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A comprehensive study of patients with surgically treated lumbar spinal stenosis with neurogenic claudication.

BACKGROUND: The relationship between objective measurements and subjective symptoms of patients with spinal stenosis and the degree of narrowing of the spinal canal is not clear. The purpose of this study was to evaluate patients undergoing surgery for lumbar spinal stenosis and intermittent neurogenic claudication with functional testing, quantitative imaging, and patient self-assessment. METHODS: Sixty-two patients with lumbar spinal stenosis and neurogenic claudication were prospectively enrolled in the study. All underwent preoperative magnetic resonance imaging and/or computed tomography myelography, and all were treated with decompressive surgery and were followed for a minimum of two years. The evaluation included treadmill and bicycle exercise tests as well as patient self-assessment with use of the Oswestry Disability Index and a visual analog pain scale preoperatively and postoperatively. RESULTS: Preoperatively fifty-eight (94%) of the patients had a positive result (provocation of symptoms) on the treadmill test and twenty-seven (44%) had a positive result on the bicycle test, whereas postoperatively six and twelve, respectively, had positive results. The mean preoperative scores on the Oswestry Disability Index and visual analog pain scale were 58.4 and 7.1, respectively. Postoperatively, these scores decreased to 21.1 and 2.3, respectively, and both decreases were significant (p < 0.05). Forty-seven (76%) of the patients were seen to have central stenosis on the preoperative imaging studies; forty-one of them had a cross-sectional area of the dural tube of <100 mm (2) at at least one level and twelve had a cross-sectional area of <100 mm (2) at at least two levels. CONCLUSIONS: A positive treadmill test was consistent with a diagnosis of spinal stenosis and neurogenic claudication in >90% of the patients preoperatively. Following surgical decompression of the lumbar spinal stenosis, more functional improvement was demonstrated by the treadmill test than by the bicycle test. The scores on the Oswestry Disability Index and visual analog pain scale also improved postoperatively. The severity of central canal narrowing at a single level does not appear to limit the postoperative improvement in either functional ability or patient self-assessment. Patients with multilevel central stenosis were, on the average, older and walked a shorter distance preoperatively and postoperatively, although the improvement in their postoperative self-assessment scores was similar to that of patients with single-level stenosis.

Aged↗

Treatment of intermittent claudication with mesoglycan--a placebo-controlled, double-blind study.

OBJECTIVE: To assess the effect of treatment with mesoglycan, a sulphated polysaccharide compound, on the walking capacity of patients with stage II peripheral arterial disease. METHODS: Non-diabetic outpatients with intermittent claudication, duplex ultrasound evidence of peripheral atherosclerosis, ankle/arm index <0.80, systolic ankle pressure >50 mmHg, and absolute walking distance (AWD) between 100 and 300 m (standardised treadmill test) were eligible. After a 5-week run-in on single-blind placebo, patients were randomised to double-blind treatment with mesoglycan, 30 mg/day intramuscularly for 3 weeks followed by 100 mg/day orally for 20 weeks, or matching placebo. All patients received low-dose aspirin and lifestyle instructions. Clinical response was defined as an AWD increase at Week 23 >50% over baseline. Health-related quality of life and ischaemic events were assessed as secondary efficacy variables. RESULTS: 242 patients were randomised and 237 were assessed for clinical response. Patients achieving clinical response were 59/118 with mesoglycan (50.0%) and 31/119 with placebo (26.1%; p <0.001). Geometric mean AWD increased from 192 to 298 m with mesoglycan, and from 192 to 238 m with placebo (p <0.001). Pain-free walking distance showed a non-significant increase with mesoglycan (p = 0.057). Changes in quality of life scores were in favour of mesoglycan. The rate of ischaemic events was 1/120 on mesoglycan and 6/122 on placebo (p = 0.053). The rate of non-ischaemic adverse events leading to treatment discontinuation was 7/120 and 4/122, respectively. CONCLUSION: Treatment with mesoglycan improves the walking capacity of patients with intermittent claudication, and might confer additional antithrombotic protection over that of aspirin.

Aged↗

Calf blood flow in intermittent claudication.

Calf blood flow was correlated with severity of symptoms in 24 patients with intermittent claudication. Calf blood flow was measured (Whitney strain gauge) at three levels of demand--at rest, after exercise ("open"), and after exercise with total vascular occlusion by a tourniquet about the thigh ("closed"). The results showed significant correlation between the patients' reported capacity to walk and measured exercise tolerance on an ergometer (P less than or equal to .01). The coefficients of correlation between exercise tolerance and calf blood flow (resting, postopen or postclosed exercise) or the vascular reserve (difference between postopen and postclosed exercise hyperemia) were not significant. It is concluded that capacity for walking in cases of intermittent claudication is not a reliable index of the calf blood flow. The relationship between these factors would be clearer if the patients pain threshold and calf tissue metabolic activity were known also.

Adult↗

Dependent rubor as a predictor of limb risk in patients with claudication.

We followed up 133 patients with claudication to determine the prognostic value of dependent rubor. Life tables analysis was used, with a threatened limb as the endpoint. A threatened limb was defined as the development of ischemic rest pain, skin ulceration, or gangrene. At four years, the rubor group had a limb-threat incidence of 25%, compared with only 9% in the nonrubor group. While not indicative of imminent limb loss, the presence of dependent rubor defines patients whose limb risk is greater than in those with claudication alone.

Adult↗

Exercise for intermittent claudication.

BACKGROUND: Exercise is an inexpensive, low risk option compared with other more invasive therapies for leg pain on walking (intermittent claudication). OBJECTIVES: The objective of this review was to determine the effects of exercise for leg pain. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register, Embase, reference lists of relevant articles, and contacted principal investigators of trials. SELECTION CRITERIA: Randomised trials of exercise regimens in patients with leg pain on walking (intermittent claudication). DATA COLLECTION AND ANALYSIS: At least two reviewers extracted and assessed data trial quality independently. The reviewers contacted investigators to obtain information or data needed for the review that could not be found in published reports. MAIN RESULTS: Fifteen trials were identified that met the inclusion criteria, but five were subsequently excluded because of poor quality. The remaining ten trials involved a total of almost 250 male and female patients with stable leg pain. The follow-up ranged from 12 weeks to 15 months. There was also some variation in the exercise regimens used, although all recommended at least two weekly sessions of, mostly, supervised exercise. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was generally good, though the trials were all small (20-49 patients). Exercise therapy significantly improved maximal walking time (minutes) (weighted mean difference 6.51, 95% confidence interval 4.36 to 8.66, fixed effect model [FE]), with an overall improvement in walking ability of approximately 150% (range 74% to 230%). Exercise produced significant improvements in walking time compared with both angioplasty at six months (weighted mean difference 3.30, 95% confidence interval 2.21 to 4.39, FE) and antiplatelet therapy (weighted mean difference 1.06, 95% confidence interval 0.15 to 1.97, FE), and did not differ significantly from surgical treatment. In one small trial, exercise was less effective than pentoxifylline (weighted mean difference -0.45, 95% confidence interval -0.66 to -0.24, FE). REVIEWER'S CONCLUSIONS: Exercise is of significant benefit to patients with leg pain.

Exercise Therapy↗

The mechanism of calf claudication: studies of simultaneous clearance of 99Tcm from the calf and thigh.

Simultaneous clearance of 99Tcm from the gastrocnemius and quadriceps muscles has been studied in 74 limbs of 62 patients with claudication and in 20 normal limbs of 15 volunteers. The local decay curve for 10 min at rest and for 20 min after a 3-min treadmill walk at 4.5 km/h was recorded. The changes in blood flow which occurred after exercise were characteristic of the arteriographic lesions and they explain the haemodynamics of claudication.

Humans↗

Aorto-iliac reconstructions for intermittent claudication.

Over a 12-year period, 290 aortofemoral reconstructions were performed for intermittent claudication involving 449 legs in 262 patients. The accumulative patency rate in surviving patients was 79 per cent at 5 years. The patency rate was significantly better in patients who stopped smoking after operation, and in men compared with women. Dacron grafts were significantly more successful than endarterectomy in men. If there was no associated superficial femoral artery occlusion, endarterectomy and Dacron bypass grafts were equally successful, but Dacron bypass grafts were significantly superior to endarterectomy if the superficial femoral artery was severely stenosed or occluded. The success rates for improving the patients' intermittent claudication were 90 per cent at 3 months and 72 per cent at 3 years. The success rate at 3 years was 80 per cent if the superficial femoral artery was patent but only 62 per cent if the superficial femoral artery was severely stenosed or occluded. Mortality and morbidity rates fell markedly in the last 6 years of the study.

Aorta↗

The measured effect of stopping smoking on intermittent claudication.

One hundred and twenty-four limbs in patients suffering from intermittent claudication were studied over 10 months. Changes in ankle pressure and treadmill exercise tolerance over the period were compared between two groups, one of patients who continued to smoke (group 1) and the other of those who gave up (group 2). Resting ankle systolic pressure fell in smokers' limbs by a mean of 10.2 mmHg (t = 3.56, P less than 0.001), and rose in those patients who stopped smoking by a mean 8.7 mmHg (P = n.s.). Ankle pressures after exercise and maximum treadmill walking distance did not change in smokers but significantly improved in past smokers. Stopping cigarette smoking increased the chance of improvement in ankle pressure and exercise tolerance in intermittent claudication.

Ankle↗

A reliable and readily available method of measuring limb blood flow in intermittent claudication.

To evaluate isotope limb blood flow measurement in intermittent claudication we have assessed 58 non-diabetic patients comparing our new method with treadmill testing and Doppler assessment. Limb blood flow was applicable to all 58 patients; 25 patients were unable to walk on a treadmill and of the 33 who could 12 failed to walk for one minute, making a standard one minute exercise test inappropriate. In those patients who could perform exercise tests there was a significant correlation between maximum walking distance and limb blood flow (r = 0.35, P = 0.02). Resting, post-exercise and post-hyperaemic ankle-brachial systolic pressure indices bore no relationship to the maximum walking distance. Isotope limb blood flow measurement is reproducible (r = 0.97), can be applied to those patients who cannot walk on a treadmill and provides information about both legs. It correlated significantly with all the other tests and can be recommended for the minimally invasive assessment of intermittent claudication.

Adult↗

Duplex ultrasonography and pulse-generated run-off in selecting claudicants for femoropopliteal angioplasty.

Non-invasive assessment of lower limb vasculature may avoid unnecessary angiography in claudicants. Colour duplex ultrasonography of the femoral and popliteal arteries was performed to assess patency and the presence of any stenoses, and pulse-generated run-off (PGR) was used to assess the distal vasculature. In 65 legs colour duplex scanning was successful, compared with angiography, in identifying the site and type of disease in the femoropopliteal segment and 23 lesions were correctly identified as suitable for angioplasty. More patent distal vessels were demonstrated by PGR than by angiography; no vessels patent on angiography were missed by PGR. The estimated cost of diagnostic angiography was 330 pounds per test compared with 52 pounds for non-invasive assessment. By using duplex examination as a screening test, a potential saving of 8062 pounds could have been made in this series. Duplex ultrasonography offers a non-invasive and cost-effective alternative to diagnostic angiography for clinically suspected infrainguinal arterial disease presenting as claudication. PGR was not of clinical value in assessing suitability for angioplasty.

Aged↗

Xanthine oxidase in critically ischaemic and claudicant limbs: profile of activity during early reperfusion.

Xanthine oxidase activity in blood from the ipsilateral femoral vein, and the relationship between xanthine oxidase production and the products of lipid peroxidation, were studied before operation and for 60 min following release of clamps after successful revascularization in two groups of patients with claudication or critical ischaemia. Before revascularization, detectable levels of xanthine oxidase were found only in patients with critical ischaemia. Clamping during bypass surgery led to release of xanthine oxidase in claudicants, but this activity reduced after 60 min. There was no evidence of lipid peroxidation during this time. Xanthine oxidase activity in brachial vein blood was higher than in femoral vein blood in patients with critical ischaemia before revascularization.

Adult↗

Fibrinolytic risk factor clustering and insulin resistance in healthy male relatives of men with intermittent claudication.

BACKGROUND: Raised fibrinolytic factors predict cardiovascular risk in healthy subjects. The aim of this study was to measure fibrinolytic factors and insulin resistance in healthy male first-degree relatives of men with intermittent claudication younger than 65 years. METHODS: The study compared 165 healthy first-degree relatives with 165 age-, sex- and race-matched control subjects free from a personal or family history of premature cardiovascular disease. Primary outcome measures were plasminogen activator inhibitor 1 (PAI-1), tissue plasminogen activator (tPA) and D-dimer levels. Insulin resistance was estimated by Homeostasis Model Assessment. Clinical and biochemical risk factors were measured and subjects genotyped for the PAI-1 4G/5G polymorphism. RESULTS: First-degree relatives had significantly higher mean PAI-1 (10.23 versus 7.85 ng/ml; P = 0.024), tPA (9.98 versus 8.29 ng/ml; P < 0.001) and D-dimer levels (56.6 versus 46.1 ng/ml; P = 0.004). They also had significantly higher insulin resistance (1.85 versus 1.53; P < 0.001) and clustered multiple atherogenic risk factors. On multivariate analysis the association between both tPA and D-dimer levels and relative status was independent of other variables. CONCLUSION: Raised levels of PAI-1, tPA, D-dimer and estimated insulin resistance were present in the healthy male first-degree relatives of men with intermittent claudication. These data support the hypothesis of fibrinolytic risk factor clustering in this high-risk population.

Cardiovascular Diseases↗

Another look at the pentoxifylline efficacy data for intermittent claudication.

Porter et al have reported that pentoxifylline shows statistically significant superiority over placebo in a seven-center, double-blind, parallel group, randomized trial of outpatients with intermittent claudication secondary to chronic occlusive arterial disease. The objective of this report is convey results of the intention-to-treat population, paying careful attention to relevant methodologic issues relating to the analysis of clinical trials. At the same time, a new measure of clinical efficacy, minimum distance walked, is proposed. The rationale for this measure is discussed and results are compared with those for walking distances at each visit. The reanalysis of the Porter et al data by "intention to treat" and by use of the minimum-distance-walked measure confirms the published findings of efficacy of pentoxifylline for treatment of intermittent claudication.

Aged↗

Pentoxifylline: a new drug for the treatment of intermittent claudication. Mechanism of action, pharmacokinetics, clinical efficacy and adverse effects.

During the past decade, the effectiveness of peripheral vasodilator drugs in the treatment of chronic occlusive arterial disease has been questioned. Pentoxifylline is a hemorheologic agent with primary actions that include increasing erythrocyte flexibility, reducing blood viscosity and increasing microcirculatory flow and tissue perfusion. The result is improved supply of oxygen to ischemic muscles of the limbs. In several double-blind studies, pentoxifylline increased walking distance of patients with intermittent claudication in comparison to placebo or vasodilators. Like other methylxanthines, pentoxifylline is well absorbed in the gastrointestinal tract, almost completely metabolized in the body and excreted in the urine. The most significant difference in its pharmacokinetics is that, unlike other methylxanthines, it is bound to the erythrocytic membrane where it is initially metabolized. Although pentoxifylline has been shown to be effective in the treatment of intermittent claudication, additional research is needed to determine its use as adjunctive therapy in patients with concurrent coronary or cerebrovascular disease.

Adult↗

Dynamic F waves in neurogenic claudication.

Serial F waves were elicited before and after ambulation in 2 patients with neurogenic claudication. In both patients dynamic changes in F wave parameters consisting of either unelicitability or increased latencies occurred postexercise. The time course of these changes and their subsequent rapid reversibility over 15 minutes suggest ischemic-induced conduction block and slowing in proximal motor axons. These physiological changes may account for some of the dynamic neurological symptoms of this disorder. Moreover, F wave exercise testing may provide corroborative information for the diagnosis of neurogenic claudication.

Blood Circulation↗

Effect of ketanserin on macrocirculatory and microcirculatory blood flow in patients with intermittent claudication. A prospective randomized study.

The effect of ketanserin on macrocirculatory and microcirculatory blood flow was investigated in a placebo-controlled, double-blind trial in 11 patients suffering from intermittent claudication using Doppler velocimetry and intravital skin capillary microscopy, respectively. After 1 year of treatment no significant change was observed either in the ketanserin or the placebo group. It appears that ketanserin has no significant effect on macrocirculatory blood flow and microcirculatory nutritional skin blood flow in patients with intermittent claudication.

Aged↗

Intermittent claudication. The effect of physical training on walking tolerance and venous lactate concentration.

Twenty-one patients with intermittent claudication underwent a physical exercise program lasting 8 weeks. The patients were classified on the basis of maximal walking tolerance (MWT) and diagnosis at the initial examination. Seven of the patients had a MWT less than 1,000 m and no symptoms of chronic obstructive airways disease (COAD) or angina (group A), seven had a MWT less than 1,000 m plus angina and/or COAD (group B) and seven had an unlimited (greater than 1,250 m) MWT (group C). At the completion of the training program all three groups showed a significant improvement in walking distance to pain and stress test capacity. During the post-training walking tolerance test, the venous lactate concentrations in group A were lower after 2 min and 4 min of exercise, and at exhaustion (P less than 0.05). Group A patients showed a significant correlation between an increase in MWT after training and a decrease in maximum lactate concentration measured during walking. Although the patients in group B had a significant increase in MWT, blood lactate concentrations in this group were not always decreased by physical training. Group C lactate concentrations were lower after 8 min, 15 min, and 30 min of walking (P less than 0.05). It is concluded that a physical training program increases walking tolerance in different categories of claudicants, and possible mechanisms for the improvement are discussed.

Aged↗

Thermal biofeedback in the treatment of intermittent claudication in diabetes: a case study.

The objective of the present case study was to examine the therapeutic effects of thermal biofeedback-assisted autogenic training on a patient with non-insulin-dependent diabetes mellitus (NIDDM), vascular disease, and symptoms of intermittent claudication. The patient received thermal biofeedback from the hand for five sessions, then from the foot for 16 sessions, while hand and foot skin temperature were monitored simultaneously. In addition, the patient was instructed in autogenic training and practiced daily at home. Follow-up measurements were taken at 12 and 48 months. Within-session foot temperature rose specifically in response to foot temperature biofeedback and starting foot temperature rose between sessions. Posttreatment blood pressure was reduced to a normal level. Attacks of intermittent claudication were reduced to zero after 12 sessions and walking distance increased by about a mile per day over the course of treatment. It would appear that thermal biofeedback and autogenic training are potentially promising therapies for persons with diabetes and peripheral vascular disease.

Biofeedback, Psychology↗