Introduction
Chronic low back pain (LBP) is a common issue accompanied by pain, limited physical activity, fear of movement, disability and low quality of life. Although a number of works highlight this issue and possibly efficient treatment, some papers are irrelevant, invalid, and lack a sufficient evidentiary basis. This paper aims to critically appraise the article titled “Comparison of the effectiveness of an e-health program versus a home rehabilitation program in patients with chronic low back pain: A double blind randomized controlled trial” written by Lara-Palomo et al. (2022). The authors proposed simultaneously performing McKenzie exercises and applying transcutaneous electrical nerve stimulation (TENS) for patients with chronic LBP. The investigators carried out a randomised controlled trial to explore health outcomes based on the suggested treatment. The primary purpose of the research was to compare the effectiveness of such treatment via a digital health program versus a home rehabilitation program.
Critical appraisal of an article implies an assessment of credibility, relevance, research methods, and interpretation of results, as well as evaluation of conclusions, findings and value to the practice. The Critical Appraisal Skills Programme (CASP) tool is used to assess the selected article and guide through the process of article critique (CASP, 2020). The CASP critiquing framework allows identifying strengths and weaknesses of the research, apprising validity, results and findings’ implementation to practice.
Issue
The researchers aim to create an appropriate rehabilitation program for patients with chronic LBP that may be applied in unsupervised in-home settings supported by a digital health system. The authors’ intervention consists of electroanalgesia and McKenzie therapy, based on digital health application or the same treatment supported with ordinary printed instructions. Lara-Palomo et al. (2022) support their selection of exercises with the statement that the “McKenzie Method is a widely-used, comprehensive approach to chronic LBP that includes both an evaluation and intervention component” (p. 2). Moreover, the investigation of Mbada et al. (2019) provides evidence that the results of the McKenzie exercises program performed with the help of telerehabilitation are comparable to the traditional supervised McKenzie therapy. Regarding the electroanalgesia method’s selection, the study of Facci et al. (2011) describes that TENS application contributes to decreasing pain and improving disability in patients with LBP. Both therapies have shown their efficiency though rarely applied simultaneously, especially within digital health systems.
The current PICO question applied to the study is the following: in patients with chronic LBP performing McKenzie exercises accompanied by TENS application (P), does support by e-health program (I), compared to home rehabilitation program (C), efficiently contribute to managing pain, disability, functionality, fear of movement and quality of life (O)? Therefore, the core research question relates to discovering the impact of e-health program versus home rehabilitation on improving the pain and well-being of patients with chronic LBP.
Randomisation and Blinding
In the current research, patients were randomly allocated to follow e-health or home rehabilitation program via a digitally generated randomised table before the initial data collection. The process was conducted by an investigator “not involved in either recruitment or treatment” (Lara-Palomo, 2022, p. 3). According to the CASP (2020) checklist, randomisation was carried out in a relevant manner: the selected method was appropriate, and randomisation was sufficient for systematic bias avoidance. The blinding was also reasonable: the allocation sequence was concealed from participants and investigators, and blinded therapists assessed patients. Double-blind trials avert bias when practitioners evaluate patients’ health outcomes. Such an approach improves the credibility and reliability of research results.
Sample Size
The final sample included 74 participants aged between 30 and 67 years suffering from non-specific chronic LBP and having a disability score of 4 or above on the Roland Morris Disability Questionaire (RMQ). The estimated sample size was justified by relying on Willan’s (2001) determinations for beneficial, robust, cost-effective and statistically significant samples. Initially, there were 270 prospective participants, but only 80 met the inclusion criteria, of which six were dropped out due to loss of follow-up.
Methods
The current study’s design is a double-blind, randomised, controlled comparative trial with a follow-up period of six months. Prospective participants were interviewed by telephone and went through face-to-face screening to ensure meeting the inclusion criteria. Before participation in the research, the included patients provided written informed consent. In accordance with the CASP (2020) checklist, the study was methodologically sound. The study data was collected “before the first treatment session (baseline) and immediately after the final treatment session by a physical therapist blinded to the patient’s treatment allocation” (Lara-Palomo et al., 2022, p. 4). Participants provided demographic and health information and completed several questionnaires and tests. The researchers evaluated adherence to treatment by relying on dairy entries or the number of logins with time spent online, depending on home rehabilitation or e-health group, respectively.
The assessor of the outcomes and the statistician were blinded, which increased the reliability of the study. Lara-Palomo et al. (2022) state that “the outcome assessor was not involved in the treatment”, and the data processed by the statistician “did not contain any information identifying patients as belonging to either group” (p. 4). The baseline characteristics of both groups were set out, and there were no differences between groups that could affect the research outcomes. Groups were treated equally: each group of participants received the same level of care apart from the experimental intervention. The McKenzie exercise program was individually planned before randomisation; participants were divided into three subgroups according to the McKenzie classification.
Both home rehabilitation and e-health groups performed 24 treatment sessions over two months. The first group was taught how to perform their exercises and use a portable TENS device during the first session with the therapist and carried out subsequent sessions unsupervised with the help of written instructions. The second group accessed an internet-based healthcare website that provided participants with videos accompanied by audio instructions and explanatory images.
Results
The investigators conducted a substantial statistical analysis of the study results and provided a comprehensive interpretation of the outcomes measured. Lara-Palomo et al. (2022) conducted an intention-to-treat analysis examining the study results by including all randomised participants in the statistical analysis. This approach allowed the investigators to draw unbiased and accurate conclusions regarding the treatment efficiency. The results section of the article was critically appraised following the CASP (2020) checklist. It can be concluded that the effects of the intervention were reported comprehensively, the precision of the estimate of the treatment effect was reported, and the benefits of the intervention outweighed the harms and costs.
The power calculation was undertaken supported by statistical tests and reported p values. The authors reported that all data were analysed using the SPSS software platform, “using intention-to-treat analysis” (Lara-Palomo et al., 2022, p. 6). The data were tested for normality with the help of the Kolmogorov-Smirnov test. The independent samples Student’s t-test was applied to compare the treatment efficiency between the e-health group and the home rehabilitation group. The investigators used the paired t-test to compare baseline and post-treatment variables in each group. The confidence interval was reported: it “was established at 95%, and the significance level at 0.05” (Lara-Palomo et al., 2022, p. 6). The study included testing of effect size with the help of Cohen’s d and pointed out indicators of effect size difference’s significance.
The measured outcomes were clearly specified: the authors compared baseline and post-treatment scores for a number of questionnaires and tests. They analysed results in the Roland Morris Disability Questionnaire, the SF- 36 Health Questionnaire, the Oswestry Disability Index, the Visual Analog Scale, the Tampa Scale for Kinesiophobia, the McQuade test and the Fingertip-to-Floor Distance test. The dimensions of the SF-36 were measured separately as Physical function, Physical role, Bodily pain, General Health, Vitality, Social functioning, Emotional role and Mental health. The investigators highlighted that the main outcome measure was the change in the RMQ score.
The results for each measured outcome in both study groups were reported, clearly presented in tables, described and interpreted. Lara-Palomo et al. (2022) concluded that patients from the e-health group “showed significantly greater improvement than those who followed the Home rehabilitation program in most outcomes” (p. 6). Nonetheless, the authors highlighted that both groups “improved significantly in the immediate post-treatment follow-up compared with baseline scores” (Lara-Palomo et al., 2022, p. 6). The investigators emphasised that Student’s t-test showed several outcome measures had statistically significant differences between the e-health and home rehabilitation group. Those outcomes were: disability, the intensity of pain, lumbar flexion mobility (p < 0.001), physical role, physical function, mental health, emotional role, vitality and social functioning (p < 0.005) (Lara-Palomo et al., 2022, p. 6). Moreover, the researchers reported that participants in both groups “experienced similar improvements in fear of movement and isometric resistance of abdominal muscles”, and the t-test showed no significant difference between the groups (Lara-Palomo et al., 2022, p. 7). The data provided by the authors are substantial, reliable, and adequately analysed.
The results of the Student’s t-test coincide with the indicators of Cohen’s d of the effect size. The study results showed that the suggested rehabilitation program with online support resulted in more significant improvements in pain, physical function, disability, mental health and vitality compared to the program without online support (Cohen’s d ≥0.8) (Lara-Palomo et al., 2022, p. 9). Nevertheless, core findings remain noteworthy: both groups achieved significant results and health improvements after the intervention. Suggested treatment in both groups was beneficial and cost-effective considering the home settings and self-care approach. The article does not contain any missing or incomplete data, and no potential sources of bias are identified. Differential drop-out between the two research groups that could distort the study results was not detected.
The study offers an unaccustomed but impressive treatment option implying simultaneous usage of McKenzie therapy and TENS supported by e-health technologies in patients with chronic LBP. Lara-Palomo et al. (2022) assume that “the support of an online platform during the home program increased patient motivation and interest in the intervention” (p. 9). Obtained results prove the efficiency of the suggested rehabilitation program and, therefore, its applicability to practice. The only drawback of the study is its short conduction period: to increase the credibility of the results, more extensive long-term investigations are required.
Funding
This work was funded by a research grant from the Carlos III Health Institute and three grants from the Andalusian Health Service, Junta de Andalucía. The authors state that the funders “did not take part in the design of the study, its implementation, analysis, data interpretation and/or the presentation of results” (Lara-Palomo et al., 2022, p. 9). Thus, the funders did not affect the study’s results and outcomes, and there were no biases associated with funding.
Conclusion
The current research was critically appraised, every section was evaluated using the CASP checklist for randomised controlled trials, and the subsequent conclusions were drawn. The authors provided a clear explanation of the studied issue and justified the suggested treatment as well as the research methodology. The article explicitly describes how procedures of sampling, randomisation and blinding were carried out. The results were statistically analysed and sufficiently interpreted. The primary inference is that the chosen study is credible and relevant: the research methodology and design are justified, the investigation results are well interpreted, and the discussion is exhaustive.
The current study appears highly valuable to practice since researchers suggest an efficient rehabilitation program for patients suffering from chronic LBP. Applied methods were rarely utilised simultaneously, yet conducted research showed significant improvements and beneficial outcomes in patients’ health, condition, well-being and life quality. Moreover, the authors compared this treatment program in different settings and justified the utilisation of e-health reporting substantial affirmation of online support’s positive impact.
Nevertheless, the current research has several weaknesses, of which the crucial one is regarding the duration of the study. The follow-up was performed in a relatively short term, and the authors could not ensure the maintenance of the achieved results in more extended time periods. Apart from that, the suggested rehabilitation program is a treatment intervention that should be supervised appropriately. Despite the fruitful results and the cost-effectiveness of this program, an integrated approach is suggested to examine: a combination of traditional healthcare and e-health technologies. Thus, carrying out longitudinal high-quality randomised controlled trials that reproduce and ameliorate the current rehabilitation program are the recommendations for further research.
References
Critical Appraisal Skills Programme. (2020). CASP Randomised Controlled Trial Checklist [Online]. Web.
Facci, L. M., Nowotny, J. P., Tormem, F., & Trevisani, V. F. M. (2011). Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Medical Journal, 129(4), 206-216.
Lara-Palomo, I. C., Antequera-Soler, E., Matarán-Peñarrocha, G. A., Fernández-Sánchez, M., García-López, H., Castro-Sánchez, A. M., & Aguilar-Ferrándiz, M. E. (2022). Comparison of the effectiveness of an e-health program versus a home rehabilitation program in patients with chronic low back pain: A double blind randomized controlled trial. Digital Health, 8, 1-11.
Mbada, C. E., Olaoye, M. I., Dada, O. O., Ayanniyi, O., Johnson, O. E., Odole, A. C., Ishaya, G. P, Omole, O. J, & Makinde, M. O. (2019). Comparative efficacy of clinic-based and telerehabilitation application of McKenzie therapy in chronic low-back pain. International Journal of Telerehabilitation, 11(1), 41-58.
Willan, A. R. (2001). Analysis, sample size, and power for estimating incremental net health benefit from clinical trial data. Controlled Clinical Trials, 22(3), 228-237.
