New Device for Knee OA
This is a recent article form eRheumatology News. The evidence of improvement not only in symptoms but also in Xray changes and delay to joint replacement is welcome news. The device appears to be safe, something I cannot say for most non-steroidal anti-inflammatory drugs (NSAIDs)
Volume 6, Issue 8, Page 22 (August 2007)
Douglas Garland, MD
DR. GARLAND is the director of the division of neurotrauma at Rancho Los Amigos Medical Center in Downey, Calif.
For patients with knee osteoarthritis in whom treatment with analgesics and nonsteroidal anti-inflammatory drugs are insufficient or intolerable, pulsed electrostimulation is a safe, effective, noninvasive option for reducing pain and improving function, and it may even reduce the need for total knee arthroplasty, according to Dr. Douglas Garland, the director of the division of neurotrauma at the Rancho Los Amigos Medical Center in Downey, Calif.
In a randomized, double-blind placebo-controlled trial, Dr. Garland and colleagues evaluated the safety and efficacy of a capacitively coupled, pulsed electrical stimulation (PES) device in 58 outpatients with moderate to severe osteoarthritis of the knee. Study participants were directed to use the active treatment device—a wrap-around knee garment with flexible, embedded electrodes that deliver small electrical currents of 0- to 12-volt output to the affected area—or the placebo device at home for 6–14 hours per day. After 3 months, the active treatment group had greater improvement than controls in a patient global evaluation, patient report of knee pain, and the Western Ontario and McMaster Universities questionnaire. The treatment group had 51% greater improvement in patient global scores, 31% in patient pain, 25% in WOMAC stiffness, 30% in WOMAC function, 20% in WOMAC pain, and 27% in total WOMAC scores. Additionally, substantially more patients in the treatment group had improvement by more than 50% on all measures (Osteoarthritis Cartilage 2007;15:630–7). Dr. Garland was the lead investigator for this study, which was funded by BioniCare Medical Technologies Inc., maker of the device.
Although the precise mechanism by which pulse electrostimulation acts on the human knee is unknown, “three decades of in vitro and animal research provide compelling evidence for a positive local effect on chondrocyte function through gene regulation,” the authors wrote. In this month's column, Dr. Garland discusses the clinical application and promise of pulsed electrostimulation.
Rheumatology News: What are some hypotheses for the improvements associated with PES treatment?
Dr. Garland: There are at least three mechanisms that can be observed clinically when one uses PES. First, in some patients, there is a dramatic reduction in their pain within 1 month after treatment is initiated. This could be the result of a reduction of cartilage degradative enzymes such as interleukin-1 and matrix metalloproteinases and consequent decrease in the inflammatory response, a blockage of the inflammatory response itself, or both. Second, in some patients, radiographs demonstrate an increase in joint space at 3 months. This is most likely secondary to the PES influencing or mimicking the negatively charged aggrecan molecule and attracting positive counter ions, such as sodium. The net effect will be swelling of the articular space and an increase in joint space radiographically. Finally, some patients have late, long-term radiographic increases in their joint space.
We have demonstrated new cartilage by biopsy in one of these patients. This is most likely the result of stimulation of the chondrocytes leading to the upregulation of cell proliferation and matrix synthesis.
RN: Which patients are most likely to benefit from PES therapy?
Dr. Garland: All patients potentially may respond to this treatment modality. One of my most gratifying results occurred in a retired female physician in her 80s who had leukemia and was not a surgical candidate. She was bedridden with constant pain. With bilateral treatment her pain was controlled and she became ambulatory with assistive devices.
RN: Are there any patients for whom the treatment is not appropriate?
Dr. Garland: Treatment is appropriate for all patients. As a surgeon, I recommend surgery [vs. PES] for patients who are more likely to experience future deterioration [at a faster rate] because of medical conditions. A patient's support system may determine whether surgery is an option: PES requires weeks to months of treatment for optimal pain relief, and the device can be bothersome to use daily or nightly for so long. Medicare is now pays for [PES] and most carriers may eventually follow its lead.
RN: Are there objective measures of improvement associated with PES?
Dr. Garland: I have assessed improvement with x-ray and gait analysis.
RN: How does PES compare with other types of electrical stimulation therapy?
Dr. Garland: Percutaneous neuromodulation pain devices control pain; they do not alter the disease. Another option, pulsed electromagnetic stimulation, has not yet been shown to have a stimulatory effect on damaged articular cartilage.
By Diana Mahoney, New England Bureau
OA knee of a woman in her 50s is shown pretreatment (left) and after 9 months of PES (right). Photos courtesy Dr. Douglas Garland
Volume 6, Issue 8, Page 22 (August 2007)
Douglas Garland, MD
DR. GARLAND is the director of the division of neurotrauma at Rancho Los Amigos Medical Center in Downey, Calif.
For patients with knee osteoarthritis in whom treatment with analgesics and nonsteroidal anti-inflammatory drugs are insufficient or intolerable, pulsed electrostimulation is a safe, effective, noninvasive option for reducing pain and improving function, and it may even reduce the need for total knee arthroplasty, according to Dr. Douglas Garland, the director of the division of neurotrauma at the Rancho Los Amigos Medical Center in Downey, Calif.
In a randomized, double-blind placebo-controlled trial, Dr. Garland and colleagues evaluated the safety and efficacy of a capacitively coupled, pulsed electrical stimulation (PES) device in 58 outpatients with moderate to severe osteoarthritis of the knee. Study participants were directed to use the active treatment device—a wrap-around knee garment with flexible, embedded electrodes that deliver small electrical currents of 0- to 12-volt output to the affected area—or the placebo device at home for 6–14 hours per day. After 3 months, the active treatment group had greater improvement than controls in a patient global evaluation, patient report of knee pain, and the Western Ontario and McMaster Universities questionnaire. The treatment group had 51% greater improvement in patient global scores, 31% in patient pain, 25% in WOMAC stiffness, 30% in WOMAC function, 20% in WOMAC pain, and 27% in total WOMAC scores. Additionally, substantially more patients in the treatment group had improvement by more than 50% on all measures (Osteoarthritis Cartilage 2007;15:630–7). Dr. Garland was the lead investigator for this study, which was funded by BioniCare Medical Technologies Inc., maker of the device.
Although the precise mechanism by which pulse electrostimulation acts on the human knee is unknown, “three decades of in vitro and animal research provide compelling evidence for a positive local effect on chondrocyte function through gene regulation,” the authors wrote. In this month's column, Dr. Garland discusses the clinical application and promise of pulsed electrostimulation.
Rheumatology News: What are some hypotheses for the improvements associated with PES treatment?
Dr. Garland: There are at least three mechanisms that can be observed clinically when one uses PES. First, in some patients, there is a dramatic reduction in their pain within 1 month after treatment is initiated. This could be the result of a reduction of cartilage degradative enzymes such as interleukin-1 and matrix metalloproteinases and consequent decrease in the inflammatory response, a blockage of the inflammatory response itself, or both. Second, in some patients, radiographs demonstrate an increase in joint space at 3 months. This is most likely secondary to the PES influencing or mimicking the negatively charged aggrecan molecule and attracting positive counter ions, such as sodium. The net effect will be swelling of the articular space and an increase in joint space radiographically. Finally, some patients have late, long-term radiographic increases in their joint space.
We have demonstrated new cartilage by biopsy in one of these patients. This is most likely the result of stimulation of the chondrocytes leading to the upregulation of cell proliferation and matrix synthesis.
RN: Which patients are most likely to benefit from PES therapy?
Dr. Garland: All patients potentially may respond to this treatment modality. One of my most gratifying results occurred in a retired female physician in her 80s who had leukemia and was not a surgical candidate. She was bedridden with constant pain. With bilateral treatment her pain was controlled and she became ambulatory with assistive devices.
RN: Are there any patients for whom the treatment is not appropriate?
Dr. Garland: Treatment is appropriate for all patients. As a surgeon, I recommend surgery [vs. PES] for patients who are more likely to experience future deterioration [at a faster rate] because of medical conditions. A patient's support system may determine whether surgery is an option: PES requires weeks to months of treatment for optimal pain relief, and the device can be bothersome to use daily or nightly for so long. Medicare is now pays for [PES] and most carriers may eventually follow its lead.
RN: Are there objective measures of improvement associated with PES?
Dr. Garland: I have assessed improvement with x-ray and gait analysis.
RN: How does PES compare with other types of electrical stimulation therapy?
Dr. Garland: Percutaneous neuromodulation pain devices control pain; they do not alter the disease. Another option, pulsed electromagnetic stimulation, has not yet been shown to have a stimulatory effect on damaged articular cartilage.
By Diana Mahoney, New England Bureau
OA knee of a woman in her 50s is shown pretreatment (left) and after 9 months of PES (right). Photos courtesy Dr. Douglas Garland
posted by Ricardo Pocurull at 10:20 AM
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