Spinal Manipulation Therapy - Research Proposal Example

Spinal Manipulation Therapy xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Name Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Course Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Instructor Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Date Submitted Contents Contents 2 1.0.Introduction 3 2.0.Background 4 2.0.1. Research question 4 2.0.2. Hypothesis 5 2.0.3. Rationale 5 2.0.4. Aims and objectives 7 3.0.Literature Review 7 4.0.Methodology 11 4.0.1. The clinical interventions 12 5.0.Expected outcome measures 13 6.0.The statistical analysis 14 7.0.Expected results 15 8.0.Conclusion 15 References 16 1.0. Introduction According to Cecchi, et al (2010), back pain is considered to be one of the most pervasive complain within health systems. It is estimated that more than 50% of the world population experience back pain each year. This problem is not devastating health wise but also it is negatively affecting the economy as billions of dollars is being used on medical services in treating back pain. One of the most challenging aspects observed in treating back pain is that in most instances medical practitioners indicate that it is very difficult to identify its causative factor (Cecchi et al, 2010). Therefore, sufficient treatment of Low Back Pain (LBP) is an important aspect for patients, health care policy makers and practitioners. It is quite evident that one major factor which explains these increased costs in dealing with low back pain is the gradual recurrence and chronic disability that result from these pains. 2.0. Background Lack of identifying causative factor on low back pain cases, traditional medical practice has not in any way been successful in treating this problem. It is for this that many individuals have sought alternative and complementary care. There are three main treatments of back pain namely; spinal manipulation, massage therapy and acupuncture. Even with the frequent use of these three treatments, there has been great scrutiny for safety and treatment, effectiveness and cost. In the past decades, there have been the developments of various strategies to reduce low back pain. However, primary prevention seems to be an unattainable goal due to the many factors related to the pains. It is evident that today, pathophysiology researchers on LBP highly considers both tertiary and secondary prevention to be sufficient and efficient treatment with wide focus on reducing cost (Cecchi et al, 2010). 2.0.1. Research question From the above introduction and background of low back pains. The following research questions were necessary in finding information regarding low back pains and their treatment. These two main research questions are; Are there any discrepancies related to the use of spinal manipulation of low back pain? Does the effectiveness of manipulating low back pain treatment outweigh the risks involved? 2.0.2. Hypothesis From acute researchers from various sources on law back pain and the efficacy of spinal manipulation as its treatment a major hypothesis was designed. The hypothesis is meant to measure the balance in understanding the use of spinal cord manipulation in the treatment of low back pains which affects a large percentage of the world’s population. This measure will be of assistance in trying to understand the two research question with wide focus on the effectiveness of spinal cord manipulation as the main treatment of low back pains. Therefore the hypothesis designed is; Spinal manipulation therapy is an effective and has no discrepancies associated with it in the management of low back pain 2.0.3. Rationale Herbert & Kent (2005) maintains that, spinal cord manipulation is a considered to be a common treatment for low back pain way since memorial where it was used by traditional health practitioners from various cultures across the world. In the 80s, introduction of both osteopathic medicine and chiropractic put an emphasis on the use of spinal manipulation therapy for the treatment of low back pains. According to Stubenrauch (2011), this treatment has been attributed to create certain effects on the patients. These effects are; bringing relief of musculoskeletal pain at a patient lower back, ensuring there is a positive alteration of sensory motor integration and finally, increased passive motion range especially within the synovial joints at the lower back. In Bronfort meta-analysis, there is an indication that effectiveness of spinal manipulation ranges from 54% to 84% compared patients receiving the same kind of treatment that does not incorporate spinal cord manipulation. Reviews carried out between 2006 and 2007 indicated that spinal cord manipulation was the best therapy in managing low back pains. Spinal manipulation is the most common treatment widely used by chiropractors across the globe. Although the exact mechanisms in which spinal manipulation reduces low back pains are uncertain, various models have been suggested but researchers are trying to find the effectiveness of spinal manipulation. Various reviews of randomized trials concerning low back pain and spinal manipulation as its main treatment have brought to the conclusion that there exist strong evidence that indicate that spinal manipulation is amore effective treatment for LBP as compared to other known treatments(Stubenrauch, 2011). Evidently, there are certain observable short term effects brought about by spinal manipulation which have been seen to create controversies and conflicting information in regard to spinal manipulation as a superior treatment of LBP. However, even with these short term effects there is substantial growth in evidence which support spinal manipulation as a more sufficient and efficient compared to placebo treatment. It is due of the above reason that this study finds a rationale in stating that Spinal manipulation therapy is an effective and has no discrepancies associated with it in the management of low back pain. This will be supported by obtaining information regarding any form of discrepancies which surrounds the use of spinal manipulation in treating LBP as well as finding out how effective is the use of spinal manipulation out weighs the risk involved(Herbert & Kent 2005). 2.0.4. Aims and objectives This paper presents various aims in assessing the effectiveness of spinal manipulation in treatment of LBP. The main aims and objectives that emanates from this study is; To evaluate effectiveness of spinal manipulation in managing low-back pain To determine if there are any discrepancies related to spinal manipulation of low back pain 3.0. Literature Review Assendelft, W, et al, (2003), Spinal manipulative therapy for low back pain: A meta-analysis of effectiveness relative to other therapies. Annals of Internal Medicine 138 (11), 871–881. The author widely focuses on the field of physiology whereby the purpose of his article is to resolve the discrepancies that surrounds the use of spinal manipulation in LBP treatment. The author seem to support the above designed hypothesis in that he is involved in the updating of previous estimates on efficacy of spinal manipulation in treating LBP. Assendelft et al, (2003) asserts that, spinal manipulation is known to have a prominent role in all renowned national guides in the management of back pains. The article is qualitative study where by it incorporates adult patients suffering from LBP regardless of the kind of radiation pattern they poses as well as comparing manipulation for LBP treatment to another treatment. According to Assendelft, W, et al, (2003), the treatment has both statistical and clinical benefits compared to other therapies. The therapy is more effective when it si compared to placebo treatment. There is increased effectiveness of spinal manipulation in both acute and chronic LBP. Compared to therapies such as analgesic, physical and exercises, spinal manipulation is superior as no information was found to indicate the vice versa. Present studies give an indication that patient that suffer from acute LBP engages in spinal manipulation for short term improvement. Cherkin, D. C., Sherman, K. J., Deyo, R. A., & Shekelle, P. G. (2003). A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med, 138(11), 898-906. Here, the author compares the effectiveness of acupuncture, massage therapy and spinal manipulation. Cherkin (2003) asserts that, evidence known to support acupuncture treatment for LBP patients’ remains controversial. Although the treatment has demonstrated benefits over method such as Transcutaneous Electric Stimulation Nerve Stimulation (TENS), never has TENS been considered to be the best method compared to other known methods. This reason is why this method is questionable based on its effectiveness. Research indicate that there are complications that are associated to the method in that the use of needles made patient faint or reported of high exacerbation of treatments. Based on the massage therapy, reports have reported on the effectiveness of massage for LBP patients. However, this is controversial since many patients are subjected to an inconsistent design in relation to the environment in which the therapy was under taken. Cherkin (2003) maintains that, massage therapy is considered to have a certain measurable degree of effectiveness compared to other therapies for LBP. Few literature is provided on injury during a massage therapy. Report indicates that there is cost saving when a patient decides to use massage compared to self care or acupuncture. Cherkin 2003 maintains that, spinal manipulation is most commonly performed among chiropractors and still remains as the common treatment for LBP. The evidence connected to the effectiveness of spinal manipulation is controversial. Cherkin (2003) maintains that, it demonstrates effectiveness when compared to sham therapies making it neither effective nor ineffective. Incident related to injury brought about by spinal manipulation are minimal since they are widely concentrated around the cervical region. Cherkin (2003) indicate that, there are various challenges in evaluating effectiveness of various therapies found in LBP treatment. When procedures are studies in given researches, it is normally subjected to a method which is uncharacteristic in the way such treatment is given in a real clinical environment. All the discussed therapies have a degree in effectiveness especially when the patient considerations and expectations are highly maintained. Stubenrauch, (2011), Spinal Manipulation Therapy for Low-Back Pain Section, American journal of nursing, 2011 Lippincott Williams & Wilkins, Inc. James Stubenrauch is a medical practitioner who also works as an editor for the American Journal of nursing, a leading journal in for medical practitioners in the USA. This is the oldest and respected evidence based academic peer reviewed article published in the Journal of Annals of internal medicine and was mainly intended for reading by their academic peers and the academic community. The journal aims at promoting health care and nursing standards through the propagation of evidence based clinical information that is of original research to the health professionals and the community. The study defines spinal manipulation therapy as any type of hands-on-treatment for the spine which includes the manipulation of the synovial joint by the application of high velocity thrust to the synovial control and mobilization. The primary outcomes of the effects of the treatment on pain are considered as the primary outcomes whereas the improvement of the patients life quality and his/her return to normalcy including the return of him/her to work will be recorded as secondary outcomes of the treatment. The authors spinal manipulation therapy has little significant to the effects of the patient’s functional status and pain relief that are short term and are not clinically relevant. The article further states that the form of manipulation therapy in efficient combination with other modes of intervention has short term significance to the patients pain relief levels and enabling the person regain his/her status of normal functionality. The article suggests that an analysis of the spinal manipulation therapy is to be done in order to evaluate and assess its cost effectiveness in addition to its benefits in the treatment of low back pain. The article is well written and analysed, with a detailed methodological section and a large addition at the end of the paper dealing with common limitations and biases when conduction this type of study. It article identifies clearly identifies the study population and how extraction of data was conducted. The article also shows how data analysis was conducted and how the results were arrived at. The study provides a high quality that Spinal manipulation therapy is statistically significant in having a reduction and eventually improving the pain level and conditions for the persons with low back chronic pain. The article however gives varying statistical evidence to indicate the short term effectiveness of the therapy. The article gives statistical prove that the SMT has limited/small significant effects that are likely to be clinical. The article proves this by giving the pain reduction scores which averaged at 4 on a standard 100-point measuring scale. The article points out that the therapy is more effective compared to the placebo mode of treatment. The therapy as recorded by the article has little and insignificant side effects and complications. LBP is a common disorder that is disabling and not only carries high medical costs that are direct to the patient but also costs that are indirect as unproductiveness of the individual. The SMT is a widely used and accepted treatment for LBP however most researches have been inconclusive of its effectiveness thus, living the practitioners and researchers on this topic with recommendations that are conflicting. 4.0. Methodology The research intends to use the primary methodology to collect its data which will involve 30 patients aging between 18 and 65 with chronic or recurrent nonspecific LBP. All the patients are to be recruited through advertisements in the social networks and the local newspapers. The respondents/participants are to be given their consent forms as per the accepted international medical research University protocols. Te research will sought to collect a larger population of the respondents before a random sampling to have the 30 required patients. The initial evaluation to have the targeted number of participants will be done through a standard chiropractic case history and a physical examination. This will be conducted in the same clinic where the radiographic equipments are available (Haldeman & Phillips 1997). The anteroposterior and lateral radiograph films which will include the lumber spine, and pelvic will be conducted in order to rule out any possibilities of congenital, inflammatory or degenerative infections or diseases that may be available in the lumbar spine. All the films are to be double checked by or under the supervision of a chiropractic radiologist. The radiological and the exclusion criteria will be spondylolysis, moderate to severe spinal osteoarithritis, inflammatory arthritis, nueromascular disease of the trunk, or spondylolisthesis. To assure that the groups are to have similar bodily characteristics in terms of sex, weight, age and height, the methodology will adopt the formation of 15 pairs of the patients where each of the members of a given pair is to be randomly allocated to one or two different groups i.e. LBP-1 and LBP-2. The treatment allocation will be blinded to the clinicians. 4.0.1. The clinical interventions The LBP-1 and LBP-2 patient groups will be assessed at different clinics that have adequate chiropractic facilities and they are not to be informed of the treatment regimes. The assessment is to be conducted by specialized chiropractors with knowledge of diversified spinal manipulation techniques. The one side posture manipulation will however be recommended for the research especially for the sacroiliac and the lumbar joints. The baseline evaluation for the two groups is to be separated for a period of 4 weeks. The period is to be used as control aimed at examining and the main pain effect time and the levels of disability. The patients are to receive a pelvic and lumbar manipulative therapy for the side posture (Haldeman & Phillips 1997). The patients are to receive a maximum of 3 chiropractic treatments in a week for the period of the study for the first phase. The LBP-2 group is to be given chiropractic treatments for the initial 12 successive treatments during the second phase of the study. The group is also to be given maintenance treatments every three weeks with an inclusion of SMT. The chiropractors are only to ask questions concerning the chief LBP palpate complaint, the pelvic region and the lumbar. The chiropractors are to ensure they exclusively manipulate these segments. The procedures are to be repeated for each visit with no patient education or complementary treatment to be given by the chiropractors to the patients at the clinic (Deyo RA et al. 1998). 5.0. Expected outcome measures The pain levels are to be assessed during the initial stages of each examination before the commencement of the treatment. The assessment is to be done daily by all the patients on the visual analogue scale (VAS). The VAS is to consist of a 100-mm scale that is continuous whose left end (VAS -0) is to refer to no pain whereas the other right end (VAS- 100) corresponds to the worst imaginable pain. The daily pain scores are to be compiled and recorded in a diary. The patients are also to be encouraged to contribute to the description of the localization and the characteristics of the pain. The diary is to be compiled and a follow up made at the end of the first phase in addition to every 3 months of the follow up period. The daily average scores for the pain are to be taken and recorded during this period (Haldeman & Phillips 1997). The 2.0 version of the Oswestry Disability index is to be utilized in the documentation of the levels of disability of the patients at both the study clinics. This is to be done before the first month preliminary evaluation of the rigorous chiropractic treatments. This is to be repeated after every 3 months of the 10 month follow up period of the study. The chiropractic questionnaire will consist of 10 articles/items that will aim at addressing different functional capacity aspects. The items on the questionnaire will have a score value ranging from 0 to 5. The higher values on the score card will represent great disability and vise versa. The total score will be multiplied by 2 and then be represented as a percentage. The disability and pain outcomes are vital as they will be able to give an understanding of how the life quality can be negatively impacted as a result of the low-back condition and thus be able to give recommendations that will realize the standardization of the outcome measurements (Cherkin et al. 2003). The patients will be given ice bags with oral and written instructions on how to use it. They are to use the ice bag any time they felt a reoccurrence of the pain episodes of and intensity that is higher than VAS 55mm out of VAS 100mm scale. They are to note these episodes in the diaries and their corresponding VAS value. These episodes when the ice bag is will have been used by the patient are to be added and compiled (Gallon 1989). The compilation is to be done on the first phase of the study treatment and followed up after every 3 month period. This is a measure to indicate the possible episodes of higher pain that the patients undergo. The descriptive analysis is to be completed by recording the total number of sick leaves the patients took and the total number of external consultations made by the patient due to LBP. This is to be noted in the diary by the patient and be compiled by the end of phase one and a follow up to be made every after 3 months (Haldeman & Phillips 1997). 6.0. The statistical analysis The 2 measures of evaluations from each group are to be a 1-way repeated variance analysis (ANOVA) in intervals. The VAS averages and the scores from the Oswestry scores from the initial and the intensive SMT for each of the followed up period are to be computed. The VAS and the Owstery scores of all the patients are to be retrieved from the 5 different interval time. The first phase and the maintenance SMT are to be evaluated by submitting them to a 2 way ANOVA dependant variable i.e Group x interval. The repeated interval is to be on the interval factor. The Gessier-Greenhouse will be applied to the freedom degrees in a sphericity assumption violation incident to decrease the possibility of changes of correlated intervals across the subjects. The number of times the patients will use the ice bag will be compiled and analyzed as well as the number of times the patient will access the services of an external consultant as a result of LBP. The records are to be submitted to the 2-way ANOVA (Group x intervals) with the repeated interval factor measures. A post hoc comparison is to be performed using the Tukey test if their will be an observation of the interval effects. The statistical analysis of all the statistical significance is to be set at p Read More