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A RANDOMIZED CONTROLLED CLINICAL TRIAL EVALUATING REDUCED PAIN AND EFFICIENCY OF A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WITH LUMBAR STENOSIS By BRIAN FRANK Bachelor of Arts/Science in Biology University of Florida Gain esville, FL 2011 Biology Honors Coordinator: Dr. R. Elaine Turner CALS Honors Director: Dr. Allen Wysocki Submitted to the Faculty of the College of Agricultural and Life Sciences at the University of Florida in partial fulfillment of the requirements for graduation with honors Contact: email@example.com
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 1 ABSTRACT The purpose of this study was to evaluate if lumbar angulation load reduction from a custom rolling walker can improve walking performance in patients with lumbar spinal stenosis. A cross sectional study with two different treadmill conditions was conducted on fifteen chronic lumbar stenosis patients from the Veterans Affairs Medical Center in Miami, Florida. Participants completed two treadmill walks in randomized order; one walk was unaided and the other walk used the Oliver Static Measuring Apparatus (OSMA), a custom angle load reduction rolling walker. During the OSMA then walked until they reached a severe pain level or the point which the participant would normally stop walking. We measured the time it took to initiate first symptoms (IFS) and total walking time (TWT). In addition, we measured baseline pain with the Numeri c Rating Scale (NRS), fatigue with the Fatigue Severity Scale (FSS), and disability severity with the Oswestry Disability Index (ODI). The OSMA walk showed a significantly greater IFS and TWT. Also, participants who reported higher NRS, FSS, and ODI scores showed significantly lower walking abilities. Finally, the lumbar angle measurements were consistent within the sample. We concluded that patients with lumbar stenosis have reduced walking abilities due to pain and fatigue. The OSMA device was shown to be effective in enhancing walking time and delaying the onset of pain. INTRODUCTION Patients with lumbar spinal stenosis (LSS) are most often at least 50 years of age with prolonged histories of chronic low back pain that radiates to the lower extremity (M iyamoto, 2008). The symptoms, which are posture dependent, are worsened with extension of the lumbar spine or with weight bearing and decreased with flexion or non weight bearing (Miyamoto, 2008). This postural and load dependent nature of lumbar spinal st enosis has important implications regarding the appropriate endurance exercises to be prescribed and tolerated ( Larequi Lauber, 1997 ). A comprehensive rehabilitation program emphasizing endurance exercises may reduce the inactivity that exacerbates symptom s. Axial loading (walking) and spinal extension (erect) both decrease the diameter of the central spinal canal and may cause nerve compression and lower extremity symptoms (Long, 1996). Therefore, with lumbar flexion combined with spinal unloading there is less compression of the joints together with an increase in the space available within the spinal canal. Surgical treatments that reduce the compression in the spine continue to be a popular treatment over the use of non surgical treatments. But, results from surgical treatments in LSS patients have been ambiguous. On the other hand, studies have shown that more than half of LSS patients who participated in nonoperative treatment demonstrated no barriers to activities of daily living and reported improvem ent of symptoms at follow up ( Miyamoto, 2008 & Simotas, 2000 ). Larequi Lauber et al, found that 38% of the LSS patients examined, surgical intervention was inappropriate due to the little consideration conservative treatment could have provided. Sinikalli o et al, studied the pain and happiness in 102 LSS patients, two years after surgery, and found that 18 percent reported more pain and more severe symptoms. However, patients with severe
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 2 spinal stenosis who underwent surgical treatment demonstrated better surgical outcomes ( Jonsson 1997 & Atlas, 1996). Therefore, patients with chronic mild or moderate LSS may be the best candidates for non surgical treatments. Oguz et al, studied 80 patients with LSS on a treadmill using a decline or incline adjustment i n position as well as an unloading station and loading vests set at a fixed walking speed of 1.2km/h. The examination was stopped after 20 min or at the onset of severe symptoms defined as the level of discomfort that would make the patients stop walking in usual life situations. The initiation time of first symptoms (ITS) or time until longer when unloaded using a 20% reduction of body weight compared to no reduction. Fritz et al used a harness to support and unload pressure in a treadmill test to assess walking performance. She found decreases in disability/back pain and increases in walking ability after six weeks of using this spinal unloading harness in lumbar sten osis patients (Fritz, 1997). In another study, Fritz measured ITS, TWT, and recovery time after a patient walked on different leveled surfaces (Fritz, 1997). Walking on an inclined treadmill has been shown to increase spinal flexion (Deen, 1998). She fou nd that inclined walking surfaces decreased the onset of pain symptoms and increased walking ability (Fritz, 1997). Many studies have shown that both spinal unloading and lumbar flexion are effective independent methods in reducing pain in patients with lumbar stenosis. There are no current studies that have combined both of these effects, which have the potential to decrease pain and walking capacity in chronic lumbar stenosis patients. The purpose of this study was to evaluate a combined spinal unloadin g and lumbar flexion treadmill mounted device on walking performance and pain in patients with lumbar spinal stenosis. The study used a lumbar angulation load reduction rolling walker, the Oliver Static Measuring Apparatus (OSMA) with individualized angle settings mounted on a treadmill. The study is worthwhile to determine if the product is efficient at reducing pain measures. If all results fail to support the hypothesis, the data collected would still show which angle is the best at reducing lumbar pres sure and pain in LSS patients. MATERIALS AND METHODS Setting and Design This cross sectional study involved two random order treadmill conditions with veterans from the Miami Veterans Affairs Hospital. The Miami VA approved the study. Participants Pa rticipants were recruited from outpatient clinics at the Miami VA. To be considered for inclusion in the study, the participants must have lumbar stenosis for 6 months or more (confirmed by MRI or CT scans). In addition, the participant must be able to wal k a minimum of 50 feet unassisted. Participants were excluded from the study if they had a BMI greater than 40, Mini Mental State Examination score of less than 24, Pulmonary/Vascular/Neurological Diseases, cognitive illness, neoplastic conditions, or unde rgone lumbar surgery. Of the 20 patients who were recruited for the study, only 15 met the criteria needed. All of the 15 participants agreed to participate after explanation and signing an informed consent.
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 3 Procedure All participants completed two treadm ill walks during one visit. One treadmill walk used the Oliver Static Measuring Apparatus (OSMA) and the other walk did not. The device is shown in Figure 1. The order was randomized to reduce confounding variables (fatigue and pain). The treadmill was set at a walking speed of 1.2km/h with no inclination (Deen, 2000). The Precor C936i treadmill was used for this experiment. The participants were instructed to walk until their pain was severe, defined as the level of discomfort that a person would stop walk ing in normal situations (Oguz, 2007). After 20 minutes, if the participant was still walking, they were asked to stop. Each participant received a 15 minute break between each treadmill condition for recovery. For the treadmill condition with the OSMA, the experimenter adjusted and Digital angle protractor, adjusted for height to match the 4 th 5 th vertebrae in each patient using a telescoping Quik Lok extension pole, to measure the amount of lumbar spinal Scan System pressure sensors were used to measure forearm peak force and pressure distribution. ___________________________ Figure 1 ___________________________ To determine the reliability of t he self selected spinal angle on the Denali protractor, we had the participant complete a two minute treadmill walk with the OSMA device following completion of both treadmill conditions. This reconfirmed the accuracy of the subjective spinal angle. The co nsistency of the spinal angle is fundamental in assessing if the subjective comfortable angle is an effective and reliable measure. Baseline pain measurements were collected using the Numerical Rating Scale (NRS) prior to the start of each treadmill con dition. During each treadmill condition, NRS ratings were then collected when the participant experienced a pain rating increase of one unit and at the time they completed the treadmill conditions. The Oswestry Disability Index (ODI) and the Fatigue Sever ity Scale (FSS) were used to obtain data to conditions. Measures Walking time was measured by two measures; initiation time of first symptoms (ITS) and total walk ing time (TWT) (Oguz, 2007). ITS is defined as the amount of time the total time a participant walked on the treadmill before they reached the level of discomfort t hat the participant would stop walking in normal situations, or a maximum of 20 minutes. Pain was measured with the Numerical Rating Scale (NRS) using a 1 to 10 rating scale with 1 representing the absence of pain and 10 representing the maximum amount of pain. The Numerical Rating Scale (NRS) has been shown to have good accuracy in assessing pain (Ornetti, 2010).
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 4 Disability severity was measured using the Oswestry Disability Index (ODI). The ODI is one of the most commonly used measures for individuals with low back pain. It has good consistency, a high test condition 2008). Each of 10 items is rated on a 0 to 5 sc ale and a percentage of disability can be calculated by dividing the total score by 50 (the maximum score). A higher percentage is indicative of greater disability. The Fatigue Severity Scale (FSS) is the most frequently used fatigue scale. It has a high 2007). The FSS questionnaire contains 9 statements that rate the severity of fatigue symptoms using a number from 1 to 7, with a possible score range of 7 to 63. Higher scores are indicative of greater fatigue, with scores greater than 36 being clinically significant. Statistical Analysis For all sample size calculations we used a significance level of alpha=. 05 and power= .80. All sample size calculations were computed wit h the software Sample Power 2.0. We also used a conservative medium effect size of .3, which is a best estimate for our sample size of 15. This is necessary for using a paired t test for the variables of interest. The primary independent variable for th e study is the OSMA custom angle load reduction condition vs. the treadmill alone. The primary dependent variables are ITS and TWT. Descriptive statistics including mean and standard deviation were computed for all measures. Pearson correlations were comp uted between ODI and FSS scores with ITS and TWT. The paired t test was used for comparison of ITS, TWT, pain scores and other measures. A level of significance of P<0.05 (2 tail) was the level of significance for this study. RESULTS Participants The pa 39 to 68 with a mean of 58 years. NRS scores ranged from 1 to 7 with a mean of 4.9 2.1, indicating a moderate level of baseline pain. FSS scores ranged from 24 to 63 with an avera ge of 46 12, indicating significant levels of baseline fatigue for the majority of participants in the study. ODI scores ranged from 16% to 80% with an average of 48% 18%, indicating moderate levels of disability. Walking Data A paired t test was used to compare ITS and TWT for the two treadmill conditions. ITS was significant for the OSMA condition, which averaged 757 seconds 419 compared to the unaided condition of 141 seconds 66 (t = 5.5; p < .001), this means that an increase in pain level was delayed significantly by use of the OSMA device. TWT data was similar, as there was significantly greater walking time in the OSMA condition 892 404 compared to the unaided condition 403 295 (t = 5.01; p < .001). Figures 2 and 3 show this data graphica lly.
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 5 ___________________________ Insert Figure 2 About Here ___________________________ ___________________________ Insert Figure 3 About Here ___________________________ To determine the relationship between ITS and TWT and the variable measures for e ach condition, we calculated the correlations between each. TWT for the unaided treadmill condition was significantly associated with the Fatigue Severity Scale (r = .81; p < .001), baseline pain (r = .79; p < .001), and severity of disability (r = .74; p < .01). On the other hand, TWT was only correlated with baseline pain in the OSMA condition (r = .64; p < .05). No significant correlations were found for ITS for either treadmill condition. Table 1 shows the correlations between ITS and TWT and the vari able measures. ________________________ Insert Table 1 About Here ________________________ Flexion Angle The spinal flexion angle measured during the OSMA treadmill condition ranged from 15 to 1.6 degrees from the vertical axis with a mean of 7.3 degree s. A Pearson correlation showed that the angle selected by study participants was highly reliable with r = .96 (p < .001). Spinal flexion angle had non significant correlations with baseline pain (r = .03) or severity of disability (r = .12). However, t he spinal flexion angle was significantly correlated with fatigue (r = .52; p < .05). This suggests that participants who walked at a higher degree of flexion reported higher levels of fatigue. No significant correlations were found between spinal flexio n angle and OSMA condition ITS or TWT. Unloading Force Peak force for the right and left forearms were measured in pounds per square inch during the OSMA condition to see if walking distance was significantly effected by combined spinal unloading and lum bar flexion. No significant correlations were found between unloading force and ITS (r = .16) or TWT (r = .12) for the OSMA treadmill condition. DISCUSSION Findings Position (erect or extension) and axial loading (weight bearing) are the two major fact ors that contribute to narrowing and subsequent discomfort in the vertebral canal in
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 6 lumbar stenosis (Oguz, 2007). In this study, we found in patients with lumbar stenosis that ITS and TWT were increased when using the OSMA, a custom angle load reduction r olling walker mounted on treadmill However, we were unable to fully attribute improvements in ITS or TWT to the unloading (using pressure sensors) or spinal flexion angle (Denali protractor measurements) independently, the two factors hypothesized to be c orrected by the OSMA device. Studies have shown that there is a reduction of the spinal compression while patients are in slight extension (Penning, 1992). Lumbar stenosis patients compensate for symptoms by flexing forward. Pua et al, compared the effect iveness of cycling versus treadmill walking with spinal unloading factors and found no difference between the groups in reduction of disability or pain. In our study, the use of the OSMA device is effective in alleviating pain symptoms, which ultimately l ed to an increase in walking performance and delayed onset of pain. As discussed before, Fritz et al, suggested that the postural nature of the pain is the most important element. The OSMA device addresses this postural nature of pain in lumbar stenosis pa tients as seen in the results: decreased onset of higher levels of pain and increased walking time was confirmed while using the device. Oguz et al, concluded that unloading using a harness support as opposed to treadmill incline provided a longer ITS and TWT. However, in his study, posture was assessed using treadmill inclination changes which may not actually provide lumbar spinal flexion. Participants subjectively stated that the forearm rests directly alleviated pain by means of spinal unloading but no statistical significance was shown. The spinal flexion angle, 7.3 degrees, we found remains unclear to have any statistical research value. Although each individual showed high consistency in their angle, an average variation of 2 degrees, there was no si gnificance when compared to the different measures. Fritz et al, suggested that 10 degrees of inclination was found to be appropriate for patients with lumbar stenosis because of long term physical inactivity. Though this study did not prove or disprove h is hypothesis, it demonstrated that an increase in spinal flexion was correlated with increased fatigue severity. This implies that patients who are more fatigued walk at an increased spinal flexion angle or more specifically, the device prolonged the peri od of fatigue which resulted in an increase in TWT. Lumbar stenosis patients who are experiencing pain symptoms, fatigue, or an increased level of disability have decreased walking capacity. This study also showed that unaided walking performance was asso ciated with fatigue and disability severity. Baseline pain was measured prior to the treadmill walks, suggesting a moderate level of pain for lumbar stenosis patients. Our results suggest that baseline pain scores were associated with TWT in both treadmill conditions. The main difference is that the baseline pain scores had a stronger association in the unaided treadmill condition compared to the OSMA condition. This suggests that the OSMA device may have had a role in mitigating symptoms in the baseline pa in scores. Significance There are many related treatments for patients with lumbar spinal stenosis to improve function including cycling, body weight supported treadmill walking, aggressive walking to the point of intense pain, muscle stretching, and tra ining. T here are also many
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 7 controversial views regarding surgical vs. non surgical outcomes. One of these views, supported by Goldman et al, explains that a full time 3 day use of a rollator walker might reduce symptoms of lumbar stenosis, as well as incre ase quality of life and decrease costs. The OSMA device used in this study represents a prototype of a conservative non surgical treatment option that appears to be safe and effective in increasing walking performance, prolonging the onset of pain when wak ing, and increase motivation to stay in shape Limitations and Generalizability Spinal unloading peak force was measured by sensors that measured forearm pressure exerted after the first minute of walking. One limitation of the study, and possibly the rea son that spinal unloading was not found to be correlated with increase in TWT and ITS, relates to the approach this factor was measured. An increase in fatigue or pain might have caused the participant to provide a peak pressure or unloading measurement l ater in the walk, rather than at the beginning (within the first minute). In addition, the results may have been affected by a participants BMI or distribution of pain (left or right). The self selected spinal angle was not found to be correlated with wa lking performance. It is possible that the relationship is not linear (this can explain the low correlation). Instead, future studies should try to find if there is a threshold or analyze this relationship in a different way. The sample size was relativel y small and has moderate generalizability to the entire population. In addition symptoms of lumbar stenosis may be categorized as mild, and the symptoms presented. Di fferent results may have been found if the study sample was restricted to those with severe spinal stenosis, as defined by a specific degree of stenosis. Generally, patients with lumbar stenosis have limited walking capacity due to pain and fatigue. An in crease in lumbar spinal flexion usually accompanies increased fatigue severity. Overall, the OSMA device used in this study was shown to be effective and immediate in significantly increasing walking time and prolonging the onset of pain while walking.
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 8 WORKS CITED 1. Oguz H, Levendoglu F, Ogun TC, Tantug A. Loading is more effective than posture in lumbar spinal stenosis: a study with treadmill equipment. Eur Spine J 2007;(7):913 8. 2. Long DM, BenDebba M, Torgerson WS, Boyd RJ, Dawson EG, Hardy RW, Robertson JT, Sypert GW, Watts C, et al. Persistent back pain and sciatica in the United States: patient characteristics. J Spinal Disord 1996;9(1):40 58. 3. Pua YH, Cai CC, Lim KC. Treadmill walking with body weight support is no more effective than cyc ling when added to an exercise program for lumbar spinal stenosis: a randomized controlled trial. Aust J Physiother 2007;53(2):83 9. 4. Miyamoto H, Sumi M, Uno K, Tadokoro K, Mizuno K. Clinical Outcome of Nonoperative treatment for lumbar spinal stenosis and predictive factors relating to prognosis, in a 5 year minimum follow up. Journal of Spinal Disorders & Techniques 2008;21(8):563 568. 5. Simotas AC, Dorey FJ, Hanraj KK, Cammisa F Jr. Nonoperative treatment for lumbar spinal stenosis. Clinical outcome results and 3 year survivorship analysis. Spine 2000;25:197 204. 6. Larequi Lauber T, Vader JP, Burnand B, Brook RH, Kosecoff J, Sloutskis D, et al. Appropriateness of indicators for surgery of lumbar disc hernia and spinal stenosis. Spine 1997;22:203 209. 7. Sinikalli o S, Aato T, Koivumaa Honkanen H, Airaksinen O, Herno A, Kruger H, Viinamaki H, et al. Life dissatisfaction is associated with a poorer surgery outcome and depression among lumbar spinal stenosis patients: a 2 year prospective study. Spine 2009;18(8):1187 93. 8. Jonsson B, Annertz M, Sjoberg C, Stromqvist B. A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part II: Five year follow up by an independent observer. Spine 1997;22(24):2938 44. 9. Atlas SJ, Deyo RA, Keller RB, Chapin AM Patrick DL, Long JM, Singer DE. The Maine Lumbar Spine Study, Part III. 1 year outcomes of surgical and nonsurgical management of lumbar spinal stenosis. Spine 1996;21(15):1787 94. 10. Fritz JM, Erhard RE, Delitto A, Welch WC, Nowakowski PE. Preliminary re sults of the use of a two stage treadmill test as a clinical diagnostic tool in the differential diagnosis of lumbar spinal stenosis. J Spinal Disord 1997;10(5):410 16. 11. Weiner BK, Walker M, Brower RS, McCulloch JA. Microdecompression for lumbar spinal cana l stenosis. Spine 1999; 24(21):2268 72. 12. Penning L. Functional pathology of lumbar spinal stenosis. Clin Biomech 1992;7:3 17. 13. Scannell JP, McGill SM. Lumbar posture should it, and can it, be modified? A study of passive tissue stiffness and lumbar position during activities of daily living. Phys Ther 2003;83(10):907 917. 14. Goldman S, Barice J, Schneider W, Hennekens C. Lumbar spinal stenosis: Can positional therapy alleviate pain? The Journal of Family Practice 2008;57(4):257 60. 15. Fritz JM, Erhard RE, Vignovic M. A nonsurgical treatment approach for patients with lumbar stenosis. Phys Ther 1997;77(9):962 73. 16. Deen HG, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Use of the exercise treadmill to measure baseline functional status and surgical outco me in patients with severe lumbar spinal stenosis. Spine 1998; 23(2):244 8.
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 9 17. Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc 2000; 75(10):1002 7. 18. Ornetti P, Dougados M, Paternotte S, Logeart I, Gossec L. Validation of a numerical rating scale to assess functional impairment in hip and knee osteoarthritis: comparison with the WOMAC function scale. Ann Rheum Dis 2010;135483. 19. Viani n M. Psychometric properties and clinical usefulness of the Oswestry Disability Index. J Chiropr Med 2008; 7(4):161 3. 20. Armutlu K, Cetisli N, Keser I, Sumbuloglu V, Irem D, Guney Z, Karabudak R et al. The validity and reliability of the Fatigue Severity Sca le in Turkish multiple sclerosis patients. International Journal of Rehabilitation Research 2007;30(1) 81 85.
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 10 FIGURES Figure 1 Oliver Static Measuring Apparatus (OSMA), a custom angle load reduction rollator mounted on treadmill.
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 11 Figure 2. Initiation Time of Symptoms (ITS) per subject for OSMA and Unaided treadmill conditions Note. ITS with OSMA significantly longer compared to ITS unaided (t = 5.5 ; p < .001). Figure 3. Total Walking Time (TWT) per subject for OSMA and Unaided treadmill conditions Note. TWT with OSMA significantly longer compared to TWT unaided (t = 5.01 ; p < .001).
A CLINICAL TRIAL EVALUATING A CUSTOM ANGLE LOAD REDUCTION ROLLATOR ON PATIENTS WIT H LUMBAR STENOSIS Page 12 ITS TWT ITS TWT Baseline Pain .26 .64* .32 .79** Fatigue Severity Score .11 .38 .26 .81*** Oswestry Disability Questionnaire .20 .43 .28 .74** *. Correlation is significant at the 0.05 level **. Correlation is significant at the 0 .01 level ***. Correlation is significan t at the 0 .001 level Table 1 Data on walking performance with the OSMA and Unaided walking trial related to baseline pain, fatigue and disability severity. OSMA Unaided