Studies on spinal cord uses for podiatry cases
1. J Neurol Neurosurg Psychiatry. 1983 Jun;46(6):478-84. Spinal cord stimulation in peripheral vascular disease. Tallis RC, Illis LS, Sedgwick EM, Hardwidge C, Garfield JS.
The results of ten patients with severe, intractable symptoms of arterial disease receiving spinal cord stimulation are reported. Six out of ten patients showed clinical improvement. Three of five patients with severe rest pain obtained complete or very marked relief and one of two patients with moderate rest pain in the legs obtained complete relief. The mean claudication distance in the ten patients increased from 65 to 212 metres during epidural stimulation of the spinal cord. Exercise tolerance as measured on a bicycle ergometer increased by 61%. These changes were associated with small increases in cutaneous and muscle blood flow. In those patients who responded clinically, the improvements seen were maintained as long as spinal cord stimulation was continued. There was no clinical response to transcutaneous (placebo) stimulation and four patients did not respond in any way to spinal cord stimulation. The improvements seen are unlikely to be due to either the natural history of the disease or to a placebo effect. The effect is probably due to antidromic stimulation of the central processes of the first order sensory neurons. It is suggested on the basis of animal studies that this effect may be mediated by release of prostaglandins as well as indirectly via pain relief.
2: J Neurosurg. 1986 Jan;64(1):71-80. Spinal cord stimulation in peripheral arterial disease. A cooperative study. Broseta J, Barberá J, de Vera JA, Barcia-Salorio JL, Garcia-March G, González-Darder J, Rovaina F, Joanes V.
Percutaneous epidural stimulation of the low thoracic spinal cord was carried out in 41 patients with pain from peripheral arterial disease of the lower limbs. Results are reported relating to pain, claudication distance, peripheral blood flow, and trophic lesion changes. Following a trial period of stimulation, 37 patients had stimulators permanently implanted. After a mean poststimulation follow-up period of 25 months, substantial pain relief (75% to 100%) was obtained in 29 cases; claudication distance significantly increased in 15 cases; Doppler ultrasound recordings of lower-limb distal arteries showed a tendency toward normalization of pulse-wave morphology, with increase of amplitude in 12 of the 23 patients studied; a rise in skin temperature was also detected by thermography. Distal arterial blood pressure remained unchanged with stimulation. Ischemic cutaneous trophic lesions of less than 3 sq cm healed, but gangrenous conditions were not benefited. A placebo effect or the natural history of the disease can be excluded as the reason for these improvements. It is concluded that spinal cord stimulation is a valid alternative treatment for moderate peripheral arterial disorders when direct arterial surgery is not possible or has been unsuccessful.
3: Ann Vasc Surg. 1994 Sep;8(5):468-74. Epidural spinal cord stimulation in the treatment of severe peripheral arterial occlusive disease. Horsch S, Claeys L. Department of General and Vascular Surgery, Academic Teaching Hospital, Cologne-Porz, Germany.
Epidural spinal cord stimulation (ESCS) has been suggested to improve microcirculatory blood flow and reduce amputation rates in patients with severe peripheral arterial occlusive disease (PAOD). Pain relief, limb salvage, and skin circulation were studied in 177 patients with ischemic pain caused by nonreconstructible PAOD who were receiving ESCS. Medical or surgical therapy had failed and vascular reconstruction was impossible in all cases. Clinical status was classified as Fontaine's stage III (chronic ischemic rest pain) in 114 patients and Fontaine's stage IV (ischemic pain and ulcers or dry gangrene) in 63 patients. PAOD was essentially due to arteriosclerosis, but 36 patients also had diabetic vascular disease. After a mean follow-up of 35.6 months, significant pain relief (> 75%) with limb salvage was achieved in 110 patients. In 11 patients with limb salvage, pain alleviation was determined to be between 50% and 70%. ESCS was ineffective in reducing pain, leading to major amputation in 56 patients. The cumulative limb salvage rate was 66% at 4 years. The systolic ankle/brachial blood pressure index did not change under stimulation. TcPO2 was assessed on the dorsum of the foot. Clinical improvement was associated with increased TcPO2, with limb salvage improving from 24.2 to 48.1 mm Hg in stage III (p < 0.02) and from 16.4 to 37.2 mm Hg in stage IV (p < 0.03) disease. A TcPO2 increase of more than 50% within the first 3 months after implantation was predictive of success. TcPO2 changes are correlated with the presence of adequate paresthesias in the painful area during the trial period.
4: Br J Neurosurg. 1998 Oct;12(5):402-8. The differential effect of the level of spinal cord stimulation on patients with advanced peripheral vascular disease in the lower limbs. Ghajar AW, Miles JB. Pain Research Institute, Walton Hospital, Liverpool, UK.
Percutaneous spinal cord stimulation (SCS) (Medtronic model 3487A PISCES-Quad lead) was carried out in 10 patients with rest pain from advanced peripheral vascular disease of the lower limb, who were unsuitable for conventional treatment. Trial stimulation ranged from 1-20 weeks and was associated with pain relief in nine of the patients. Claudication distance was improved in six patients. Trophic lesions improved in one patient with small artery disease. Spinal cord stimulation did not reverse the course of acute gangrenous lesions. The distal arterial pressure measured by Doppler Ankle/Brachial Pressure Index, (ABPI), showed no change. The capillary blood flow and skin temperature of both feet, measured, respectively, by Laser Doppler flowmetry and skin thermistor, showed a tendency to decrease when the stimulation was at the higher level, above T10, compared with an increase when the stimulation was at the lower level T12. Transcutaneous oxygen tension monitoring of the symptomatic foot showed an increase in four out of five patients. Pain relief was not dependent on circulatory changes, but it was more significant when the circulatory changes showed an impressive increase in the blood flow. The mechanism of these circulatory changes is probably by modulation of the sympathetic nervous system. Recognition of the optimal sitting of SCS may be critical in the clinical use of this technique, which seems to be a valuable option in the treatment of patients with advanced peripheral vascular disease (PVD).
5: J Diabetes Complications. 1999 Sep-Dec;13(5-6):293-9. Epidural spinal cord electrical stimulation in diabetic critical lower limb ischemia. Petrakis IE, Sciacca V. First Department of General Surgery, Policlinico Umberto I, University of Rome, La Sapienza, Rome, Italy.
Spinal cord stimulation (SCS) has been suggested to improve microcirculatory blood flow to relieve ischemic pain and to reduce amputation rate in patients with peripheral arterial occlusive disease (PAOD). The aim of this study was to evaluate the specific prognostic parameters in the prediction of successful SCS, in diabetic patients, performing a retrospective data analysis. To perform this evaluation, 64 diabetic patients (39 men, 25 women; mean age, 69 years) classified as Fontaine's stage III and IV, with PAOD, were treated with SCS for rest pain and trophic lesions with dry gangrene, after failed conservative or surgical treatment. In clinical controls, pedal transcutaneous oxygen tension (TcPO(2)), ankle/brachial blood pressure index (ABI), and toe pressure Doppler measurements were utilized to select and follow-up the patients. After 58 months of follow-up (range, 20-128 months), pain relief greater than 75% and limb salvage were achieved in 38 diabetic patients. A partial success was obtained in nine patients with pain relief greater than 50% and limb salvage for at least 6 months. The method failed in 17 patients or the device was removed due to technical problems, and the limb was amputated in these patients. TcPO(2) was assessed on the dorsum of the foot. Clinical improvement and SCS success were associated with increase of TcPO(2), before and after implantation. Limb salvage was achieved in the patients who had significant TcPO(2) increase within the 2 weeks of the testing period, independently of the stage of the disease. A TcPO(2) increase of more than 50% in the first 2 months after implantation was predictive of success, and was related to the presence of adequate paresthesias in the painful area during the trial period. TcPO(2) significantly increased after long-term follow-up in all patients with limb salvage (from 22.1 to 43.1 mm Hg in the rest pain patients, from 15.8 to 36.4 mm Hg in those with trophic lesions of less than 3 cm(2), and from 12.1 to 28.1 in those with trophic lesions of greater than 3 cm(2), (p < 0.01). ABI did not changed under stimulation. In diabetic patients with PAOD, the SCS increases the skin blood flow, is associated with significant pain relief, and could be proven an excellent alternative therapy, improving the life quality. Significant TcPO(2) increase within the 2-week test period, is a predictive index of therapy success and should be considered before the final decision in terms of cost effectiveness, before the permanent implantation.
6: Int Surg. 1999 Apr-Jun;84(2):122-8. Transcutaneous oxygen tension (TcPO2) in the testing period of spinal cord stimulation (SCS) in critical limb ischemia of the lower extremities. Petrakis IE, Sciacca V. First Department of General Surgery, Policlinico Umberto I, University of Rome, La Sapienza, Italy.
BACKGROUND: Spinal cord stimulation (SCS) improves microcirculatory blood flow, relieves ischemic pain and reduces amputation rate in patients with severe peripheral arterial occlusive disease. AIM: To evaluate the transcutaneous oxygen tension (TcPO2) measurements as a specific prognostic parameter in the prediction for permanent device implantation in a prospective controlled study in patients with lower limb ischemia. METHODS: 45 patients (35 men, 10 women; mean age 65 years, range: 46-70 years) were submitted to implantation of a spinal cord electrical generator for rest pain, trophic lesions dry gangrene in severe lower limb ischemia, after failed conservative or surgical treatment. The clinical status was classified as Fontaine's stages III and IV and the main pathology was essentially due to atherosclerosis and diabetic vascular disease. Pedal transcutaneous oxygen tension (TcPO2), ankle and toe pressure Doppler measurements were performed before, 2 weeks and 4 weeks after implantation. RESULTS: After 18 months follow-up, pain relief was > 75% and limb salvage was achieved in 26 patients. In 9 patients, a partial success with pain relief > 50% and limb salvage was obtained for at least 6 months. In 10 patients, the method failed, and the patients' limbs were amputated. TcPO2 was assessed on the dorsum of the foot. Clinical improvement and SCS success was associated with an increase of TcPO2, within the first 2 weeks after implantation (temporary period). Limb salvage was achieved in those patients who presented significant TcPO2 increase within the first 2 weeks of the testing period (from 21.6 mmHg to 29.5 mmHg in the patients with rest pain, P = 0.035, from 15.2 mmHg to 21.1 mmHg, P = 0.035 in those with trophic lesions < 3 cm2, and in those with trophic lesions > 3 cm2, from 12.4 mmHg to 17.3 mmHg) independently of the stage of the disease and of the initial TcPO2 value. TcPO2 changes were related to the presence of adequate paresthesias and warmth in the painful area during the trial period. The systolic ankle/brachial blood pressure index did not change under stimulation. CONCLUSIONS: In patients with failed conservative and surgical treatment for severe critical lower limb ischemia, the SCS increases the skin blood flow, is associated with a significant pain relief and could prove an excellent alternative therapy that improves the quality of life. We also demonstrate that TcPO2 increase within a test period of 2 weeks, is a predictive index of SCS therapy success and should be considered in terms of cost effect before the final decision for permanent implantation.
7: J Neurosurg Sci. 1999 Dec;43(4):285-93. Spinal cord stimulation in critical limb ischemia of the lower extremities: our experience. Petrakis IE, Sciacca V. 1st Department of General Surgery, Policlinico Umberto I, University of Rome La Sapienza.
BACKGROUND: Spinal cord stimulation (SCS) improves microcirculatory blood flow, relieves ischemic pain and reduces amputation rate in patients with severe peripheral arterial occlusive disease. Aim: To evaluate the specific prognostic parameters in the prediction of successful SCS and to perform a retrospective data analysis obtained during our patient follow-up. METHODS: 150 patients (97 men, 53 women; mean age: 68 years; range: 46-81) were submitted to implantation of a spinal cord electrical generator for rest pain, and trophic lesions with dry gangrene in severe lower limb ischemia, after failed conservative or surgical treatment. The clinical status was classified as Fontaine's stage III and IV and the main pathology was essentially due to atherosclerosis and diabetic vascular disease. In clinical controls, pedal transcutaneous oxygen tension (TcPO2), ankle and toe pressure Doppler measurements were utilised to select and follow-up the patients. RESULTS: After a mean follow-up of 71 months (range 24-138), pain relief >75% and limb salvage was achieved in 85 patients. In 28 patients was obtained a partial success with pain relief >50% and limb salvage for at least 6 months, while in 37 patients the method failed or for technical problems the device was removed, and the patients were amputated. TcPO2 was assessed on the dorsum of the foot. Clinical improvement and SCS success was associated with the increasing of TcPO2, before and after implantation (temporary period). Limb salvage was achieved in the patients that presented significant TcPO2 changes within the first 2 weeks of the testing period, indifferent from the stage of the disease, and from the initial TcPO2 value. After long-term patient follow-up TcPO2 changes, from 22.6 to 43.1 mm Hg in these with rest pain (p<0.01), from 16.2 to 36.1 mmHg (p<0.02) in those with trophic lesions <3 cm2, and from 12.4 to 28.1 in the patients with trophic lesions >3 cm2. A TcPO2 increase of more than 50% in the first 2 months after implantation was predictive of success, and was related with the presence of adequate paresthesias in the painful area during the trial period. The systolic ankle/brachial blood pressure index did not change under stimulation. CONCLUSIONS: In patients with failed conservative and surgical treatment for severe critical lower limb ischemia, the SCS increases the skin blood flow, is associated with a significant pain relief and could be proven an excellent alternative therapy that improves the quality of life. TcPO2 changes, within a test period of 2 weeks, is a predictive index of therapy success and should be
8: Surg Neurol. 2000 Feb;53(2):182-8; discussion 188-9. Does autonomic neuropathy influence spinal cord stimulation therapy success in diabetic patients with critical lower limb ischemia? Petrakis IE, Sciacca V. 1st Department of General Surgery, Policlinico Umberto I, University of Rome, La Sapienza, Italy.
BACKGROUND: Spinal cord stimulation (SCS) improves microcirculatory blood flow and relieves diabetic neuropathic and ischemic pain, reducing the amputation rate in patients with peripheral arterial occlusive disease (PAOD). The purpose of this study was to evaluate whether the presence of autonomic neuropathy in diabetic patients with PAOD influences the success of SCS therapy. METHODS: Sixty consecutive diabetic patients (15 with early and 13 with definite and/or combined autonomic neuropathy) with an ankle/brachial systolic pressure index (ABI) less than 0.20 +/- 0.08, underwent spinal cord stimulation after failed conservative or surgical treatment. The neuropathic status of the patients was evaluated before implantation and pedal TcpO2 measurements on the dorsum of the foot were performed. RESULTS: Limb salvage and pain relief >75%, evaluated with the visual analogue scale, were achieved in 35 patients, whereas in 12 a partial success with pain relief >50% and limb salvage for at least 6 months were obtained. In 13 patients the method failed and the ischemic limbs were amputated. Among the 28 diabetic patients with autonomic neuropathy the treatment failed or resulted in only partial success in 25, whereas in all 32 patients without neuropathy limb salvage and pain relief >75% were achieved (p < 0.0001). Partial success in 10 patients with early neuropathy and in two with definite was achieved (p = 0.008), whereas in 11 patients with definite neuropathy and in two with early the method failed (p < 0.001). The stage of the neuropathy was inversely related to the success of SCS therapy, independent of the stage of the disease. The method's success was related to the presence of adequate paraesthesias and warm feeling in the painful area with size reduction of the trophic lesions. CONCLUSIONS: Diabetic patients with peripheral arterial occlusive disease presenting with intractable pain may be successfully treated with spinal cord stimulation unless they have associated severe autonomic neuropathy.