with arachnoiditis, he is disabled, in permanent pain with stabbing nerve pain in his feet and limbs and the sensation of invisible insects crawling on his skin.
"I am in so much pain," said Clark. "I have been robbed of so many things, and I am told that it is only a matter of time before I am in a wheelchair. I don't want to hurt my family but I truly would pick death over this disease."
He has even considered suicide. "But I can't do that to my boys," said Clark. "They look up to me and love me so much."
Clark compares the overuse of spinal injections to the lobotomies of an earlier century.
"Everyone thought they were a godsend," he said. "Epidural steroid injections are the same thing. Everyone thinks they are wonderful, but they are not. I am going to have this for the rest of my life. It's horrible."
Bertelli, whose condition has stabilized with medications, said she feels the same way. She is still in pain and has spent thousands of dollars on treatments.
"I would not wish this on anyone," she said. "It's been the worst experience of my life and so hard, especially on my loved ones. I am living with the pain, but it hits you and you try not to cry and maintain a smile -- it's important with little kids.
- Questions to ask your doctor before receiving an epidural steroid injection [From Dr. Ray M. Baker]:
- What is the provider's training? Fellowship trained? Weekend course? Mentored?
- Do they use fluoroscopy on all injections?
- Have they had major complication(s)? How many?
- What percentage of their practice is dedicated to interventions?
- Do they occasionally perform spinal injections as a small part of a busy radiology, psychiatry, surgical or pain practice, or are spinal interventions a larger part of their practice?
For support and more information, go to Arachnoiditis USA or The A WordArachnoiditis Society for Awareness and Prevention