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Evidence for Clinical Practice

In patients suspected with spinal injury (P), are rigid cervical collars (I) more effective than soft collars (C) in the prevention of paralysis occurring due to spinal injury (O), Randomised Controlled Trial (T)?

Spinal injuries are one of the greatest burdens over the health care sector as it increases the chances of loss of motor and sensory functioning of the body (Uche et al., 2018). The cervical injury leads to disruption on many normal bodies functioning that lead to many secondary conditions which increase the complication of the patient (Ihalainen et al., 2017). The cervical injury is associated with a major traumatic incidence that increases the disability of the individual. The cervical injury leads to elimination of the supraspinal control of the nervous system and decreases the inhibition pathways of the parasympathetic system. The last step includes disturbance in the normal functioning of the motor and the sensory unit that lead to instability (Hagen, 2015).

Cervical collars are considered to be one of the important management aspects of the cervical injury that help in neck immobilization. It is considered to be the first-line treatment method after encountering cervical injury. The cervical columns are major of two types that include soft and rigid collars that can be used according to the patient current condition. Cervical collars are utilized to immobilize the spine during daily routine activity. The soft collar is preferred during the whiplash injury and rigid collar are preferred when the sagittal or transverse planes require more immobilization. The accuracy of both the cervical collars is still unclear due to dispute in the ideas but patient preference also plays a major role during collars selection (Barati et al., 2017). The critical review aims to identify the effectiveness of rigid collars concerning the soft collar to decrease the chances of paralysis in the spinal injured patient.

The eight that are to be included in the critical review are searched by utilizing PubMed and CINHAL by using different keywords that increase the searchability of the database. These are the two reputed databases that increase the relevancy of the article as they only have topmost publishers which first review the article before publishing the article (Bramer et al., 2017). The use of Boolean operator increases the chances to obtain more accurate data which increase the connectivity of the article with the research question (Grewal et al., 2016).

The article has utilized a different type of study that includes RCT, systemic review and literature review. The RCT and systemic review article are considered to be the high-quality data which directly help to improve the result of the study (Ahn & Kang, 2018). The study will utilize the Cochrane Risk of Bias tool to identify the studies that are to be included in the article (Jørgensen et al., 2016).

Name of author

Year of publication

Design

Participant

Intervention + comparator

Sample size

Study duration

Outcome

Aksoy, Altan & Güner

2017

Single-blind RCT

Patients who were diagnosed with clinical features of radiculopathy and imaging showing cervical disc herniation

Intervention: Use of soft collar

Comparator: Conservative treatment

N=101

12 week

Neck pain and disability in acute cervical radiculopathy was measured by the visual analog scale, Neck Disability Index and SF-36

Barati et al.

2017

Semi-experimental study design

Twenty-nine healthy participant aged 18–26 were included in the study

Intervention: Use of soft collars

Comparator:

Use of rigid collars

N=29

 

In each group, subjects were asked to perform different neck motions like extension, flexion, rotation to the left and right and lateral bending to the left and right. These data were collected using a three-dimensional motion analysis system and six infrared cameras.

Bledsoe & Carrison

2015

-

Patient with spinal injury

Intervention: Soft collars

Comparator:

Rigid collars

   

Cervical spine range of motions such as the extension to left and right, rotation to the left and right and right lateral flexion in both directions were considered.

Hood & Considine.

2017

Systematic review

The study includes spinal immobilisation in pre-hospital and emergency care settings. 

Intervention: Soft cervical collars

Comparator:

Other types

N= 47

February 2015

Immobilisation

Peck et al.

2018

Literature review

Elderly patients with spinal cord injury and spine fracture admitted in emergency care or prehospital care

Intervention: Soft collars

Comparator:

Rigid collars

N=48

 

Development of pressure sores, dysphagia and breathing difficulties

Stanton et al.

2017

Literature review

Patient with Spinal injury

Intervention: Cervical collar

Comparator:

Rigid collars and hard trauma boards

   

Findings for or against motion restriction

Sundstrøm et al.

2014

A systematic review of research papers

Trauma patients with the cervical spine and spinal cord injuries

Intervention:

Soft boards

Comparator:

Rigid collars

N=50

 

The pattern of motion with a collar

Whitcroft et al

2011

RCT

healthy subjects aged 22 to 67 years

Intervention:

Soft collar Comparator:

Rigid cervical brace

N=50

 

Neck movement was measured using a cervical range of motion goniometer. In each subject in different groups, three types of movements were checked. This included active flexion-extension, right and left lateral flexion and left and right

The first article presented by Aksoy et al. (2017) utilized the single-blind randomized controlled trial method for the study. The single-blind randomized controlled study includes a participant that does not know they belong to the control or experimental group. The blinding in the Randomized controlled trials reduces the performances biased result (Spieth et al., 2016). The sample size utilized in the study is 101 that are somehow accurate in accordance to the randomized controlled trial. The randomized controlled trial sample size can be calculated by the sample size that is usually considered to be 10% of the total population (Naidoo et al., 2020). The researchers have analyzed the patient at three periods that include before treatment, after 2 weeks and after 4 weeks. Patients were divided into three groups during the study for better analysis which was like soft cervical collars, semi-rigid and control group. The three methods are utilized during the study which includes Visual Analog Scale (VAS), Neck Disability Index (NDI) and SF-36 was applied to the subjects. The three methods applied to the study are well-recognized neck pain assessment tool and neck disability index is considered to be the simplest, common because of having with greater reliability. Visual analogy scale is one of the frequently utilized tools in clinical practise for neck pain investigation (Joseph & Palappallil, 2016). The study concluded that soft and semi-rigid collars are more effective to reduce neck pain when compared to conservative treatment.

The second study proposed by Barati et al. (2017) used the Semi-experimental study design to understand the effect of the soft and rigid collars for the spinal injured individual. The semi-experimental study design is considered to be a good method for researching as it helps to link the intervention with the outcome that is not randomly assigned. Semi-experimental study design help to measure the impact of the intervention regarding the change in the working practice (Schweizer et al., 2016). The study has utilized the 29 participants for the study which is considered to be a good sample size and they belong to 18-26 year age group all the participant are healthy. The sample size calculation for the quasi-experimental design require statistical analysis as it directly depends upon the number of the population but 30 number of the participant is considered to be the good number for the study (Maciejewski, 2018).

The researches have utilized one of the latest data collection method tools that are a three-dimensional motion analysis system and six infrared cameras which directly increase the accuracy of the result obtained. The three-dimensional motion analysis system utilizes the extracting the data by utilizing the sequential image collecting method that can help to understand the movement (Colyer et al., 2018). The studies have utilized the t-test method for the statistical analysis as t-test is considered to improve the analysis process and increase the accuracy of the result. The T-test is utilized to compare the mean between the two groups and it is widely used in the study that requires statistical analysis in regards to pain studies. It is one of the parametric analysis methods which utilize the sample that satisfies the study requirement (Kim T. K. (2015). The result presented by the study reveals that both the collars are useful to affect the neck motion but rigid collar provides a greater extent of the immobilization to reduce movement.

The third article presented by Bledsoe & Carrison (2015) is an opinion piece of study that is not considered to be high-quality research that directly hampers the quality of the study. The study is not effective to be added in the literature review section because it can hamper the quality of the result. The studies that are to be included in the literature review section needs to undergo the assessment that includes screening the quality of the studies which including understanding the research design with the methodology of the study (Paré & Kitsiou, 2017). 

The fourth article presented by Hood & Considine (2015) conducted a systemic review to understand the spinal immobilization in pre-hospital care. The systemic review is considered to be the high-quality research work and it helps to provide all the necessary information that is related to the topic. The systemic review is expected to be the gold standard to utilize the evidence according to the framework to understand the different aspect of the study (Pussegoda et al., 2017). But the study requires primary data to be included in the study and it doesn’t require the secondary data to be included in the study thus it decrease the quality of the paper. The study utilized the MEDLINE and Cochrane database to collect the article for the study and these databases provide a good quality article as the database includes a high-quality journal. Some of the good databases include MEDLINE, CINAHL and Cochrane that can be utilized to improve the quality of the paper (Li et al., 2019). The result as per the study indicates that a total of 47 studies was included in the study and out of the 15 were supportive, 13 studies neutral and 19 studies.

The fifth article Peck et al. (2015) utilized the literature review study method to understand the utilization of the spine immobilization method in elderly patient encountered with cervical spine fracture in emergency care. The literature helps to understand the different studies that are related to the topic by utilizing the different database. The accurate analysis of the study helps to identify the gap in the study that can further exploit in future research (Snyder, 2019). The researcher has utilized only the PubMed to search the article for the literature review that directly increase the chances of less accurate study to enter the review. The combination of the different database in the study helps to incorporate more reliable data to be included in the study (Bramer et al., 2017). The articles that were utilized in the study are 48 articles that are considered to be the large sample size in the literature review. The increased sample size can lead to hampering in the data analysis process and it also increases the need for the powered tool for the data analysis. The increased sample size also increases the period that is required to analyse the data that will be followed by the result prediction (Faber & Fonseca, 2014).

The article concluded that according to evidence use of spinal immobilization in the elderly patient is not common and indicate that it can be utilized for the initial management but for treatment, other methods should be used.

 The sixth study proposed by Stanton et al. (2017) analysed the importance of restricted motion in the spinal injury patient by utilizing the literature review method. The literature is considered to be the method that utilizes the evidence to identify the gap in the study that can be utilized for the study. It includes different article extracted from different databases to improve the quality of the paper (Wee & Banister, 2015). The researchers have utilized the PubMed and Cochran library for data collection by utilizing different keywords that increase the relevancy of the article that is included in the study. The database utilized for the search of the article plays an important role in the quality of the article as more renowned database provide a high-quality article. Some of the important databases that provide high-quality article by utilizing advanced search option include PubMed, MEDLINE and Cochrane (Hartling et al., 2017). The result predicted by the article state that spinal injury leads to severe health-related complication so appropriate care is required to reduce the chances of disability in individual.

The seventh study conducted by Sundstrøm et al. (2014) utilized the critical review method to understand the reconsideration time that is required to use the collars in traumatic care. The critical review helps the researcher to summarize and analyse different study to understand the different perspective of the topic concerning the study conducted (Palmatier et al., 2018). The use of a single database for data collection can hamper the study quality that is observed in this article as it only utilizes the MEDLINE database for the data collection. The high quality of study can be generated when the researcher utilizes the integration of the study obtained from a different database to generate high ended article (Karcher et al., 2018). The article has included an article that concern about the different aspect of the topic that increases the understanding of the topic. The article concluded that evidence for the use of the collar is not appropriate and document also lacks information about the harmful effect of the collars. 

The eight articles presented by Whitcroft et al. (2011) performed RCT to analyse the range of the motion that leads to neck pain by utilizing the soft and rigid collar compared with an orthosis. One of the gold standard methods that can be used to conduct the study includes RCT and it helps to identify the efficacy of the treatment. It is considered to be the superior study method that is utilized to improve patient care (Goenka et al., 2019). The study has utilized the 50 participants for the study that belong to age group 22-67 and 50 participants are considered to be the large sample size that can increase the complication of the study. Large sample size in RCT can increase the complication of the researcher so there is a need to accurately calculate the sample size by utilizing the statistical analysis tool (Ebrahim Valojerdi et al., 2017). The study predicted that soft collar and rigid brace decrease the neck movement but the cervical brace is more effective for immobilization.

The several studies that are included in the study concluded that the use of the soft or rigid collar to reduce the effective movement of the neck is observed. But the study lack of strong evidence regarding the use of the collars and still the field require further research to understand the accurate effect of the treatment over the patient. The eight articles were analysed in the critical review out of which four supported the use of the collar for the immobilization of the cervical injury patient and 4 articles lack the evidence regarding the use of the collar to reduce neck movement.

References for Evidence for Clinical Practice

Ahn, E., & Kang, H. (2018). Introduction to systematic review and meta-analysis. Korean Journal of anesthesiology, 71(2), 103–112. https://doi.org/10.4097/kjae.2018.71.2.103

Aksoy, M. K., Altan, L., & Güner, A. (2017). The effectiveness of soft and semi-rigid cervical collars on acute cervical radiculopathy. The European Research Journal, 4(1), 16-25. DOI: 10.18621/eurj.332251

Barati, K., Arazpour, M., Vameghi, R., Abdoli, A., & Farmani, F. (2017). The Effect of Soft and Rigid Cervical Collars on Head and Neck Immobilization in Healthy Subjects. Asian spine journal, 11(3), 390–395. https://doi.org/10.4184/asj.2017.11.3.390

Barati, K., Arazpour, M., Vameghi, R., Abdoli, A., & Farmani, F. (2017). The effect of soft and rigid cervical collars on head and neck immobilization in healthy subjects. Asian spine journal, 11(3), 390. DOI: 10.4184/asj.2017.11.3.390

Bledsoe, B., & Carrison, D. (2015). Why EMS should limit the use of rigid cervical collars. Journal of Emergency Medical Services, 40(2). https://www.jems.com/2015/01/26/why-ems-should-limit-use-rigid-cervical/

Bramer, W. M., Rethlefsen, M. L., Kleijnen, J., & Franco, O. H. (2017). Optimal database combinations for literature searches in systematic reviews: a prospective exploratory study. Systematic reviews, 6(245), 1-12. https://doi.org/10.1186/s13643-017-0644-y

Grewal, A., Kataria, H., & Dhawan, I. (2016). The literature search for research planning and identification of research problem. Indian journal of anaesthesia, 60(9), 635–639. https://doi.org/10.4103/0019-5049.190618

Hagen, E. M. (2015). Acute complications of spinal cord injuries. World journal of orthopedics, 6(1), 17–23. https://doi.org/10.5312/wjo.v6.i1.17

Hood, N., & Considine, J. (2015). Spinal immobilization in pre-hospital and emergency care: a systematic review of the literature. Australasian emergency nursing journal, 18(3), 118-137. http://dx.doi.org/10.1016/j.aenj.2015.03.003 1574-6267

Ihalainen, T., Rinta-Kiikka, I., Luoto, T. (2017). Traumatic cervical spinal cord injury: a prospective clinical study of laryngeal penetration and aspiration. Spinal Cord 55, 979–984 https://doi.org/10.1038/sc.2017.71

Jørgensen, L., Paludan-Müller, A.S., Laursen, D.R.T., Boutron, I., Sterne, J. A. C., Higgins, J. P. T. & Hrobjartsson, A. (2016). Evaluation of the Cochrane tool for assessing the risk of bias in randomized clinical trials: an overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews. Syst Rev, 5(80), 1-13. https://doi.org/10.1186/s13643-016-0259-8

Joseph, L. R. & Palappallil, D. S. (2016). Neck disability index, Visual analog scale, and Likert scale in patients receiving pharmacotherapy for neck pain: How well do they correlate?  

Naidoo, N., Nguyen, V.T., Ravaud, P. (2020). The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med 18(6), 1-11. https://doi.org/10.1186/s12916-019-1476-5

Peck, G. E., Shipway, D. J. H., Tsang, K., & Fertleman, M. (2018). Cervical spine immobilisation in the elderly: a literature review. British journal of neurosurgery, 32(3), 286-290. https://doi.org/10.1080/02688697.2018.1445828

Spieth, P. M., Kubasch, A. S., Penzlin, A. I., Illigens, B. M., Barlinn, K., & Siepmann, T. (2016). Randomized controlled trials - a matter of design. Neuropsychiatric disease and treatment, 12, 1341–1349. https://doi.org/10.2147/NDT.S101938

Stanton, D., Hardcastle, T., Muhlbauer, D., & Van Zyl, D. (2017). Cervical collars and immobilisation: a South African best practice recommendation. African Journal of Emergency Medicine, 7(1), 4-8. DOI: 10.1016/j.afjem.2017.01.007

Sundstrøm, T., Asbjørnsen, H., Habiba, S., Sunde, G. A., & Wester, K. (2014). Prehospital use of cervical collars in trauma patients: a critical review. Journal of neurotrauma, 31(6), 531-540. DOI: 10.1089/neu.2013.3094

Uche, E. O., Nwankwo, O. E., Okorie, E. & Nnezianya, I. (2015). Cervical Spine Injury: A ten-year multicenter analysis of the evolution of care and risk factors for poor outcome in southeast Nigeria. Niger. Journal of Clinical Practice, 18, 203-208

Whitcroft, K. L., Massouh, L., Amirfeyz, R., & Bannister, G. C. (2011). A comparison of neck movement in the soft cervical collar and rigid cervical brace in healthy subjects. Journal of manipulative and physiological therapeutics, 34(2), 119-122. DOI: 10.1089/neu.2013.309

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