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Effects of Therapy in Patients Suffering from Chronic Back Pain Treated with Spinal Cord Stimulation
Original Article Effects of Therapy in Patients Suffering from Chronic Back Pain Treated with Spinal Cord Stimulation ---
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From the *Department of Neurosurgery and Peadiatric Neurosurgery, Medical University of Lublin; †Department of Tourism and Recreation, University of Life Science in Lublin; ‡Department of Rehabilitation, Physiotherapy and Balneotherapy, Medical University of Lublin; § Department of Neurosurgery and Peadiatric Neurosurgery, Students Medical Association, Medical University of Lublin, Lublin, Poland. Address correspondence to Anna Mosiewicz, MD, PhD, Department of Neurosurgery and Paediatric Neurosurgery, Medical University of Lublin, Jaczewskiego St. 8, Lublin, Poland. E-mail: mosiewiczanna@ gmail.com Received September 18, 2014; Revised November 28, 2014; Accepted January 29, 2015. 1524-9042/$36.00 Ó 2015 by the American Society for Pain Management Nursing http://dx.doi.org/10.1016/ j.pmn.2015.01.004
_ Anna Mosiewicz, MD, PhD,* Elzbieta Rutkowska, PhD,† ‡ Monika Matacz, MS, Barbara Mosiewicz,§ Robert Kaczmarczyk, MD, PhD,* and Tomasz Trojanowski, MD, PhD*
ABSTRACT:
Pain in the lumbosacral part of the spine in the course of degenerative disease is the most common cause of physical activity limitation in adults. Treatment includes pharmacotherapy, physiotherapy, psychotherapy, health promotion, and sometimes surgery. Surgical treatment is not always successful, and the various clinical and psychosomatic symptoms that result from surgical treatment failure are known as failed back surgery syndrome. For some patients with this condition, spinal cord stimulation can provide relief. The aim of the work was to define subjective and objective spinal cord stimulation effects by assessing chosen disability and physical activity limitation ratios. Pain intensity, level of disability, and presence of neurological symptoms were assessed. The examination was performed twice: before the stimulator implantation and at least 6 months postimplantation. The study was conducted at the Department of Neurosurgery and Paediatric Neurosurgery in Lublin. Thirty-six patients suffering from failed back surgery syndrome were recruited for this study. The Visual Analog Scale, modified Laitinen’s pain questionnaire, and Oswestry Disability Index were used in this work. The study showed that spinal cord stimulation was effective in treating spinal and lower limb pain in 64% of patients, similar to results obtained in other departments. Although back pain and neuropathic pain radiating to the lower limbs decreased, moderate physical activity impairment was still observed according to the Oswestry Disability Index scale. The decrease in neuropathic pain radiating to the lower limbs had the most significant influence on reducing physical activity impairment. Ó 2015 by the American Society for Pain Management Nursing
Pain Management Nursing, Vol -, No - (--), 2015: pp 1-6
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Mosiewicz et al.
BACKGROUND
MATERIALS AND METHODS
Back pain resulting from degeneration of the spine is one of the most frequent conditions affecting adults today. Disorders of the lumbosacral part of the spine are the most common causes of physical activity limitation in adults and one of the main reasons for absences from work (Andersson, 1999; Maniadakis & Gray, 2000). It is estimated that 60%-80% of the adult population suffer from this kind of pain (Hoy, Brooks, Blyth, & Buchbinder, 2010). Cases of reported back pain require careful diagnostic testing, thorough risk factor analysis, and adequate therapy. Treatment for back pain includes pharmacotherapy, physiotherapy, psychotherapy, health promotion, and—if these means turn out to be insufficient (e.g., there are symptoms of neurological disorders or the pain is unbearable)—surgery (Krasucki, 2005). The percentage of patients whose back pain is treated surgically varies across countries, ranging from 0.4% to 2.2% (Andersson, 1999). Surgery will not solve all of a patient’s medical issues; it is still necessary to introduce a secondary prevention program and lifestyle changes (Krasucki, 2005). The outcome of therapy is also influenced by how well the back pain risk factors can be controlled and active cooperation of the patient (Slade & Molloy, 2009). Surgical treatment is associated with a risk of failure. It is estimated that 8% to 25% of operations to relieve back pain do not result in satisfactory outcomes (Rutkowska, 2004; Taylor, Van Buyten, & Buscher, 2005; Wetzel & LaRocca, 1991). These patients require further treatment, often another (and sometimes multiple) surgical intervention. The various clinical and psychosomatic symptoms that result from the failure of surgical treatment are defined as failed back surgery syndrome (FBSS) and post-laminectomy syndrome. Chronic pain, which is the main component of FBSS, limits a patient’s participation in normal life activities and causes serious disability. Spinal cord stimulation (SCS) is, for a small group of these patients (qualification criteria are fulfilled by about 5% of patients), a chance to improve their quality of life (Kumar, Hunter, & Demrtia, 2006).
Thirty-six patients treated with SCS in the Department of Neurosurgery in Lublin from 2008 to 2013 took part in the study. The group consisted of 20 women and 16 men aged 43 to 80 years (mean age 59.61 9.36 years). Patients qualified for SCS after failed surgery on the lumbar part of the spine (from 1 to 8 operations). Pharmacotherapy and physiotherapy were also insufficient in treating chronic pain in the course of degenerative disease. Patients were qualified for stimulator implantation after taking their medical history, a clinical examination, and medical imaging (CT or MRI) examination. Patients with active psychiatric disorders, severe depression, hypochondriac behaviors, and histories of drug and alcohol abuse were excluded from the study. Patients’ state assessments also included clinical examination in order to determine the pain intensity and level of disability caused by FBSS. In this study the following methods were used: Visual Analog Scale (VAS) according to Huskisson (1982)—type and intensity of pain of the lumbar part of the spine as well as neuropathic pain radiating to the lower limbs were assessed, scoring from 0 (no pain) to 10 (unbearable pain) Pain assessment modified scale according to Laitinen (1979) Oswestry questionnaire (Oswestry Disability Index [ODI])—this scale consists of 10 questions concerning pain intensity, self-care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and travelling. The patient was to choose the answer that best reflected his or her situation; point values for each question range from 0 to 5, for a possible maximum score of 50. Point totals were converted to percentages (1 point ¼ 2%). On the basis of this questionnaire, five degrees of life quality impairment are determined: 0%-20%, no disability; 21%-40%, slight disability; 41%-60%, moderate disability; 61%-80%, serious disability, with pain affecting all aspects of life; 81%-100%, complete disability, patient is bedbound (Niskansen, 2002).
All examinations were performed twice: before the implantation and at least 6 months postimplantation.
RESULTS AIM OF THE STUDY The aim of this work is to assess the effectiveness of SCS in subjective (chronic pain treatment) and objective (chosen disability and activity limitations ratios) categories for this particular group of patients. Recognition of these limitations also allows us to better define the aims of functional improvement therapy for physiotherapists as well as for patients.
Patients were treated symptomatically and surgically because of pain and limitations resulting from degenerative disease of the spine. Twenty-three patients had been diagnosed with chronic comorbidities: hypertension (23), diabetes (7), and chronic obstructive pulmonary disease (4). A majority of the group (30 patients [83.3%]) were professionally inactive because of poor health and age. Between 2
3
Effects of Spinal Cord Stimulation
and 17 years had passed since the patients’ last operation. Aside from unsatisfactory surgical treatment, patients had been using the following methods to control their pain: Nonsteroidal anti-inflammatory drugs or painkillers: 36 (100%) Physiotherapy: 31 (86.1%) Massage: 22 (61.1%) Acupuncture: 6 (16.7%) Alternative medicine: 5 (13.9%) Antiepileptics: 1 (2.8%) Antidepressants: 1 (2.8%)
The intensity of spinal pain and the pain radiating to the lower extremities before spinal neurostimulator implantation was considerable, averaging 8 points on the 10-point VAS scale (Table 1). Two patients described their lumbar spine pain intensity as a 10 on the VAS scale, while 9 patients rated their pain at 9. Neuropathic pain of the lower limbs was rated at 10 on the VAS scale by 4 patients and as a 9 by 10 patients. Particular components of the four-point Laitinen scale were similarly high: pain intensity (2.94 0.53), pain frequency (3.5 0.81), painkiller use (2.69 0.53), and physical activity limitation caused by pain (2.47 0.73). Total pain assessment on the Laitinen scale (minimum 0, maximum 16) was 11.61 2.09 points. All patients who qualified for SCS displayed root pain syndrome upon physical examination. Neurological disorders and pain caused physical activity limitation in these patients; according to the pre-implantation ODI, it was assessed as serious (73.5% 5.11%). Treatment with spinal cord neurostimulation was effective in lowering the pain level (Table 1). According to the Laitinen pain scale results, pain intensity decreased after implantation in 35 patients (97.22%), with 1 patient reporting no improvement. On the basis of the responses to the Oswestry questionnaire concerning pain, improvement was reported by 33
patients (91.7%) and deterioration was observed by 3 patients (8.3%). Similar results were obtained in assessments of back pain treatment using the VAS scale. Almost all patients (35 [97.22%]) reported a decrease of pain. One patient did not observe any changes after the implantation. Assessment of pain radiating to the lower limbs on the VAS scale showed slightly worse results: pain reduction was reported by 32 patients (88.89%), 3 patients (8.33%) did not observe any improvement, and 1 patient (2.78%) reported worsening pain. Average intensity of back and lower limb pain decreased in the group as a whole (Table 1). Spinal stimulator implantation improved the average rates of physical activity as assessed with the Oswestry questionnaire (Table 2). In the assessment of physical dysfunction caused by back pain, serious disability (61%-80%) was observed before implantation of spinal stimulator. Six or more months after the implantation, the disability level was lower, but it ranged between moderate and serious disability (Table 2). The effects of SCS therapy on pain reduction were assessed according to the increase of physical activity as rated on the Laitinen scale. Postimplantation, physical activity limitation was 1.23 points lower than the pre-implantation rating. One patient (2.78%) reported that pain did not affect physical activity before and after operation. Twenty-three patients (63.89%) reported improvement after neurostimulation therapy, 11 patients (30.55%) did not observe any changes, and one patient (2.78%) reported deterioration. Assessment with the Laitinen scale led to the conclusion that the number of patients with no or partial physical activity limitations increased after the operation (Table 3). Patients reported impairment in all categories included in the Oswestry questionnaire. In this study, ODI categories concerning physical activity were assessed. The average results in categories concerning physical capacity are presented in Figure 1. Results of clinical examinations were used to define the relationship between decreased pain
TABLE 1. Change in Pain Intensity for Patients (n ¼ 36) Treated with Spinal Cord Stimulation Pain Assessment on the Laitnen Scale
Back Pain on the VAS
Lower Limb Pain on the VAS Scale
Pain Assessment
Before SCS
After SCS
Difference
Before SCS
After SCS
Difference
Before SCS
After SCS
Difference
Average SD
11.61 2.09
5.58 2.93
6.03 3.00
7.67 1.93
4.28 2.20
3.39 2.57
7.61 2.19
4.00 2.75
3.61 3.27
SCS ¼ spinal cord stimulation; SD ¼ standard deviation; VAS ¼ Visual Analog Scale.
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Mosiewicz et al.
TABLE 2. Activity Impairment Ratios in the Oswestry Disability Index (n ¼ 36) Result
Disability in ODI
Category
Before SCS
After SCS
Difference
Mean SD Level of disability
36.75 5.11 73.50% 10.22 (Serious)
30.08 8.40 60.16% 16.80 (Moderate)
6.67 8.36 13.34% (16.72)
ODI ¼ Oswestry Disability Index; SCS ¼ spinal cord stimulation; SD ¼ standard deviation.
level on the VAS scale and Laitinen questionnaire, and physical activity improvement. Statistical analysis with Spearman’s correlation rank coefficient (p < .05 was stated as statistically significant) showed that: Decreased back pain in the VAS scale after implantation moderately lowers the level of disability (R ¼ .51; p ¼ .002) assessed with the Oswestry questionnaire; it also improves travelling (R ¼ .48; p ¼ .005) and walking (R ¼ .43; p ¼ .014) capacities. Decreased neurogenic pain of the lower limbs after SCS application moderately improved levels of self-care (R ¼ .56; p ¼ .0008), walking capacity (R ¼ .56; p ¼ .0006), social life (R ¼ .50; p ¼ .002), quality of travelling (R ¼ .49; p ¼ .0009), and lifting ability (R ¼ .44; p ¼ .01) according to the Laitinen pain questionnaire. There is a statistically significant correlation between a decrease in lower limb pain and level of disability according to the ODI (R ¼ .65; p ¼ .04).
All other attempts at finding statistical correlation did not lead to any significant results.
DISCUSSION Physical capacity is of intrinsic and instrumental value in all aspects of life quality. According to the holistic approach in medicine, physical activity is thought to
TABLE 3. Physical Activity Limitation before and after Spinal Cord Stimulation One the Laitinen Scale Before SCS
After SCS
be an important preventive, diagnostic, and therapeutic factor (Rutkowska, 2004). This is why assessment of physical disability level in chronic diseases is a significant measure of life quality, which supplements clinical examination. Physical and life activity limitation results from chronic and refractory pain and diseases affecting the spine and the spinal cord (Griffin, Harmon, & Kennedy, 2012). These ailments often are followed by psychoreactive syndromes, which significantly lower quality of life (Kawanishi & Greguol, 2013). Since the 1980s, therapy with SCS has been available for patients for whom other treatment modalities (including surgery) have been ineffective (Kumar, Hunter, & Demrtia, 2006). Every year, approximately 15,000 patients worldwide are treated with this method because of neuropathic and ischemic pain (Cameron, 2004). In Europe, approximately 5000 stimulators are implanted because of pain of various origins (Gybels et al., 1998). The aim of this work was to assess the efficacy of treatment with neurostimulation from the patient’s perspective. This part of the study was the supplementation of clinical examination. Therapy effectiveness assessment in clinical categories (reduction of pain and neurological disorders) should be supplemented by assessing improvement of functioning in everyday life. An objective measure of neurostimulation efficacy was determined by comparing the intensity and type of pain reported before the implantation with the pain after SCS
n
%
n
%
No limitation 1 2.78 5 13.89 Partial 2 5.56 16 44.44 Professional activity impairment 12 33.33 9 25.00 Requiring partial help 21 58.33 6 16.67 Requiring complete help 0 0 0 0 Sum 36 100 36 100 SCS ¼ spinal cord stimulation.
4.06
2.44
traveling
3.78
2.25
social life
3.72
2.28
sitting
Physical Activity Limitations
before SCS
standing
3.39
1.86
walking
3.14
2.03
lifting daily activity
1.66
0
1
2
4.13
3.11 2.89
score
3
4
5
FIGURE 1. - Physical activity impairment before and after spinal cord stimulation (SCS) on the Oswestry Disability Index (n ¼ 36).
Effects of Spinal Cord Stimulation
reported at least 6 months postimplantation. (The 6-month delay in reevaluating pain was to prevent the confusion of pain related to the operation with chronic pain). Effective pain therapy should also result in increased levels of activity for the patients. Patients who qualified for the operation suffered from pain of the spine and lower limbs (as rated on the VAS scale) and showed a serious level of disability (based on the results of the ODI) (Tables 1 and 2). Although the results of the treatment varied among individual patients, in most patients (64%) there was decrease of pain observed, which is similar to results obtained in other departments (Cameron, 2004; Davis, 1994; Kumar et al., 2006, 2008). According to the VAS and Laitinen scale, pain was one-third lower in both scales and approximately 14% of patients did not report any physical activity limitations due to spinal disorders. Mobility and physical self-care of the patients increased after introducing SCS (Table 2), but physical capacity improvement on the ODI scale was relatively smaller: only 13.34%. Although the level of disability remained considerable (Table 3), patients found it easier to carry out everyday activities, sit, and stand. They were also more socially active. Lifting heavy objects was still considered to be the most difficult task. Only one in four patients reported limitations in their professional life, which may be caused by retirement or the constant disability stated earlier.
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Statistical analysis of the obtained results showed moderate correlation between effective pain therapy and physical activity in patients treated with SCS. It is an important clue for movement therapy organization and education for this group of patients, who had been most often using passive physiotherapy so far. Patients undergoing this complicated and expensive medical procedure should be encouraged to utilize individual physiotherapy in the perioperative period (Shaw, Zaja, Pransky, Winters, & Patterson, 2005) and at home (Slade & Keating, 2010) in order to improve effectiveness of the therapy.
CONCLUSIONS This study conducted on group of 36 patients treated with SCS because of FBSS leads to the following conclusions. The efficacy of SPS in treating spinal and lower limb pain was 64%, which is similar to results obtained in other neurosurgical departments. Despite the decrease in spinal and lower limb pain, a moderate level of physical disability in the ODI scale was still observed. The decrease in root pain syndrome had the greatest influence on reducing physical disability. Failed back surgery syndrome treatment with SCS should be supplemented with movement therapy to maximize pain reduction and quality of life improvement of the patients.
REFERENCES Andersson, G. B. (1999). Epidemiological features of chronic low-back pain. Lancet, 354(9178), 581–585. Cameron, T. (2004). Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: A 20-year literature review. Journal of Neurosurgery, 100(3 Supplement Spine), 254–267. Davis, R. A. (1994). A long-term outcome analysis of 984 surgically treated herniated lumbar discs. Journal of Neurosurgery, 80(3), 415–421. Griffin, D. W., Harmon, D. C., & Kennedy, N. M. (2012). Do patients with chronic low back pain have an altered level and/or pattern of physical activity compared to healthy individuals? A systematic review of the literature. Physiotherapy, 98(1), 13–23. Gybels, J., Erdine, S., Meyerson, B., Winkelmuller, W., Augustisson, L., Bonezzi, C., Brasseur, L., DeJongste, M., Kupers, R., Marchettini, P., Muller-Schwefe, G., Nitescu, P., Plaghki, L., Reig, E., Spincemaille, G., Thomson, S., Tronnier, V., & Van Buyten, J. P. (1998). Neuromodulation of pain. A consensus statement prepared in Brussels 16-18 January 1998 by the following task force of the European Federation of IASP Chapters (EFIC). European Journal of Pain, 2(3), 203–209. Hoy, D., Brooks, P., Blyth, F., & Buchbinder, R. (2010). The epidemiology of low back pain. Best Practice & Research Clinical Rheumatology, 24(6), 769–781.
Huskisson, E. C. (1982). Measurement of pain. Journal of Rheumatology, 9(5), 768–769. Kawanishi, C. Y., & Greguol, M. (2013). Physical activity, quality of life, and functional autonomy of adults with spinal cord injuries. Adapted Physical Activity Quarterly, 30(4), 317–337. Kumar, K., Hunter, G., & Demrtia, D. (2006). Spinal cord stimulation in treatment of chronic benign pain: Challenges in treatment planning and present status, a 22-year experience. Neurosurgery, 58(3), 481–496. Kumar, K., Taylor, R. S., Jacques, L., Eladabe, S., Meglio, M., Molet, J., Thomson, S., O’Callaghan, J., Eisenberg, E., Milbouw, G., Buchser, E., Fortini, G., Richardson, J., & North, R. B. (2008). The effects of spinal cord stimulation in neuropathic pain are sustained: A 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery, 63(4), 762–770. Krasucki, M. (2005). Diagnostic and therapeutic algorithm of proceeding in back pain disorders. Rehabilitation Medicine, 9(3), 19–25. Laitinen, J. (1979). Acupuncture and transcutaneous electrostimulation in the treatment of chronic sacrolumbalgia and ischialgia. Journal of Chinese Medicine, 4(2), 12–14. Maniadakis, N., & Gray, A. (2000). The economic burden of back pain in the U.K. Pain, 84(1), 95–103.
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Niskansen, R. O. (2002). The Oswestry Low Back Pain Disability Questionnaire. A two-year follow-up of spine surgery patients. Scandinavian Journal of Surgery, 91(2), 208–211. Rutkowska, E. (2004). Physical activity in holistic medicine. Physical Education and Sport, 48, 175–186. Shaw, W. S., Zaja, A., Pransky, G., Winters, T., & Patterson, W. B. (2005). Perceptions of provider communication and patient satisfaction for treatment of acute low back pain. Journal of Occupational and Environmental Medicine, 47(10), 1036–1043. Slade, S. C., & Keating, J. L. (2010). Measurement of participant experience and satisfaction of exercise programs
for low back pain: A structured literature review. Pain Medicine, 11(10), 1489–1499. Slade, S. C., & Molloy, E. (2009). ‘‘Listen to me, tell me’’: A qualitative study of partnership in care for people with nonspecific chronic low back pain. Clinical Rehabilitation, 23, 270–280. Taylor, R. S., Van Buyten, J. P., & Buscher, E. (2005). Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: A systematic review and analysis of prognostic factors. Spine, 30(1), 152–160. Wetzel, F. T., & LaRocca, H. (1991). The failed posterior lumbar interbody fusion. Spine, 6(7), 839–845.
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From the *Department of Neurosurgery and Peadiatric Neurosurgery, Medical University of Lublin; †Department of Tourism and Recreation, University of Life Science in Lublin; ‡Department of Rehabilitation, Physiotherapy and Balneotherapy, Medical University of Lublin; § Department of Neurosurgery and Peadiatric Neurosurgery, Students Medical Association, Medical University of Lublin, Lublin, Poland. Address correspondence to Anna Mosiewicz, MD, PhD, Department of Neurosurgery and Paediatric Neurosurgery, Medical University of Lublin, Jaczewskiego St. 8, Lublin, Poland. E-mail: mosiewiczanna@ gmail.com Received September 18, 2014; Revised November 28, 2014; Accepted January 29, 2015. 1524-9042/$36.00 Ó 2015 by the American Society for Pain Management Nursing http://dx.doi.org/10.1016/ j.pmn.2015.01.004
_ Anna Mosiewicz, MD, PhD,* Elzbieta Rutkowska, PhD,† ‡ Monika Matacz, MS, Barbara Mosiewicz,§ Robert Kaczmarczyk, MD, PhD,* and Tomasz Trojanowski, MD, PhD*
ABSTRACT:
Pain in the lumbosacral part of the spine in the course of degenerative disease is the most common cause of physical activity limitation in adults. Treatment includes pharmacotherapy, physiotherapy, psychotherapy, health promotion, and sometimes surgery. Surgical treatment is not always successful, and the various clinical and psychosomatic symptoms that result from surgical treatment failure are known as failed back surgery syndrome. For some patients with this condition, spinal cord stimulation can provide relief. The aim of the work was to define subjective and objective spinal cord stimulation effects by assessing chosen disability and physical activity limitation ratios. Pain intensity, level of disability, and presence of neurological symptoms were assessed. The examination was performed twice: before the stimulator implantation and at least 6 months postimplantation. The study was conducted at the Department of Neurosurgery and Paediatric Neurosurgery in Lublin. Thirty-six patients suffering from failed back surgery syndrome were recruited for this study. The Visual Analog Scale, modified Laitinen’s pain questionnaire, and Oswestry Disability Index were used in this work. The study showed that spinal cord stimulation was effective in treating spinal and lower limb pain in 64% of patients, similar to results obtained in other departments. Although back pain and neuropathic pain radiating to the lower limbs decreased, moderate physical activity impairment was still observed according to the Oswestry Disability Index scale. The decrease in neuropathic pain radiating to the lower limbs had the most significant influence on reducing physical activity impairment. Ó 2015 by the American Society for Pain Management Nursing
Pain Management Nursing, Vol -, No - (--), 2015: pp 1-6
2
Mosiewicz et al.
BACKGROUND
MATERIALS AND METHODS
Back pain resulting from degeneration of the spine is one of the most frequent conditions affecting adults today. Disorders of the lumbosacral part of the spine are the most common causes of physical activity limitation in adults and one of the main reasons for absences from work (Andersson, 1999; Maniadakis & Gray, 2000). It is estimated that 60%-80% of the adult population suffer from this kind of pain (Hoy, Brooks, Blyth, & Buchbinder, 2010). Cases of reported back pain require careful diagnostic testing, thorough risk factor analysis, and adequate therapy. Treatment for back pain includes pharmacotherapy, physiotherapy, psychotherapy, health promotion, and—if these means turn out to be insufficient (e.g., there are symptoms of neurological disorders or the pain is unbearable)—surgery (Krasucki, 2005). The percentage of patients whose back pain is treated surgically varies across countries, ranging from 0.4% to 2.2% (Andersson, 1999). Surgery will not solve all of a patient’s medical issues; it is still necessary to introduce a secondary prevention program and lifestyle changes (Krasucki, 2005). The outcome of therapy is also influenced by how well the back pain risk factors can be controlled and active cooperation of the patient (Slade & Molloy, 2009). Surgical treatment is associated with a risk of failure. It is estimated that 8% to 25% of operations to relieve back pain do not result in satisfactory outcomes (Rutkowska, 2004; Taylor, Van Buyten, & Buscher, 2005; Wetzel & LaRocca, 1991). These patients require further treatment, often another (and sometimes multiple) surgical intervention. The various clinical and psychosomatic symptoms that result from the failure of surgical treatment are defined as failed back surgery syndrome (FBSS) and post-laminectomy syndrome. Chronic pain, which is the main component of FBSS, limits a patient’s participation in normal life activities and causes serious disability. Spinal cord stimulation (SCS) is, for a small group of these patients (qualification criteria are fulfilled by about 5% of patients), a chance to improve their quality of life (Kumar, Hunter, & Demrtia, 2006).
Thirty-six patients treated with SCS in the Department of Neurosurgery in Lublin from 2008 to 2013 took part in the study. The group consisted of 20 women and 16 men aged 43 to 80 years (mean age 59.61 9.36 years). Patients qualified for SCS after failed surgery on the lumbar part of the spine (from 1 to 8 operations). Pharmacotherapy and physiotherapy were also insufficient in treating chronic pain in the course of degenerative disease. Patients were qualified for stimulator implantation after taking their medical history, a clinical examination, and medical imaging (CT or MRI) examination. Patients with active psychiatric disorders, severe depression, hypochondriac behaviors, and histories of drug and alcohol abuse were excluded from the study. Patients’ state assessments also included clinical examination in order to determine the pain intensity and level of disability caused by FBSS. In this study the following methods were used: Visual Analog Scale (VAS) according to Huskisson (1982)—type and intensity of pain of the lumbar part of the spine as well as neuropathic pain radiating to the lower limbs were assessed, scoring from 0 (no pain) to 10 (unbearable pain) Pain assessment modified scale according to Laitinen (1979) Oswestry questionnaire (Oswestry Disability Index [ODI])—this scale consists of 10 questions concerning pain intensity, self-care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and travelling. The patient was to choose the answer that best reflected his or her situation; point values for each question range from 0 to 5, for a possible maximum score of 50. Point totals were converted to percentages (1 point ¼ 2%). On the basis of this questionnaire, five degrees of life quality impairment are determined: 0%-20%, no disability; 21%-40%, slight disability; 41%-60%, moderate disability; 61%-80%, serious disability, with pain affecting all aspects of life; 81%-100%, complete disability, patient is bedbound (Niskansen, 2002).
All examinations were performed twice: before the implantation and at least 6 months postimplantation.
RESULTS AIM OF THE STUDY The aim of this work is to assess the effectiveness of SCS in subjective (chronic pain treatment) and objective (chosen disability and activity limitations ratios) categories for this particular group of patients. Recognition of these limitations also allows us to better define the aims of functional improvement therapy for physiotherapists as well as for patients.
Patients were treated symptomatically and surgically because of pain and limitations resulting from degenerative disease of the spine. Twenty-three patients had been diagnosed with chronic comorbidities: hypertension (23), diabetes (7), and chronic obstructive pulmonary disease (4). A majority of the group (30 patients [83.3%]) were professionally inactive because of poor health and age. Between 2
3
Effects of Spinal Cord Stimulation
and 17 years had passed since the patients’ last operation. Aside from unsatisfactory surgical treatment, patients had been using the following methods to control their pain: Nonsteroidal anti-inflammatory drugs or painkillers: 36 (100%) Physiotherapy: 31 (86.1%) Massage: 22 (61.1%) Acupuncture: 6 (16.7%) Alternative medicine: 5 (13.9%) Antiepileptics: 1 (2.8%) Antidepressants: 1 (2.8%)
The intensity of spinal pain and the pain radiating to the lower extremities before spinal neurostimulator implantation was considerable, averaging 8 points on the 10-point VAS scale (Table 1). Two patients described their lumbar spine pain intensity as a 10 on the VAS scale, while 9 patients rated their pain at 9. Neuropathic pain of the lower limbs was rated at 10 on the VAS scale by 4 patients and as a 9 by 10 patients. Particular components of the four-point Laitinen scale were similarly high: pain intensity (2.94 0.53), pain frequency (3.5 0.81), painkiller use (2.69 0.53), and physical activity limitation caused by pain (2.47 0.73). Total pain assessment on the Laitinen scale (minimum 0, maximum 16) was 11.61 2.09 points. All patients who qualified for SCS displayed root pain syndrome upon physical examination. Neurological disorders and pain caused physical activity limitation in these patients; according to the pre-implantation ODI, it was assessed as serious (73.5% 5.11%). Treatment with spinal cord neurostimulation was effective in lowering the pain level (Table 1). According to the Laitinen pain scale results, pain intensity decreased after implantation in 35 patients (97.22%), with 1 patient reporting no improvement. On the basis of the responses to the Oswestry questionnaire concerning pain, improvement was reported by 33
patients (91.7%) and deterioration was observed by 3 patients (8.3%). Similar results were obtained in assessments of back pain treatment using the VAS scale. Almost all patients (35 [97.22%]) reported a decrease of pain. One patient did not observe any changes after the implantation. Assessment of pain radiating to the lower limbs on the VAS scale showed slightly worse results: pain reduction was reported by 32 patients (88.89%), 3 patients (8.33%) did not observe any improvement, and 1 patient (2.78%) reported worsening pain. Average intensity of back and lower limb pain decreased in the group as a whole (Table 1). Spinal stimulator implantation improved the average rates of physical activity as assessed with the Oswestry questionnaire (Table 2). In the assessment of physical dysfunction caused by back pain, serious disability (61%-80%) was observed before implantation of spinal stimulator. Six or more months after the implantation, the disability level was lower, but it ranged between moderate and serious disability (Table 2). The effects of SCS therapy on pain reduction were assessed according to the increase of physical activity as rated on the Laitinen scale. Postimplantation, physical activity limitation was 1.23 points lower than the pre-implantation rating. One patient (2.78%) reported that pain did not affect physical activity before and after operation. Twenty-three patients (63.89%) reported improvement after neurostimulation therapy, 11 patients (30.55%) did not observe any changes, and one patient (2.78%) reported deterioration. Assessment with the Laitinen scale led to the conclusion that the number of patients with no or partial physical activity limitations increased after the operation (Table 3). Patients reported impairment in all categories included in the Oswestry questionnaire. In this study, ODI categories concerning physical activity were assessed. The average results in categories concerning physical capacity are presented in Figure 1. Results of clinical examinations were used to define the relationship between decreased pain
TABLE 1. Change in Pain Intensity for Patients (n ¼ 36) Treated with Spinal Cord Stimulation Pain Assessment on the Laitnen Scale
Back Pain on the VAS
Lower Limb Pain on the VAS Scale
Pain Assessment
Before SCS
After SCS
Difference
Before SCS
After SCS
Difference
Before SCS
After SCS
Difference
Average SD
11.61 2.09
5.58 2.93
6.03 3.00
7.67 1.93
4.28 2.20
3.39 2.57
7.61 2.19
4.00 2.75
3.61 3.27
SCS ¼ spinal cord stimulation; SD ¼ standard deviation; VAS ¼ Visual Analog Scale.
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TABLE 2. Activity Impairment Ratios in the Oswestry Disability Index (n ¼ 36) Result
Disability in ODI
Category
Before SCS
After SCS
Difference
Mean SD Level of disability
36.75 5.11 73.50% 10.22 (Serious)
30.08 8.40 60.16% 16.80 (Moderate)
6.67 8.36 13.34% (16.72)
ODI ¼ Oswestry Disability Index; SCS ¼ spinal cord stimulation; SD ¼ standard deviation.
level on the VAS scale and Laitinen questionnaire, and physical activity improvement. Statistical analysis with Spearman’s correlation rank coefficient (p < .05 was stated as statistically significant) showed that: Decreased back pain in the VAS scale after implantation moderately lowers the level of disability (R ¼ .51; p ¼ .002) assessed with the Oswestry questionnaire; it also improves travelling (R ¼ .48; p ¼ .005) and walking (R ¼ .43; p ¼ .014) capacities. Decreased neurogenic pain of the lower limbs after SCS application moderately improved levels of self-care (R ¼ .56; p ¼ .0008), walking capacity (R ¼ .56; p ¼ .0006), social life (R ¼ .50; p ¼ .002), quality of travelling (R ¼ .49; p ¼ .0009), and lifting ability (R ¼ .44; p ¼ .01) according to the Laitinen pain questionnaire. There is a statistically significant correlation between a decrease in lower limb pain and level of disability according to the ODI (R ¼ .65; p ¼ .04).
All other attempts at finding statistical correlation did not lead to any significant results.
DISCUSSION Physical capacity is of intrinsic and instrumental value in all aspects of life quality. According to the holistic approach in medicine, physical activity is thought to
TABLE 3. Physical Activity Limitation before and after Spinal Cord Stimulation One the Laitinen Scale Before SCS
After SCS
be an important preventive, diagnostic, and therapeutic factor (Rutkowska, 2004). This is why assessment of physical disability level in chronic diseases is a significant measure of life quality, which supplements clinical examination. Physical and life activity limitation results from chronic and refractory pain and diseases affecting the spine and the spinal cord (Griffin, Harmon, & Kennedy, 2012). These ailments often are followed by psychoreactive syndromes, which significantly lower quality of life (Kawanishi & Greguol, 2013). Since the 1980s, therapy with SCS has been available for patients for whom other treatment modalities (including surgery) have been ineffective (Kumar, Hunter, & Demrtia, 2006). Every year, approximately 15,000 patients worldwide are treated with this method because of neuropathic and ischemic pain (Cameron, 2004). In Europe, approximately 5000 stimulators are implanted because of pain of various origins (Gybels et al., 1998). The aim of this work was to assess the efficacy of treatment with neurostimulation from the patient’s perspective. This part of the study was the supplementation of clinical examination. Therapy effectiveness assessment in clinical categories (reduction of pain and neurological disorders) should be supplemented by assessing improvement of functioning in everyday life. An objective measure of neurostimulation efficacy was determined by comparing the intensity and type of pain reported before the implantation with the pain after SCS
n
%
n
%
No limitation 1 2.78 5 13.89 Partial 2 5.56 16 44.44 Professional activity impairment 12 33.33 9 25.00 Requiring partial help 21 58.33 6 16.67 Requiring complete help 0 0 0 0 Sum 36 100 36 100 SCS ¼ spinal cord stimulation.
4.06
2.44
traveling
3.78
2.25
social life
3.72
2.28
sitting
Physical Activity Limitations
before SCS
standing
3.39
1.86
walking
3.14
2.03
lifting daily activity
1.66
0
1
2
4.13
3.11 2.89
score
3
4
5
FIGURE 1. - Physical activity impairment before and after spinal cord stimulation (SCS) on the Oswestry Disability Index (n ¼ 36).
Effects of Spinal Cord Stimulation
reported at least 6 months postimplantation. (The 6-month delay in reevaluating pain was to prevent the confusion of pain related to the operation with chronic pain). Effective pain therapy should also result in increased levels of activity for the patients. Patients who qualified for the operation suffered from pain of the spine and lower limbs (as rated on the VAS scale) and showed a serious level of disability (based on the results of the ODI) (Tables 1 and 2). Although the results of the treatment varied among individual patients, in most patients (64%) there was decrease of pain observed, which is similar to results obtained in other departments (Cameron, 2004; Davis, 1994; Kumar et al., 2006, 2008). According to the VAS and Laitinen scale, pain was one-third lower in both scales and approximately 14% of patients did not report any physical activity limitations due to spinal disorders. Mobility and physical self-care of the patients increased after introducing SCS (Table 2), but physical capacity improvement on the ODI scale was relatively smaller: only 13.34%. Although the level of disability remained considerable (Table 3), patients found it easier to carry out everyday activities, sit, and stand. They were also more socially active. Lifting heavy objects was still considered to be the most difficult task. Only one in four patients reported limitations in their professional life, which may be caused by retirement or the constant disability stated earlier.
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Statistical analysis of the obtained results showed moderate correlation between effective pain therapy and physical activity in patients treated with SCS. It is an important clue for movement therapy organization and education for this group of patients, who had been most often using passive physiotherapy so far. Patients undergoing this complicated and expensive medical procedure should be encouraged to utilize individual physiotherapy in the perioperative period (Shaw, Zaja, Pransky, Winters, & Patterson, 2005) and at home (Slade & Keating, 2010) in order to improve effectiveness of the therapy.
CONCLUSIONS This study conducted on group of 36 patients treated with SCS because of FBSS leads to the following conclusions. The efficacy of SPS in treating spinal and lower limb pain was 64%, which is similar to results obtained in other neurosurgical departments. Despite the decrease in spinal and lower limb pain, a moderate level of physical disability in the ODI scale was still observed. The decrease in root pain syndrome had the greatest influence on reducing physical disability. Failed back surgery syndrome treatment with SCS should be supplemented with movement therapy to maximize pain reduction and quality of life improvement of the patients.
REFERENCES Andersson, G. B. (1999). Epidemiological features of chronic low-back pain. Lancet, 354(9178), 581–585. Cameron, T. (2004). Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: A 20-year literature review. Journal of Neurosurgery, 100(3 Supplement Spine), 254–267. Davis, R. A. (1994). A long-term outcome analysis of 984 surgically treated herniated lumbar discs. Journal of Neurosurgery, 80(3), 415–421. Griffin, D. W., Harmon, D. C., & Kennedy, N. M. (2012). Do patients with chronic low back pain have an altered level and/or pattern of physical activity compared to healthy individuals? A systematic review of the literature. Physiotherapy, 98(1), 13–23. Gybels, J., Erdine, S., Meyerson, B., Winkelmuller, W., Augustisson, L., Bonezzi, C., Brasseur, L., DeJongste, M., Kupers, R., Marchettini, P., Muller-Schwefe, G., Nitescu, P., Plaghki, L., Reig, E., Spincemaille, G., Thomson, S., Tronnier, V., & Van Buyten, J. P. (1998). Neuromodulation of pain. A consensus statement prepared in Brussels 16-18 January 1998 by the following task force of the European Federation of IASP Chapters (EFIC). European Journal of Pain, 2(3), 203–209. Hoy, D., Brooks, P., Blyth, F., & Buchbinder, R. (2010). The epidemiology of low back pain. Best Practice & Research Clinical Rheumatology, 24(6), 769–781.
Huskisson, E. C. (1982). Measurement of pain. Journal of Rheumatology, 9(5), 768–769. Kawanishi, C. Y., & Greguol, M. (2013). Physical activity, quality of life, and functional autonomy of adults with spinal cord injuries. Adapted Physical Activity Quarterly, 30(4), 317–337. Kumar, K., Hunter, G., & Demrtia, D. (2006). Spinal cord stimulation in treatment of chronic benign pain: Challenges in treatment planning and present status, a 22-year experience. Neurosurgery, 58(3), 481–496. Kumar, K., Taylor, R. S., Jacques, L., Eladabe, S., Meglio, M., Molet, J., Thomson, S., O’Callaghan, J., Eisenberg, E., Milbouw, G., Buchser, E., Fortini, G., Richardson, J., & North, R. B. (2008). The effects of spinal cord stimulation in neuropathic pain are sustained: A 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery, 63(4), 762–770. Krasucki, M. (2005). Diagnostic and therapeutic algorithm of proceeding in back pain disorders. Rehabilitation Medicine, 9(3), 19–25. Laitinen, J. (1979). Acupuncture and transcutaneous electrostimulation in the treatment of chronic sacrolumbalgia and ischialgia. Journal of Chinese Medicine, 4(2), 12–14. Maniadakis, N., & Gray, A. (2000). The economic burden of back pain in the U.K. Pain, 84(1), 95–103.
6
Mosiewicz et al.
Niskansen, R. O. (2002). The Oswestry Low Back Pain Disability Questionnaire. A two-year follow-up of spine surgery patients. Scandinavian Journal of Surgery, 91(2), 208–211. Rutkowska, E. (2004). Physical activity in holistic medicine. Physical Education and Sport, 48, 175–186. Shaw, W. S., Zaja, A., Pransky, G., Winters, T., & Patterson, W. B. (2005). Perceptions of provider communication and patient satisfaction for treatment of acute low back pain. Journal of Occupational and Environmental Medicine, 47(10), 1036–1043. Slade, S. C., & Keating, J. L. (2010). Measurement of participant experience and satisfaction of exercise programs
for low back pain: A structured literature review. Pain Medicine, 11(10), 1489–1499. Slade, S. C., & Molloy, E. (2009). ‘‘Listen to me, tell me’’: A qualitative study of partnership in care for people with nonspecific chronic low back pain. Clinical Rehabilitation, 23, 270–280. Taylor, R. S., Van Buyten, J. P., & Buscher, E. (2005). Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: A systematic review and analysis of prognostic factors. Spine, 30(1), 152–160. Wetzel, F. T., & LaRocca, H. (1991). The failed posterior lumbar interbody fusion. Spine, 6(7), 839–845.