The Effect of Manipulation on Low Back Pain Treatment - Research Proposal Example

The Effect of Manipulation on Low Back Pain Treatment xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Name xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Institution xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Lecturer xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Date Abstract There has been contradictory reports on the effectiveness of manipulation of low back pain treatment. While some researchers conclude that its effectiveness is superior, others indicate that manipulation of low back pain treatment is as effective as other applied therapies. Bearing in mind the high prevalence and incidence rate of low back pain, the developed research questions and objectives intend to find out whether manipulation of low back pain treatment is effective, the level of knowledge regarding manipulation techniques and whether attached benefits outweigh the risks. This paper proposes the application of targeted sampling whereby 30 participants will be recruited as the study sample. 15 of them will be the control group and the other 15 the actual group. Double blind method will be applied in reducing researcher and participant bias. In collecting relevant data, a questionnaire will be applied and the data will be collected within a three months period. Definition of Terms Low back pain: This is predominate musculoskeletal pain that affects the back along the spine (Assendelft et al. 2003). The symptoms range from acute to chronic. Disorders and diseases are the variety causes. Low back pains mainly results from the injury to the inter-vertebral discs (disc tears or disc herniation) or injury or tear of the ligaments in the back. The pain can be felt in the thighs back parts, buttocks, and the lower back in general following sciatic nerve pain (Bronfort et al. 2008) Spinal Manipulation- is a therapeutic intervention that is monitored by the health practioner such as the convectional medical doctors, osteopaths, physical therapists and chiropractors (Bronfort et al. 2008). Spinal manipulation involves the application of controlled force to the affected back areas and moving the joints beyond their normal (passive) ranges of motion. Controlled force is applied either by hand or a device is targeted to a spine column. Forces being applied will vary depending on the type of or form of manipulation being used. The role of the therapy is the management of pain as well as improving the physical functioning capabilities of the patients. Spinal manipulation is mainly carried out at the spinal joints that have synovial joints due to them being easily manipulated. Synovial joints would include the lumbosacral, sacroiliac, costotransverse and costoverterbral joints (Assendelft et al. 2003). Risk Factors- these are the accelerators or predisposing factors of the low back pain (Dagenais 2010). Pain-is an emotional and unpleasant sensory experience which related to either potential or tissue damage and motivates someone to move away from the scene or incidence of pain production (Assendelft et al. 2003). Terminology Manipulation has other synonyms such as adjustment of the spinal joint, Grade V mobilization or HVLAT (High Velocity low amplitude thrust) (Bronfort et al. 2004). 1.0. Research questions According to Van et al (2004), 75% to 85% of workers’ absenteeism form their places of work is attributed to chronic and recurrent pain. This translates to lowered production capacity in any organization and hence lowered profits. Since 2% to 7% of those experiencing acute low back pain develop chronic pain, it is very essential that relevant and effective measures to reduce the incidence and prevalence rate of low back pain be researched on. Worse still, disabilities resulting from chronic low back pain has increased by over 1000% hence being termed as a 21st century epidemic (Waddell 1984). Past researches indicate that manipulation of low back pain treatment has been effective in reducing the time taken to recover from low back pain (Thomas and While 2001). To determine the accuracy of this results, the following research question will be applied 1. Does the time taken to recover from low back pain reduce with manipulation of low back pain treatment? 2. Does the effectiveness of manipulating low back pain treatment outweigh the risks involved? 3. Are health providers aware of the low back pain treatment manipulation techniques? 2.0. Literature review 2.1. History of SM Spinal manipulation has been practiced since time immemorial by traditional practioner in different cultures. Hippocrates and Egyptians used manipulative technique as were other cultures. With introduction of chiropractic and osteopathic medicine in 1980s more emphasizes was put on manipulative therapy in North America (Dagenais 2010). 2.2. Modern Providers Currently SM is being provided by convectional medical doctors, osteopaths, physicians, physical therapists and chiropractors in North America and parts of Europe countries (Dagenais 2010). 2.3. Mechanisms of Spinal Manipulation Spinal Manipulation uses biomechanics of kinematics and kinetics and this makes it different from other manual therapy. Kinetically, three phases are applied: resolution phase. Thrust and pre-thrust phase. Spinal manipulation will thus have the following effects which include relief of musculoskeletal pain temporarily, increase in the passive motion range and an alteration of the sensorimotor integration (Ferreira et al. 2007) 2.4. Clinical Implications of Spinal Manipulation Since the application of manipulation in health sector it has shown to have reduced the time taken towards back pain recovery, musculoskeletal pain is temporarily relieved, sacroiliac joint is not altered in position (Assendelft et al. 2003). Some minor side effects such as radiating discomfort, tiredness, headache and local discomforts are experienced during spinal manipulation (Dagenais 2010). 2.4.1. Effectiveness According to a systematic review carried out in 2010 comparing spinal manipulation (SM) with other therapies its effectiveness is of equivalent or more superior (Bronfort et al. 2004). A meta-analysis performed by Bronfort indicated the effectiveness of spinal manipulation in that those receiving it were 54-84% better of when compared with patients receiving similar treatment without spinal manipulation. Other therapies include exercises, physical therapy and pain relief drugs. The American pain society in conjunction with the American college of physician in 2007 together recommended SM to be used by the clinicians on the patients whose response to self care was not positive. Other reviews carried in 2006 and 2008 showed that the SM was just equivalent to other therapies in management of low back pains. Better response was observed among the patients used spinal manipulation in the management of low back pain (Bronfort et al. 2008). 2.4.2. Safety Just like any other therapy spinal stimulation has its own risks though serious ones are not common (Ferreira et al. 2007). These include cauda equine syndrome, rib fracture, vertebral fracture, spinal disc herniation, death and stroke. Minor ailments include tiredness, headache or discomfort in the region where SM was applied. These minor side effects disappear within a day or two. The complications that could result from spinal manipulation such as cauda aquina syndrome are rare and hence management of low back pain via spinal manipulation procedure is therefore considered safe in the management. 2.4.3. Challenges facing researchers Previous studies and findings have quite differed in their findings and this still leaves behind a question of whether the results acquired following the use of spinal manipulation are reliable or not. Efficacy of the entire process has time and again been put to question as to whether the entire process is worth being relevant in the management of low back pains (Bronfort et al. 2004). This particular research is aimed at resolving any discrepancies that are related to the use of spinal manipulation therapy in the management of low back pain. Establishment of the effectiveness as well as treatment effects of manipulative therapy in the management of low back pain will also be determined by the research. Objectives: To evaluate effectiveness of spinal manipulation in managing low-back pain To identify specific treatment effects of spinal manipulation in the management of low-back pain To determine if there are any discrepancies related to spinal manipulation of low back pain 3.0. Research methodology 3.1. Sampling procedure Targeted sampling will be applied in selecting participants who will attend physiotherapy practice in a healthcare centre for at least three months. This is because only those attending physiotherapy practice have the relevant information. No participant will be forced into participating. This will be enhanced through the use of an informed consent form which participants must sign before being recruited into the process. The exclusion and inclusion criteria’s will be followed to the mark to get the desired population which will undergo the study. This will be done by establishing the causes of the low back pains as well as the location of the back pains within the patients. Those who will have an ongoing pathology affecting the spinal column or having the location of the back pains not in the low back shall be excluded from the study. Those who will have the pains located in the lower back and have no pathology associated with the low back pain will be included in the study and will now form the study population. Inclusion criteria will also be based on participants having to attend physiotherapy practice for three months and above. This will reduce the cost involved since it will be conducted parallel to the weekly visits. Those below the age of 15 and above the age of 20 years will be excluded from the study due to the assumption that the old and young children are likely to give inconsistent information and their defaulter rate is likely to be high. In the inclusion criteria, the sample will include 30 patients who had acute mechanical low back pains. The patients will be males and females aged between 15-20years. This is because the effect of manipulation in low back pain treatment may vary based on patient’s gender. The pain that patients will be having has to be located in the areas between the gluteal regions up to the level of Thoracic vertebra number 12. On the other hand, the exclusion criteria will be based on the causes of the low back pains in the patients. Patients who will have diabetes, tuberculosis, Paget’s disease, osteomyelitis, arthritis, neoplastic diseases, osteoporosis and those who were under anticoagulant medication as well as previous lumbar spine injuries will also be excluded from the study and will not be allowed to participate. This is based on the assumption that low back pain may be resulting from other complications. Exclusion will also be considered to the patients who have not consented to participate in the study. Such patients will be ruled out and not allowed to be in the research population. In this study there will be two groups for comparison purposes and to establish the efficacy of spinal manipulation in the management of low back pains. As a result, a control group with similar characteristic will be involved. In this regard, a placebo will be given to the control group to make them believe that they are receiving similar treatments. This will be important in determining whether manipulation of low back treatment reduces the time taken to reduce this pain (Burton et al 2000). The control group will undergo low back pain without any form of manipulation. Inclusive population will have to undergo randomization process. Randomization will be achieved through tossing/flipping of a coin that will result in the formation of group 1 that will comprise of fifteen participants and group two which shall have 15 participants. Pain will be managed in group one by manipulation therapy whilst in group two low back pain was managed through exercise program (massage). The second group is the control group but this will not be made known to the group members or researcher assistants. This means a double blind method will be applied during the collection and analysis of data. The main aim is to reduce biases that would result from the participants or researchers knowing the control group. When participants know that they are being used as a control group there are likely to change their behavior and this would affect the final results. 3.2. Assessment Assessment will be conducted by independent examiners who will be blinded to the two groups that will be available. The outcome measures will then be recorded. Outcomes to be measured and recorded included the measurement of pain by the absolute analogue scale which recorded the intensity of pain in numerical figures. Disability shall also be assessed by the use of Rolland Morrison disability index. What happens to the body during spinal manipulation therapy procedure, various complications as well as side effects of manipulation therapy will also be recorded when they occurred. Measurements and observations will all be taken at the same time in all patients who were undertaking the research study. Participating patients measurements will be taken as well as evaluation conducted from initial assessment and subsequent treatment which will be carried out at the end of every week approximately at the same time(e.g. between 2pm and 3pm) . Patients will have to attend 8 treatment schedules, twice weekly. Post treatment assessment will also be conducted weekly for a period of four weeks after the patients have stopped manipulation therapy as well as other methods (exercises) used in the management of lower back pain (Cherkin et al 2003). 3.2.1. Assessment procedure: Intervention and patient treatment: Manipulation therapy will be performed either at level Lumbar vertebra1-Lumbar vertebra 5 or from level Lumbar vertebra number 5 up to the sacral vertebra number 1 of the vertebra. On the other hand for the second group, exercises shall be carried out and they will commence with the patients undertaking hands knee position while gradually progressing to a standing position with the lumbar region assuming a neutral position and enhanced by the use of a pelvic stabilizer (Cherkin et al 2003). 3.3. Ethical considerations Names of the participants will not be used when conducting the study. This is to ensure that privacy of collected information is maintained. In addition, this will reduce researcher bias that are likely to emerge during data analysis, interpretation and recording. The two groups will be group A (for the actual group) and group B (for the control group). Group B will not receive the manipulation though it might have been helpful in reducing the time taken to relieve a patient of low back pain. However, it is unethical that patients be denied the relevant treatment if it would be of more advantage to them (Vlaeyen 2000). Participants will only be allowed to participate when they have signed a consent form and given a go ahead (Dickson-Swift et al 2008). Participants are also to choose the method they desire in the management of low back pain and they will not be forced into a method they do not want to engage in. patients who are participating will be treated with dignity and respect they deserve by the staff and the other management team and their needs and wishes will be respected during the study period. This will be enhanced by ensuring that they continue to receive service in the normal environment as before. Family members of the patients who are participating will also be informed of the entire process that will be carried out and also requested to provide assistance while the study is being conducted that is on the occasions which their help will be required such as how to care for the patient when out of the research facility (Powell 2011). 3.4. Project timetable Phases of the project Date of commencing Date to be finished Ethical approval 7/8/2011 8/8/2011 Literature review 8/8/2011 9/8/2011 Recruitment and purchase of equipment and machines to be used 7/8/2011 7/8/2011 Data collection 10/8/2011 10/10/2011 Data processing 11/10/2011 23/11/2011 Data presentation 24/11/2011 24/11/2011 3.5. Problems likely to be encountered while conducting the study: 3.5.1. Recruitment exercise Recruited staff that is responsible in the performance of spinal manipulation therapy should be individuals who have knowledge on how to carry out clinical assessments of the patients. They should also be able to have functional knowledge of anatomy, biomechanics, physiology, disease process, pathology as well as tissue healing when performing spinal manipulation therapy. Getting the right staff to be involved in the study could be a task since they have to be specially trained in the matters of the management of pain. This would allow for effective coordination as well as conducting the process of pain management. Getting the right staff for the job would thus become an uphill task. In order to avert this problem, recruitment in this case should be done on the basis of merit as this will ensure that the participants will be handled in the desired way and at the end of the day purpose of the research will be achieved. 3.5.2. Time management: The entire study is to be conducted bearing in mind time intervals at which the various recordings of measurements as well as evaluations of the patents are to be done. Patients and the workers therefore had to report to the site of the study at the specified time. The entire process was also to keep in line with the schedule and only perform therapies on the specified day. This problem can be overcomed by coming up with an events schedule which will clearly show the time as well as the events which are to be carried out and who will be carrying out that particular event. Adequate utilization of the set time to carry out the research within the allocated time intervals will thus be enhanced. 3.5.3. Migrations, defaults or deaths Some clients could have to move from the area of study, deaths as well as patients who default the treatment process would have a major setback to the research. A high defaulter rate resulting from patient’s failure to attend the last sessions is also likely to be experienced since the study will be conducted over a period of time (3 months). Participants may also migrated to ad different location thus seeking for the services elsewhere. If this happens on a large scale, the research would be a sham since the sample to be studied will not provide the desired outcome or purpose of the study and more money set in the budget for the research will be put to waste. This problem will be avoided by ensuring that only those participants that are not to move or migrate form that locality or are unlikely to default the treatment are allowed to be involved in the study. In addition, patients will be made to understand the importance of completing their treatment schedule. 3.5.4. Financial limitations When conducting the study, the finances could be depleted even before the entire study process has been completed. This will put strain on the available resources and hence the study will not be efficient due to compromised results being realized or achieved. Financial limitations can be avoided with the formation of the budget for the research which will be able to cater for the goods as well as services that will be required while conducting the entire study. Budgets will ensure that all needs are taken care of by the available funds. An efficient budget will thus enable the realization of the intended purpose of the study. The budget will also reduce since this research will be conducted during normal visits made by patients experiencing low back pain. This means that equipments and the space required is already available in the healthcare centers. In addition, the service providers will collect relevant measurements while the researcher and research assistance collect any other information. This will reduce the number of interviewers being involved in the study. 3.5.5. Faulty equipment and machines While conducting the study, the equipment and machines to be used may cease functioning either through breakage or some parts might be misplaced. Faulty equipment and machines will lead to the efficiency of the study to be reduced since the machines and equipment will now have to be shared by some of the patients and this will greatly affect the getting of the desired results of the study since evaluation and the therapy itself has to be conducted within the stipulated time. To avoid this problem, purchasing of the equipment and machines has to be done with the verification of their working conditions. Records should also be kept about who is using a particular machine or equipment to avoid misplacement of the equipment or loss through fraudulent means (Bronfort et al. 2004) 3.5.6. Resources required in the study: Finance Funds will be vital in the purchasing of goods such as the equipment to be used while conducting the study and in the acquisition of services which will be provided by the staff. The premises Or place the research will be conducted will also be leased and this will require money for the payment of rent. Summary of estimated cost of the entire project Goods or services to be purchased quantity cost per item total stationary: files 40 2$ 80$ rims of paper 6 5$ 30$ pens 120 1$ 120$ paper punch machine 15 6$ 80$ rulers 32 1$ 32$ graph papers 120 1$ 120$ erasers 32 1$ 32$ spinal manipulation equipment: spinal massager or pelvic corrector 32 N/A provided by the health facility imaging equipment; computed topographic machines 5 N/A provided by the health facility X-ray machines 5 N/A provided by the health facility magnetic resonance imaging 5 N/A provided by the health facility coaches 30 N/A provided by the health facility wheel chairs 32 N/A provided by the health facility vans 3 N/A provided by the health facility staff: subordinate staff: drivers 3 2500$ per month 7,500$ cleaners 5 1500$ per month 7,500$ security guards 3 2000$ per month 6,000$ senior staff: Therapists 15 500$in every session(12session in the study) 90,000$ physicians 5 500$ in every session(12 sessions in the study) 30,000$ statitians 5 4000$ per month(for the three months) 60,000$ Total cost of the study= 201,494$ 3.5.6.1. Time For the success of the study to be realized, there is dire need to make adequate use of the time that is allocated for the study. The entire study should be carried out within an ample time frame work which will enable credible results that are desired from the study being achieved. Time will be linked with the activities that are to be carried out and this will be enabled through the formation of a schedule of activities. The time schedule will include the activities from the beginning of the study that is on 7/8/2011 till 24/11/2011 when the study will be completed. Timing of when the evaluation as well as appointments will also be adhered to during this period will be done between 2 and 3pm in every day of the study. 3.5.6.2. Transport Movement of staff as well as the participating patients will be enhanced by the use of vans which will be purchased. Transportation of materials and tools to be used when conducting the study will also is enhanced by the presence of the vans. In addition to the vans, there will also be the need to purchase wheel chairs to facilitate movement of the patients within the premises where the research is being conducted. 3.5.6.3. Equipment and machines There will be need to purchase various equipment which will be used in the study. This equipment will include stationary which will include stationary materials in which the research will be recorded in rims of paper, files to keep the records, pens and erasers. Equipment to be used in the therapy would include the spinal massager or pelvic corrector. X-ray equipment, computerized tomography scans, magnetic resonance imaging equipment will be used in monitoring and evaluation of the patients during the entire study period. 3.5.6.4. Staff The staff to be recruited in the study will range from the support staff to those who are skilled. Support staff would include drivers, cleaners, messengers and security. Skilled staff will include, physicians, osteopaths, physiotherapists who will be in charge of the provision of the management of the back pains to the patients. However, these staff members are already employed in the health centers thus reducing the total cost of conducting the research. Other skilled personnel will include the statisticians and other data entry officials who will be in charge of the handling of the data that has been obtained and processing it in order to come up with the logical conclusion of the study (Assendelft et al 2003). These will be paid upon completion of data recording and analysis. References Assendelft WJ. et al. 2003. Spinal manipulation of low back pain. Annals of internal medicine. 138(11):871-881. Assendelft, W, J, Morton, S, C, Yu, E, I., 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. 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