Integrative Program May Negate Need for Spinal Stimulator

September 28, 2012 (Phoenix, Arizona) — A multimodal, integrative medicine approach to patients with chronic pain referred for implantation of a spinal cord stimulator shows efficacy in decreasing pain to such an extent that patients could forgo the implantation, according to research presented here at the American Academy of Pain Management (AAPM) 23rd Annual Clinical Meeting.

Spinal cord stimulator implantation, usually provided as a last resort for chronic back pain when all other treatment modalities have failed, is considered successful only if a patient has at least a 50% reduction in pain. In addition, the procedure is not cheap, costing on average about $46,000, whereas an integrative approach of various alternative interventions costs approximately $9600, according to lead author Lance Luria, MD, vice president and medical director of Mercy Health and Wellness and executive director of Mercy Integrative Medicine in Springfield, Missouri.

In the study presented here, Dr. Luria and his colleagues evaluated 31 patients with chronic back pain who had been referred to receive spinal cord stimulator implantation as part of a trial.

The integrative therapy they were offered consisted of various interventions, including manual therapies, mind-body therapies, acupuncture, nutrition counseling, and psychology services.

The average length of treatment was 3.4 months, and at a 12-month follow-up, Dr. Luria and his team found that 29 (89%) of participants had not had a spinal cord stimulator placed.

Although the average initial Visual Analogue Scale (VAS) score for pain was 7.35, the rate had dropped to as low as 1.710 by discharge. The mean (± standard deviation) decrease in VAS pain score among the patients was 5.64 ± 2.26 points (P < .001).

"Given these results, it appears that an integrative medicine intervention may be a useful alternative," the authors write. "These treatments were much lower than the charges for spinal cord stimulator [SCS] implantation and SCS implantation is not without significant medical risk."

Discussing his integrative care model at Mercy Integrative Medicine, Dr. Luria noted that the key to success is that integrative care members work together as a team, which includes physician-led weekly team meetings.

"In the final analysis, I'm the physician, so I call the shots, but the alignment of incentives and key, and all team members are subordinate to an outcome-driven goal," he told Medscape Medical News.

He noted the importance of remembering an 80%/20% rule of thumb, meaning that integrative care may not be the answer for 100% of patients, but 80% can often be helped. Dr. Luria warned, however, that clinicians need to carefully consider the realistic progress patients are making.

His team is a mix of independent contractors, including massage therapists and acupuncturists, as well as staff nutritionists and other specialists. Dr. Luria added that the health system pays for such staff because the investment is rewarded with benefits — and savings.

"The employees are paid by the health system because we save them a lot," he said. "And they don't micromanage us either, because our results are so good they leave us alone."

Time of the Essence

According to orthopedic surgeon Peter Moskovitz, MD, integrative care programs can be highly beneficial, but time can be of the essence in terms of their success.

"There are a number of studies that document that Luria's type of treatment protocol is effective for a significant number of motivated patients," said Dr. Moskovitz, a clinical professor of orthopaedic and neurologic surgery at the George Washington University, Washington, DC.

"Usually such programs screen their patients and some will not enroll at the outset," he pointed out. The inclusion of such patients may have led to different results in the research, he suggested.

"The problem with this study is that it is uncontrolled and when patients qualify for an intervention and then wait, a significant number will decline the intervention," he noted.

Strong leadership is also crucial to the programs' success, Dr. Moskovitz said. "Such programs are highly dependent on the practitioner and Luria is one of the best," he said. "His results will probably be very difficult to replicate by the average practitioner or therapist."

Pain specialist R. Norman Harden, MD, suggested, however, that the average practitioner often fails to even give such integrative approaches a fighting chance.

"Yes, they may have tried a very few integrative/nondrug/noninterventional options, but almost never the standard of care rehabilitation centered programs," said Dr. Harden, director of the Rehabilitation Institute of Chicago's Center for Pain Studies and the Addison Chair in Pain Studies at Northwestern University in Chicago, Illinois.

"Interventionalists usually aren't trained to entertain these effective treatments, rarely know anything about them, can't assess if they have been appropriately performed, and thus inappropriately conclude the pain to be 'intractable'," he said.

Clinicians may feel obliged to turn to spinal cord stimulation when patients have failed to respond to an "extremely limited and naive idea of what constitutes standard of care," Dr. Harden said, adding that "An interdisciplinary approach is hard, labor intensive, time consuming, and not profitable, and practitioners often won't even consider the effective integrative/holistic/interdisciplinary approach."

Patients are instead automatically referred for the far more expensive spinal cord stimulator approach, of which Dr. Harden is not exactly a fan: "I am extremely dismayed by the fact that spinal cord stimulators have been in use for 25 years without definitive studies proving that they work."

"The extant studies are weak and inconclusive, or suggest they do not work at all, yet the FDA [Food and Drug Administration] allows these devices to be implanted without the sort of science required of drugs, for instance."

"The only explanation is the profit margins of continuing to use these experimental devices without a proper risk benefit or cost benefit analysis" he said.

Dr. Luria, Dr. Harden, and Dr. Moskovitz have disclosed no relevant financial relationships.

American Academy of Pain Management (AAPM) 23rd Annual Clinical Meeting. Abstract 36. Presented September 22, 2012.