Pain and Cervical Dystonia

Abstract

Cervical dystonia is a neurological disorder affecting the voluntary muscles in the neck with spasmodic and involuntary movements. A majority of patients with Cervical dystonia experience pain. Most studies in this area of the research study the effectiveness of the drug, Botulinum toxin A, also known as Botox, on the treatment of the disorder but fail to represent the patients’ viewpoint on the drug’s effectiveness upon the reduction of pain. The aim of this empirical review is to evaluate the use of botulinum toxin A as management for the condition from the perspective of the patient. This study will strive to understand the patients’ experience of being treated with Botox for the treatment of cervical dystonia. Quantitative and qualitative random sampling designs will be used to examine patients and non-patients suffering from cervical dystonia. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and the Brief Pain Inventory (BPI) will be used to assess the patient’s view of the effectiveness of Botox on the reduction of pain and symptoms of cervical dystonia. The data will be used to determine if Botox is an effective evidence-based pain management strategy for pain related to cervical dystonia. Hopefully, the results of this study will encourage nurses to utilize pain measurement as a way to measure the effectiveness of interventions, particularly in the treatment of cervical dystonia.

Background and Statement of Problem

Cervical dystonia is a medical condition that affects the voluntary muscles of the neck, characterized by prolonged muscular contraction. This causes repetitive movements and twisting, in addition to abnormal posture in the affected area. In most cases, the patient experiences pain.

Previously, the term spasmodic torticollis was used to refer to the condition. According to Pappert and Germanson (2008), cervical dystonia is a highly inconsistent neurological condition that is characterized by spasms or involuntary movement of the muscles of the neck. Cervical dystonia manifests as an abnormal contraction of the muscles of the neck, which causes these muscles to involuntarily move and spasm, most commonly with the chin moving towards the shoulder (Walker, 2003).

In the U.S, approximately 500,000 people are diagnosed with the condition. It is vital to note that approximately 500,000 people are either misdiagnosed or not diagnosed at all (Pappert & Germanson, 2008). Some patients are given x-rays and sent to a chiropractor. Most people do not recognize the preliminary tremors where the head involuntarily shakes back and forth, for instance, occurring with the onset of the condition. The high incidence rate makes cervical dystonia one of the most common movement disorders after Parkinson’s disease and essential tremors. Cervical dystonia affects all groups of people regardless of social-economic barriers, age or ethnicity.

The cause of the condition is not known, but it is postulated that there is a hereditary connection to the condition. There is a high prevalence of the condition in women than in men. Globally, approximately 4 million people have the condition. 90 percent of these patients experience pain. Camargo, Teive, Becker, Baran, Scola, and Werneck (2008) found that in a population of 45 patients with cervical dystonia, the severity of abnormal neck and head movement measured using the TWSTRS scale was higher among patients with the generalized form of the condition than patients with focal dystonia. Their study also established that these patients experienced different levels of pain. In this case, 69.4 percent of the population with the condition experienced pain around the neck and shoulder regions. Additionally, 72.9 percent of the patients reported moderate pain and 70.6 percent identified jerks and spasms (Camargo, Teive, Becker, Baran, Scola & Werneck, 2008). A comparison of patients with a combination of cervical dystonic movement showed increased complaints of pain.

Broad ranges of therapies are available for the treatment of the medical condition. Some of these therapies include brain surgery and clinical treatment, in addition to postoperative aromatherapy to supplement relief and peripheral surgery (Comella, 2008). These treatments have however not been very effective towards elimination and control of the condition in the past, as Kraussa, Toupsa, Jankovicb, and Grossmana (1997) revealed. However, Kraussa et al. found that surgeries tailored to the progression of the disorder in the individual are a suitable approach to treating the disorder with surgery. In their results, a personalized approach to the surgical intervention had a long-term reduction of symptoms for 89% of patients after six and a half years. However, this also meant multiple surgeries, and the higher the number of surgeries, the better the outcome for the individual.

Kraussa et al. (1997) criticized that while botox injections to control the muscle spasm of cervical dystonia, they must be injected three to four times a year and their effects are short-term: Yet, the treatment is widely used as the treatment of choice. Botulinum toxin A is injected directly into the muscles. Studies conducted on botulinum toxin A treatments indicated a 42.35% effectiveness in reducing symptoms (Comella, 2008).

While research is extensive in the treatment of the condition with varying outcomes, one dimension of the condition that has been understudied is the controlling of pain in cervical dystonia. Moreover, the available research is deficient in the effectiveness of botulinum toxin A in the treatment of the pain associated with cervical dystonia. Therefore, it is the purpose of this study to learn the effectiveness of botulinum toxin A in reducing the pain associated with cervical dystonia. In measuring pain as an indication of treatment effectiveness, it is hoped the results of this research will help encourage the measurement of pain as a way to gauge the effectiveness of treatment.

Literature Search

Clinical Question and PICOT

The clinical question that guides this paper is: What is the patient’s experience of being treated with botox for treatment of cervical dystonia? To formulate the clinical question, the PICOT format was utilized. The PICOT criterion was determined as follows:

(P) is the patient issue: The patient who has cervical dystonia.

(I) represents the intervention or variable of interest: Patients receiving Botox injections.

(C) is the comparison of groups. In this study, groups are not compared.

(O) is the levels of pain.

(T) stands for different time points. In this study, it is after the botox injections.

Therefore the research question according to PICOT format is as follows:

How do patients with cervical dystonia (P) who have received botox injections (I) perceive their pain level (O) after the intervention is administered (T)?

An identification of the clinical research question, one can derive key search words: cervical dystonia, cervical dystonia and pain management, cervical dystonia, botox injections, and pain management, were all utilized in various combinations to reveal progress and gaps in the literature. The following databases were utilized for the search: Cochrane, CIHAHL, PubMed, Medline, and EBSCO.

The following literature review explains some key concepts that are important in understanding the treatment of dystonia. These concepts are well-established in the literature. A summary of botox serums will be provided. The gap in the literature will be explained, demonstrating a need for this study.

Literature Review

In reviewing the literature, it is helpful to develop a full understanding of the different types of botox serums available in the treatment of cervical dystonia, as well as develop an understanding of the history of using botox type serums in the treatment of this disorder. First, a historical summary of the use of botox injections in the symptom management of the disorder is offered, followed by an explanation of the different types of serums and the research available to understand their effectiveness in the treatment of cervical dystonia.

Historical Overview of Botulinium Toxin A Therapy for Cervical Dystonia

According to a qualitative review of the therapy, Francis Walker (2003) established a clear comprehension of the history of cervical dystonia. According to Walker (2003) innovativeness in the medical field led to the introduction of botulinum toxin A as an effective treatment for the condition. The introduction of this strategy silenced most practitioners who thought that the condition was psychogenic. Additionally, the introduction of the treatment approach introduced the medical field to the novel therapeutic potentials of botulinum toxins (Fahn, Bressman & Marsden, 2010).

Finding on Treatment of Cervical Dystonia with Botox Injections

The signs of cervical dystonia specifically show at the neck. Botulinum toxin A has an immense influence on the contraction of muscles (Walker, 2003). Walker demonstrated the drug’s crucial role in intervening in the muscle spindle activity. However, some studies have successfully shown that botulinum toxin A prevents muscles from discharging substances from the nerve endings. A combination of these studies shows that there are wide-ranging indications for the toxin that have not been explored.

The toxin, harvested from Clostridium botulinum, when injected into the contracting muscles, prevents the release of acetylcholine by diffusing into the nerve terminals and helps in stopping the ongoing muscular contractions, which relieves the dystonic movements. The onset of the effects of the toxin takes a few weeks, but the effects last for months, and efficacy is 70 percent (Walker, 2003). According to Comella and Thompson (2006), botox injections do carry with it some side effects. Adverse effects of the toxin include excessive local weakness in the neck region, excessive oral dryness, and dysphagia.

Before using any of the serotypes of botulinum toxin, it is essential to understand the underlying anatomy and the 54 different muscles influencing the neck and head movement (Walker, 2003). The clinical spectrum of the abnormal neck and head postures and movements in cervical dystonia is highly variable (Walker, 2003). Moreover, as Walker explained, each patient must be assessed for how the muscle contractions are affecting their head movements in order to inject the correct muscles in the neck for the therapy to be effective. Different serums are used in the treatment and have been well established in the literature.

Different serotypes of botulinum toxin A are analyzed during the study of the individualized management of the condition. It is necessary to understand the therapeutic advances and risks associated with the treatment approach. Pappert and Germanson (2008) demonstrated that there is no discrepancy between the different serotypes of botulinium toxin A. This study found that botulinium toxin A effectively dealt with the severity of pain and movement disabilities associated with the condition.

Though botulinum toxin A has shown effectiveness in the treatment of cervical dystonia, Dauer (1998) demonstrated that 5-10 percent of the patients are unresponsive to the treatment. According to this study, several factors can lead to unresponsiveness to the treatment. One possible factor is the patient may develop neutralizing antibodies during the period of treatment. Some of the patients may develop antibodies, which renders the toxin ineffective, which was more likely to occur with serotype B.

Gap in the Literature

While treatment comparison for resolving the disorder is thoroughly studied, and an important and urgent area of study for understanding the treatment of cervical dystonia, noticeably absent from the literature is the patient’s experience of pain reduction from botox injections in the treatment of cervical dystonia. Given that an overwhelming majority of patients with cervical dystonia experience pain resultant of the disorder, in order to meet the needs of the patient, pain reduction is vital in the treatment of this disorder, and an effective measure as to the effectiveness of the treatment. As Guyer (1999) stated, the use of botox in the treatment of cervical dystonia is well-known for pain reduction. However, there are no studies available to prove its effectiveness in terms of the amount administered, mapping the muscles in need of injections, the experience of the doctor administering the treatment, and many other factors that need to be understood in studying pain reduction for patients with cervical dystonia.

Also, there is a conspicuous gap in the literature in the use of measurement tools to garner the effectiveness of treatment of pain in individuals. Even if there is a reduction of symptoms of the disorder, it does not guarantee a reduction in pain. Since the pain can be the most disabling factor of any condition and the overwhelming majority of patients with cervical dystonia experience pain, pain reduction should be studied and prioritized in research so physiological and biochemical mechanisms are better understood as well as the effectiveness of treatment in pain reduction. Patients with addiction issues should also be provided with non-habit forming alternatives.

Theory Basis for Study: Roger’s Science of Unitary Human Beings

The theory postulates a suitable nursing framework for the clinical management of patients admitted in Cervical Dystonia. The fundamental principles of the theory postulate that nursing activities and endeavors should venture to promote wellbeing for all persons, and people should be treated holistically; hence, recovery will be accorded total consideration in the light of the experience of the patient (Rodgers, 1989). This means that the project outcome depends on the fact that care needs to embrace gradual attainment of recovery through trials of different combinations of therapeutic approaches, as well as, regimes and statistically monitoring the response of the patients

Methodology

Study Design

This project will employ quantitative and qualitative random sampling designs to examine patients and non-patients suffering from cervical dystonia. The study will be conducted using Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) to qualify the participants in the study and the Brief Pain Inventory (BPI) to assess their pain level before and after the botox injections in clinics in Toronto.

Sample Selection Criteria

The subjects will be randomly selected from a group of patients that show signs of the Cervical Dystonia. A total of 60 people will be selected, 30 patients who will form the main subjects of the study and 30 healthy persons who will be used to represent the control experiment. Another criterion that will be used in the determination of the patients will be classified according to the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).

Inclusion and Exclusion Criteria

Only 30 patients who suffer from cervical dystonia will be included. A group of 30 patients that show signs of the Cervical Dystonia will be included and those who do not show signs of dystonia will be excluded. A total of another 30 people who are healthy and may be susceptible to cervical dystonia will also be included in the study.

Procedure

A proposal will be submitted to the local ethics committee to obtain permission for the study. All the participants or subjects will also be issued with written consent. The patients will be identified with serial numbers and then they will be placed on regular treatment with botulinum injections after every three months for the experimental period. These patients will be investigated after every two weeks before the next treatment is administered. The healthy persons will also be identified by serial numbers and tested for cervical dystonia after every two weeks.

Dependent Variable

TWSTRS scores and Brief Pain Inventory scores before treatment will be the dependent variables that will be measured using the Toronto Western Spasmodic Torticollis Rating Scale.

Independent Variable

The independent variables will be the scores on the TWSTRS score and the BPI score obtained after the intervention, the botox injections, are applied.

Instruments for Measuring Variables

The TWSTRS inventory is well established in its usefulness in detecting cervical dystonia, with reliability coefficients at .70 and above (Boyce, Canning, Mahant, Morris, Latimer, & Fung, 2012). There are three questions to assess the dimension and severity of pain. The Brief Pain Inventory (BPI) was selected for use for measuring levels of pain in participants. Keller, Bann, Dodd, Schein, Mendoza, and Cleeland (2004) noted that the BPI, originally formulated for measuring pain in cancer patients, has reliability and validity for populations with other disorders where pain is a factor, with an alpha coefficient of over .70, and will serve as an appropriate compliment in the measurement of pain reduction after botox injections as well as provide an opportunity to test its use amongst patients with cervical dystonia.

Interviews and Questionnaires

The collection of data for the experimental setup will involve the use of oral interviews administered to the patients. These interviews will involve several questions that will test the oral clinical diagnostic aspect of the patients and the other subjects in the experimental setup. Other criteria that will be used in data collection will be the use of questionnaires.

Descriptive Statistics

The data from the study will be analyzed using tables, frequencies, percentages, and the distribution curve. Descriptive statistics will include frequency and percentage of categorical variables including sex, age, and BDI. Bivariate analysis including the Pearson Correlation Coefficient will be performed to examine the relationship between cervical dystonia sores and disease duration. Chi-square will be performed to examine differences in a number of patients assessed and people not having the symptoms. The data will also be analyzed using Kolmogorov – Smirnov test. Other comparisons between the CD and the HC groups will be done using the student T-test specifically for the independent samples with two tails in their probability. Mann – Whitney will be employed in the analysis of both parametric and the non-parametric data used in the study. The linear Pearson’s rho system will also be used in the analysis for any additional correlations in the study. T-tests will be performed to assess if there is a clinically significant difference in pain levels before and after the botox injections in TWSTRS and BPI inventories.

Dissemination

During the administration of botulinum toxin, patients will be encouraged and educated on the major significance of carrying out the research. All the stakeholders including the participants in the research, hospitals that will be involved, and other state organizations will be appreciated in order for them to continue involving themselves in this study for its success. In order to encourage change in practice, the change theory can be used as a model to create change in practice. The change theory, explained by Schein (1995), is a three-part process. First, inertia must be overcome. Second is the change phase. In the third stage, the new implementation is crystallized into practice.

It is the hope of this researcher that the reassessment of the TWSTRS and BPI inventory after administration of the botox injections will help nurses become more aware of being more sensitive to the needs of patients. Pain reduction is considered a basic need (Centers for Medicare and Medicaid Services (CMS), 2013). This study will strive to overcome inertia in practice to show the necessity of testing patients for pain after treatment as a way to meet the needs of patients. Hopefully, with more studies like this, this practice will be implemented and used in the future.

References

Boyce, M. J., Canning, C. G., Mahant, N., Morris, J., Latimer, J., & Fung, V. S. (2012). The Toronto Western Spasmodic Torticollis Rating Scale: reliability in neurologists and physiotherapists. Parkinsonism Relat Disord., 18(5), 635-7. DOI: 10.1016/j.parkreldis.2012.02.007. Epub 2012 Mar 8.

Centers for Medicare and Medicaid Services (CMS). (2013). HCAHPS: Patients’ perspective of care survey. Retrieved from http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/HospitalHCAHPS.html

Comella, C. (2008). The treatment of cervical dystonia with botulinum toxins. Journal of Neural Transmission, 115, 579–83.

Comella, L. & Thompson, P. D. (2006). Treatment of cervical dystonia with botulinum toxins. Eur J Neurol. 13 (Suppl 1), 16-20.

Fahn, S., Bressman, B., Marsden, D. (2010). Classification of dystonia. Adv Neurol., 78, 1-10.

Guyer, B. M. (1999). Mechanism of botulinum toxin in the relief of chronic pain. Current Review of Pain, 3(6), 427-431.

Keller, S., Bann C. M., Dodd, S. L., Schein, J., Mendoza, T. R., & Cleeland, C. S. (2004). Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 20(5):309-18.

Kraussa, J. K., Toupsa, E. G., Jankovicb, J., & Grossmana, R. J. (1997). Symptomatic and functional outcome of surgical treatment of cervical dystonia. J Neurol Neurosurg Psychiatry; 63,:642-648. DOI:10.1136/jnnp.63.5.642

Pappert, J., & Germanson, T. (2008). Botulinum toxin type B vs. type A in toxin-naïve patients with cervical dystonia: Randomized, double-blind, non-inferiority trial. Myobloc/Neurobloc European Cervical Dystonia Study Group, 23, 510-7.

Rogers, M. E. (1989). An Introduction to the Theoretical Basis of Nursing. Philadelphia: F. A. Davis

Schein, E. H. (1995). Kurt Lewin’s change theory in the field and in the classroom: Notes towards a model of managed learning1. MIT. Retrieved from http://dspace.mit.edu/bitstream/handle/1721.1/2576/SWP-3821-32871445.pdf

Walker, F.O. (2003). Botulinum toxin therapy for cervical dystonia. Physical Medicine and Rehabilitation Clinics of North America, 14, 749-766.

(APPENDICES A & B omitted for preview. Available via download)