Essay On Consort Evaluation Assignment

The title of the study is ‘Immediate Effects of Region-Specific and Non-Region-Specific Spinal Manipulative Therapy in Patients With Chronic Low Back Pain: A Randomized Controlled Trial’ which is properly indexed since the word ‘randomized’ is explicitly used by the authors. The abstract provided in the study was almost complete. The study was conducted by Ronaldo Fernando de Oliveira, Richard Eloin Liebano, Luciola Menezes Costa, Livia Rissato, and Leonardo Pena Costa. The participants were 148 patients with chronic nonspecific low back pain. The intervention employed in the study was a “single high-velocity manipulation to upper thoracic region of the participants assigned to the non-region specific manipulation group and to the painful lumbar levels of participants assigned to the region-specific manipulation group” (Oliveira, Liebano, Costa, Rissato & Costa, 2013, p. 1). The authors provided specific objectives which were to analyze the effects of a single, region specific spinal manipulation defined during the clinical manipulation and to compare the effects of the interventions given to the participants. The researchers gave the outcome of their study which resulted to the improved health condition of the two groups involved and that no adverse reactions were observed. The researchers were able to come up with a comprehensive abstract that included most of the criteria of the consort. An accurately written abstract is very important for selling the author’s work especially in the journal form (Gill, 2012).

Background

The study was done to improve the health condition of patients who have a chronic lower back pain which causes absenteeism, work disability and costs. Because of the impact of chronic lower back pain there where treatments proposed by European guideline and one of them is the spinal manipulative therapy (SMT). There were a large number of evidence on nonbiomedical effects of SMT in people who are healthy and those with symptoms of low back pain. It is now recognized that spinal manipulation increases pain tolerance and pain threshold. However, the studies published about the SMT were only performed in healthy people; hence, a need for a study on people who have chronic low back pain with region specific and non-region specific effects of SMT.

Method

The method used in this study is a “2 –arm randomized controlled trial with a blinded assessor was done” (Oliveira et al., 2013, p. 2). The researchers included patients who were seeking physical therapy treatment for chronic low pain and those who were enlisted from the community with chronic low back pain. This study was conducted in the Physical Therapy Department of the city of San Antonio de Aracangua, Brazil. After their first assessment the participants were given the anamnesis and clinical examination.
Oliveira et al., said that “the therapist opened a randomization envelope saying whether the vertebral level should be manipulated” (2013, p.3). The randomization codes were placed in consecutively numbered, sealed, opaque envelopes which ensure the concealed allocation of participants to groups.
Consequently, Oliveira et al., explained “the participants placed to the non-region-specific manipulation group, received a single, ‘global’ high-velocity manipulation at the upper thoracic between T1 and T5 levels” (2013, p.3). If they are placed to the region specific manipulation group, the participants were controlled between L2 and L5 according to the therapist’s clinical examination.
According to Oliveira et al., “the assessor was blinded to the treatment allocation and performed an assessment before and after the intervention” (2013, p. 3). The assessor, after the clinical outcomes wrote the patient’s chart which types of manipulation the assessor thought the patient experienced. Then, the codes were compared with the randomization codes.
The sample size was calculated using a priori to find out the difference of 1.0 point for pain intensity as measured with the numeric pain rating scale. A statistical power of 80%, alpha of 0.05% and sample loss to follow up of 15% were considered; thus, 74 patients were needed per group comprising a total of 148 participants.
The study was not able to present biases since the researchers used a randomized controlled trial. According to Blackwell Publishing (2015), RCTs are vulnerable to various types of biases throughout their entire life span. Though they might not have encountered biases in the study they should have reported it in the journal.

Results

The participants of the study were mainly females and with long term symptoms of lumbar pains. According to Oliveira et al., “both groups improved in terms of pain intensity within a group difference of 1.91 points o 95% in the region specific group and non-region specific group” (2013, p. 5). Oliveira et al., elucidated that “there were no changes in PPT for region specific manipulation group” (2013, p. 5). In addition, Oliveira et al., the researchers also observed “a positive and moderate correlation between changes in PPT at lumbar levels and changes in PPT at tibialis anterior muscle level” (2013, p. 5). The trial flow started from recruitment which assessed the participants, allocation, treatment, and analysis.

Discussion

There was a first- class procedural evidence that supports the use of SMT in the treatment of patients with prolonged lumbar pains. It is also recommended by clinical practices guidelines for other muscle and skeletal illnesses. Oliveira et al., also found out that “non-specific region manipulation is just as effective as region-specific manipulation” (2013, p. 4). The researchers discovered that the reduced intensity pain can be attributed to the spinal, supraspinal and or even nonspecific mechanisms that can mediate pain.
Although the researchers explained that they had done everything to reduce the emergence of bias such equal randomization, blinding, concealed allocation, similarity in baseline, sample-size calculation, and intention to treat analysis method, still limitations surfaced during the study. The researchers were right to employ equal randomization because it eliminates confounding which tends to create groups that are comparable for all factors that affect outcome, known, unknown, or difficult to measure; thus, the only difference between the two groups is the intervention (healthknowledge.org., 2015). Another limitation of the study was that the assessors were not feasible to be blinded in trials with active treatment interventions. Another limitation of the study is the inclusion of mixed participants who were seeking for low back pain and patients from community, the lack of a placebo or non-treatment group and a selection of patients with long standing pain. According to Torgerson (2015) to achieve better results in blinding the ‘gold standards’ in health care trials should be double blind placebo controlled trial. This should have been done by the researchers.

References

Blackwell Publishing (2015). Bias randomized control trials. Retrieved from
http://www.blackwellpublishing.com/content/BPL_Images/Content_store/Sample_chapter/9781405132664/9781405132664_4_003.pdf
de Oliveira, R. F., Liebano, R. E., Costa, L. d. C. M., Rissato, L. L., & Costa, L. O. P. (2013).
Immediate effects of region-specific and non-region-specific spinal manipulative therapy in patients with chronic low back pain: A randomized controlled trial. Physical Therapy, 93(6), 748-756. doi: 10.2522/ptj.20120256
Gill, P. (2012). The importance of abstracts and press releases: The issue of ‘spin’. Retrieved
Health Knowledge Organization. (2015). Design, applications, strengths and weaknesses of
interventions studies and randomizes controlled trials. Retrieved from
http://www.healthknowledge.org.uk/public-health-textbook/research-methods/1a-epidemiology/cs-as-is/intervention-studies-rct
Torgerson, D. (2015). Sources of bias in RCTs. Retrieved from
http://www.tlrp.org/rcbn/capacity/Activities/Themes/Expertise/Design/darct%20blinding%2029.9.04.ppt