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New mild® Procedure for Lumbar Spinal Stenosis Returns a Champion to His Game
When 67-year-old Nagy Youssef sought treatment for lumbar spinal stenosis (LSS) at Cleveland Clinic, he couldn’t stand long enough to brush his teeth and could walk no farther than 500 feet before needing to sit down to relieve agonizing back and leg pain.
“In addition to the pain, I was psychologically traumatized to be in this condition,” says Mr. Youssef, an Egyptian athlete who is also known as Nagui Assad and competed in the Olympics in the 1970s and 1980s, holding a world’s record in shotput. Increasing severity of the LSS, an age-related degenerative disease, forced him to significantly scale back his coaching of national track and field teams, and he could no longer participate in routine activities he had taken for granted.
But all of that changed for the better since Mr. Youssef underwent an innovative X-ray-guided outpatient treatment for moderate to severe LSS — the mild® (minimally invasive lumbar decompression) procedure — at Cleveland Clinic last year. “The back pain decreased significantly, and I can now stand for more than 30 minutes and walk four miles,” he says.
Burgeoning Demand — and Medicare Coverage
“The mild procedure reduces pain and increases mobility while maintaining the structural integrity of the spine,” says Nagy Mekhail, MD, PhD, Director of Evidence-Based Medicine in the Department of Pain Management, who performed the procedure on Mr. Youssef.
Medicare began covering mild in July 2012, and a number of private insurers cover it as well.
Like Mr. Youssef, many patients who present with moderate to severe LSS cannot stand longer than a few minutes or walk more than a few hundred feet. The average age for those seeking treatment is 73 years.
“With more than 10,000 baby boomers turning 65 every day, more and more patients are seeking innovative treatments such as mild that will allow them to stay active and maintain their quality of life,” Dr. Mekhail says.
Who’s a Candidate?
LSS may be due to a bulging disc and/or hypertrophy of the ligamentum flavum, which lines the back of the spinal canal. Narrowing of the spinal canal causes nerve compression. When someone with LSS stands or walks, the canal narrows even more, causing neurogenic claudication, or low back and leg pain that is relieved with sitting or bending forward.
Patients who don’t respond to conservative treatment and are not candidates for open spine surgery may benefit from mild if they complain of neurogenic claudication and if MRI shows that a thickened ligamentum flavum is the major cause of the spinal stenosis.
The mild procedure is performed under deep sedation through a 1-cm incision. The clinician uses a special sculpting tool that glides through a portal with a diameter of 5 mm, about the size of a pen cap, to go between the bones, scrape out the ligaments and widen the spinal canal to decrease nerve compression. Patients typically recover quickly and are able to begin walking within the first 24 hours after the procedure.
Enduring Effects to Date
Dr. Mekhail and colleagues recently published findings from a multicenter study of mild (Pain Pract. 2012;12:184-193). Highlights include:
- No major device- or procedure-related complications
- Significant reduction in pain at one-year follow-up
- Improvement in physical functionality and mobility (as measured by walking distance and standing time)
- Decreased disability secondary to neurogenic claudication
As for Mr. Youssef, he is back at work as a coach and able to be more active with his grandchildren and to grocery shop with his wife again. “I feel that my life clock has been rewound to before the year 2000, when the pain started,” he says.
To refer an LSS patient for evaluation for the mild procedure, call 216.444.9114.
Coming this summer: An in-depth look at the mild procedure in our print Pain Consult newsletter.
Expanding Options for Back Pain: Matching Treatments to Causes
Patients with back pain have no shortage of minimally invasive treatment options, many of which are offered by pain specialists in Cleveland Clinic’s Department of Pain Management. The diverse interventions are aimed at restoring function and alleviating pain, even in patients with complex causes of back pain.
When conservative measures (such as oral pain medications and physical therapy) fail to adequately relieve back pain, or if red-flag signs (e.g., weakness) are present, referral for evaluation by a pain specialist should be considered. So says Shrif J. Costandi, MD, staff physician in the Department of Pain Management.
“Back pain can have nonmalignant and malignant causes,” says Dr. Costandi, “and the specific therapy must be matched to the cause.” Below is a rundown of interventions considered by Dr. Costandi and his colleagues based on the underlying cause of back pain.
Nonmalignant Causes
Facet arthropathy is a common cause of axial back pain. If it’s suspected, temporary relief from medial branch blocks can confirm the diagnosis (medial branches are nerves that supply the facet joints and cause pain), at which point pain specialists can proceed to radiofrequency ablation (RFA) of involved nerves for long-term relief. “The average duration of relief from RFA is usually six to nine months,” notes Dr. Costandi.
When radiculopathy is the cause of back pain, epidural steroid injections — either interlaminar or transforaminal — can be effective interventions to facilitate physical therapy and early return to work.
Pain emanating from the sacroiliac (SI) joint can be managed by SI joint steroid injections and physical therapy to strengthen core muscles. If SI joint injections provide relief but the effect is temporary, RFA of the lateral sacral branches may be offered.
Discogenic pain is confirmed with provocative discography, which also identifies the disrupted discs. Two new treatments offered for discogenic pain are biacuplasty and fibrin sealant injections (via the Biostat® System). Biacuplasty with the TransDiscal™ System is a minimally invasive procedure that applies radiofrequency heat through probes to the annulus of the disc to destroy painful nerve fibers. Changes in collagen fibers induced by biacuplasty may also improve disc stability. Fibrin sealant is a biologic tissue that, when applied to a disrupted disc, seals the disruption, restores disc height and encourages tissue repair. The Department of Pain Management is participating in clinical studies of the fibrin sealant; results from data analysis are promising, Dr. Costandi says.
For postlaminectomy syndrome, or persistent pain after spinal surgery, pain relief and improved function may be provided by a multidisciplinary approach that combines injections, physical therapy, psychological support and optimal medical management. If this is insufficient or provides only temporary relief, the patient may be a candidate for a trial of spinal cord stimulation. If the trial improves function and reduces pain and medication requirements, permanent implantation of the spinal cord stimulator is considered. An emerging option under study at Cleveland Clinic and just a few other centers worldwide is dorsal root ganglion stimulation, in which only the dorsal root ganglia at the exiting nerve roots are stimulated (vs. the entire dorsal sensory column of the spinal cord), allowing for more sophisticated stimulation and coverage.
For pain from spinal stenosis, if conservative management is inadequate, the first option is epidural steroid injections plus physical therapy. Decompression surgery has traditionally been considered next-line therapy, but an outpatient procedure called mild® (minimally invasive lumbar decompression) is now available. Objective improvements in standing time and walking distance have been recorded in studies of mild at Cleveland Clinic. “Patients who could barely stand for 10 minutes were up and moving around for several hours following mild,” says Dr. Costandi. “Some patients can walk a mile or two after being able to walk only 200 or 300 feet. Many can drop their canes, too.”
For intractable back pain, delivery of opioids and local anesthetics to the cerebrospinal fluid through an intrathecal pump may be tried as a last option.
Back Pain of Malignant Origin
Vertebral compression fractures can have nonmalignant (osteoporosis) as well as malignant causes. Painful fractures can be treated with kyphoplasty, a minimally invasive procedure in which cement is injected into the vertebral body to restore vertebral height and reduce pain.
Pain from vertebral metastases may be managed by a novel technique using the OsteoCool™ System, which employs water-cooled radiofrequency probes to ablate malignant bone tissue. OsteoCool therapy is an option for patients in whom radiotherapy and opioids provide inadequate relief. “Patients’ pain levels and disability scores were improved significantly,” notes Dr. Costandi.
Choice and Collaboration Are Key
The ability to choose from many interventions is key to successful individualized back pain management, says Dr. Costandi. So is collaboration. “We refer patients to physical therapy to supplement most medical interventions. If there is any psychological component, our patients are seen by a pain psychologist for behavioral modification or stress-coping techniques. A multidisciplinary approach is the best way to deal with chronic pain.”
Dr. Costandi sees patients at Cleveland Clinic’s main campus and the Richard E. Jacobs Health Center in Avon. He can be reached at 216.444.8455.
Patient, Heal Thyself: Analgesic Cell Therapy Could Be a Game-Changer in Chronic Pain
Innovative stem cell research under way at Cleveland Clinic could someday dramatically change the way chronic pain is treated and decrease the potential for prescription drug abuse.
The research is in the early stages of testing whether mesenchymal stem cells, after being harvested from a patient’s bone marrow and reprogrammed into chromaffin-like cells, can provide relief from chronic intractable pain when they are transplanted back into the same patient.
Innovative Approach
The endogenous opioids that are generated from these differentiated chromaffin-like cells have powerful analgesic effects. In fact, they have the potential to treat nerve injury-induced pain that usually doesn’t respond to exogenous opioids such as morphine and its derivatives, according to Jianguo Cheng, MD, PhD, principal investigator of the Department of Defense (DOD)-funded study and Professor and Director of Cleveland Clinic’s Pain Medicine Fellowship Program.
Dr. Cheng and his collaborator, Tingyu Qu, MD, PhD, from the University of Illinois at Chicago, developed the patent-pending technology to differentiate the autologous stem cells into chromaffin-like cells. Initial animal studies have already demonstrated the feasibility of transplanting the cells for pain relief.
The current DOD study in rats is testing safety, analgesic effects and anti-tolerance effects, as well as the longevity and stability of the cells once transplanted. “While many more studies will be needed over many years before this approach can be tested in humans, initial results from animal studies have shown great promise,” says Dr. Cheng. In addition to patients with intractable neuropathic pain, patients with cancer pain could someday be good candidates for this type of therapy, he adds.
Potential Advantages Are Many
If the stem cell therapy is found to be safe and effective, potential advantages include:
- Therapeutic alternative — This approach promises the ability to treat intractable neuropathic pain in patients who don’t respond to prescription opioids.
- Fewer side effects — Patients who opt for analgesic cell therapy could avoid the side effects of exogenous opioids, such as respiratory depression, immune system compromise, disruption or depression of endocrine functions, constipation, vomiting and itching.
- Decreased abuse — Endogenous opioids from analgesic cell therapy serve as an alternative to highly addictive prescription opioids, which cause more deaths than car accidents and are often diverted for illegal use.
- Reprogrammed stem cells — Unlike embryonic stem cells, once the mesenchymal stem cells are differentiated into chromaffin-like cells, they can’t grow or divide, so tumor risk is not an issue.
If this analgesic cell therapy is found to be viable, it has the potential to be a clinical game-changer. As stated in the DOD’s assessment of the grant application: “This approach to pain management is very innovative and, if successful, could have a tremendous impact on the way that chronic pain is treated.”
Save the Date: Cleveland Clinic’s Annual Pain Management Symposium Comes to Las Vegas in February 2014
More than 250 physicians and other providers from 40 states and 12 nations brought themselves up to date on the full spectrum of pain medicine at Cleveland Clinic’s 15th Annual Pain Management Symposium, held in Sarasota, Fla., this past February.
Now course organizers are busy planning for the 16th Annual Pain Management Symposium, to be held Feb. 15-19, 2014, at Caesar’s Palace in Las Vegas.
The comprehensive five-day course provides in-depth reviews and analyses of most major aspects of contemporary pain medicine. This year’s topic categories ranged from emerging technologies to controversies in pain medicine and from evidence-based spine pain care to risk management in pain medicine. Additional program sections were devoted to imaging techniques and updates on headache management.
“This course tackles the provocative issues in pain medicine and challenges attendees to examine the basis for their medical decisions,” says Richard Rosenquist, MD, Chairman of Cleveland Clinic’s Department of Pain Management and one of the faculty members for this year’s symposium.
Content is presented by approximately 40 renowned experts in pain management. About half the faculty comes from Cleveland Clinic and half from other leading U.S. and international medical centers. This year’s faculty included experts from Sweden and the United Kingdom. The agenda is a diverse mix of traditional lectures with problem-based learning discussions, cadaver workshops on novel interventional techniques, and live model workshops for training in ultrasonography-guided injections and peripheral nerve blocks.
While many attendees are specialists in anesthesiology or pain management, attendees this year came from nearly 20 different specialties, with sizable contingents from rehabilitation medicine, internal medicine and family practice. The course is designated for CME credit for physicians and CE credit for nurses.
“Plan to attend the 2014 Pain Management Symposium to learn about the latest advances in pain medicine and how healthcare reform is changing our practices,” advises Dr. Rosenquist.
For details and registration information on the 2014 symposium, email cmeregistration@ccf.org or visit ccfcme.org/pain14 later this year.