Effects of a multimodal intervention on gait and balance of subjects with progressive multiple sclerosis: a prospective longitudinal pilot study.

PURPOSE: To investigate the effects of a multimodal intervention including a modified Paleolithic diet, nutritional supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation and massage on walking performance and balance of subjects with progressive multiple sclerosis (MS). MATERIALS AND METHODS: Twenty subjects with mean (standard deviation) age of 51.7 (6.4) years and Expanded Disability Status Scale score of 6.2 (1) participated in a 12-month study. Assessments were completed at baseline, 3, 6, 9, and 12 months. RESULTS: The entire cohort did not show significant changes in any of the assessments over 12 months except higher speed of walking toward the 10 feet mark during timed up and go (TUG) test at 6 months compared with baseline (mean change 7.9 cm/s [95% confidence interval {CI}]: 0.3, 15.2; p=0.041). Sub-group analysis revealed that 50% subjects (n=10) showed decrease in TUG time from baseline to at least 3 of 4 time-points post-intervention and were considered as responders (TUG-Res), the remaining 10 subjects were considered as nonresponders (TUG-NRes). Over 12 months, TUG-Res showed decreased mean TUG time by 31% (95% CI: -52%, -2%), increased median Berg Balance Scale scores (42 to 47), 30% increase in mean timed 25-foot walk speed (>20% considered clinically significant) and increased speed of walk toward 10 feet mark during TUG by 11.6 cm/s (95% CI: -3.0, 25.9) associated with increases in step lengths and decrease in step duration. TUG-NRes showed deterioration in walking ability over 12 months. Comparison of TUG-Res and TUG-NRes showed no significant differences in adherence to intervention but better stride duration and longer step length at baseline for TUG-Res than for TUG-NRes (p<0.05). CONCLUSION: A multimodal lifestyle intervention may improve walking performance and balance in subjects with progressive MS who have mild-to-moderate gait impairment, whereas subjects with severe gait impairments may not respond to this intervention. Future trials should assess effects of this intervention in subjects with MS during early stages of the disease.

The cost-effectiveness of surgery for trigeminal neuralgia in surgically naïve patients: a retrospective study.

OBJECTIVE: For 75% of patients with trigeminal neuralgia (TN), the pain can be controlled with medication. For those who fail medication therapy, surgical options include microvascular decompression (MVD), percutaneous radiofrequency rhizotomy (RFR), and stereotactic radiosurgery (SRS). Few studies have explored the relative cost-effectiveness of these interventions, particularly in surgically naïve patients. METHODS: A retrospective chart review performed between January 2003 and January 2013 identified a total of 89 patients who underwent surgical treatment for TN (MVD=27, RFR=23, SRS=39). Outcome measures included facial pain (excellent=no pain, no medications; good=no pain, medications required; fair=>50% decrease in pain; and poor=<50% decrease in pain/secondary surgery), numbness, cost, and the need for a subsequent procedure. RESULTS: The average age of patients for each procedure was MVD=53.9±16, RFR=76.2±16, and SRS=74.5±12 (p<0.001 MVD vs. other modalities). Total charges for the procedures (US dollars) were MVD=50,100±9600, RFR=4700±2200, and SRS=39,300±6000 (p<0.001). Actual collections varied by insurance. Percentages of postoperative facial numbness were MVD=11%, RFR=52%, and SRS=28% (p<0.01). At two years, the rates of recurrence requiring a second procedure were MVD=22%, RFR=74%, and SRS=31% (p<0.01). Average times to secondary procedure in months were MVD=26±29, RFR=59±76, and SRS=35±25. Mean quality adjusted pain-free years were MVD=1.58, RFR=2.28, and SRS=0.99. Cost-effectiveness calculations in US dollars showed MVD=31,800, RFR=2100, and SRS=39,600 (p<0.001). CONCLUSION: There are significant cost differences among the three most common surgical procedures for TN. MVD was the most expensive procedure, was more likely to be performed on younger patients, had the lowest rate of facial numbness, and had the lowest rate of recurrence requiring a secondary procedure. SRS was slightly less costly, more likely to be performed on an older population, and had a rate of recurrence similar to MVD. RFR was the least expensive procedure, provided immediate relief, but was associated with the highest rates of facial numbness and recurrence. Based on cost-effectiveness, considering both cost and outcome, RFR was the most cost-effective, followed by MVD, and finally SRS.

Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study.

BACKGROUND: Fatigue is a disabling symptom of multiple sclerosis (MS) and reduces quality of life. The aim of this study was to investigate the effects of a multimodal intervention, including a modified Paleolithic diet, nutritional supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, and stress management on perceived fatigue and quality of life of persons with progressive MS. METHODS: Twenty subjects with progressive MS and average Expanded Disability Status Scale (EDSS) score of 6.2 (range: 3.5-8.0) participated in the 12-month phase of the study. Assessments were completed at baseline and at 3 months, 6 months, 9 months, and 12 months. Safety analyses were based on monthly side effects questionnaires and blood analyses at 1 month, 3 months, 6 months, 9 months, and 12 months. RESULTS: Subjects showed good adherence (assessed from subjects' daily logs) with this intervention and did not report any serious side effects. Fatigue Severity Scale (FSS) and Performance Scales-fatigue subscale scores decreased in 12 months (P<0.0005). Average FSS scores of eleven subjects showed clinically significant reduction (more than two points, high response) at 3 months, and this improvement was sustained until 12 months. Remaining subjects (n=9, low responders) either showed inconsistent or less than one point decrease in average FSS scores in the 12 months. Energy and general health scores of RAND 36-item Health Survey (Short Form-36) increased during the study (P<0.05). Decrease in FSS scores during the 12 months was associated with shorter disease duration (r=0.511, P=0.011), and lower baseline Patient Determined Disease Steps score (r s=0.563, P=0.005) and EDSS scores (r s=0.501, P=0.012). Compared to low responders, high responders had lower level of physical disability (P< 0.05) and lower intake of gluten, dairy products, and eggs (P=0.036) at baseline. High responders undertook longer duration of massage and stretches per muscle (P<0.05) in 12 months. CONCLUSION: A multimodal intervention may reduce fatigue and improve quality of life of subjects with progressive MS. Larger randomized controlled trials with blinded raters are needed to prove efficacy of this intervention on MS-related fatigue.

A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.

BACKGROUND: Multiple sclerosis is an autoimmune disease influenced by environmental factors. OBJECTIVES: The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. DESIGN/SETTING: This was a single-arm, open-label intervention study in an outpatient setting. INTERVENTIONS: A multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. OUTCOME MEASURES: Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12. RESULTS: Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. CONCLUSIONS: In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.