In their research, Miller et al. (2012) dwelled on the application of ultrasound in therapeutic treatments and discussed the best ways to minimize side-effect risks and help patients as much as possible. They mentioned that ultrasound had several definite benefits supported by evidence and could be used to increase patient safety when the clinician dealt with chronic pains (Miller et al., 2012). Throughout the research process, the investigators found that the amount of safety information is either insufficient or confusing. Research on the subject of ultrasound therapy revealed that even commercial conflicts might arise throughout the implementation of this kind of treatment. Miller et al. (2012) also highlighted the significance of communicating the safety principles to the patients that were subject to being treated using ultrasound. Their qualitative meta-analysis of the effects of ultrasound on the quality of therapeutic approaches to chronic pains helped find numerous ultrasound methods that can be utilized in different situations. Overall, Miller et al. (2012) proved that the clinical use of ultrasound bears a positive connotation to patient outcomes, and the safety of this method is one of the biggest advantages.
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Another research project intended to support the use of ultrasound therapy was conducted by Ulus et al. (2012). In that study, they addressed the short-term impact of ultrasound therapy in the cases where it was necessary to ease the pain or restore physical functions of the patients. Ulus et al.’s (2012) study involved several patients (42) with knee osteoarthritis. A researcher that was not involved in the evaluation of the outcomes randomized the sample, and two groups were formed – continuous ultrasound therapy and sham ultrasound therapy.
All of the participants of the study (patients) were subject to receiving 20 minutes of hot packs and at least 15 minutes of specific knee-focused isometric exercises in addition to ten minutes of interferential current (Ulus et al., 2012). The treatment was received throughout three weeks straight (five times per week). The researchers evaluated the data based on the baseline information and the end date. To measure the outcomes, Ulus et al. (2012) used a visual analog scale, a specific osteoarthritis index, Lequesne index, and depression scale. Nonetheless, the study outcomes showed that the application of ultrasound in association with conventional physiotherapy does not have any significant effects on patients with knee osteoarthritis. Instead, it was recommended to apply ultrasound therapy exclusively.
The Gap in Scientific Knowledge
The gap in scientific knowledge is accurately addressed by the authors of the reviewed research study. Their research points at several factors that had not been discussed in the previous literature on the subject of continuous ultrasound. This study is different because Ebadi et al. (2012) dwell on the evidence regarding the effectiveness of physiotherapy practices aimed at treating chronic LBP. Owing to this research project, it turned out that the presence of an effect mitigated the lack of evidence. Therefore, it is safe to say that such findings impact the field of the use of ultrasound for the treatment of chronic pains and prove its efficiency. Ebadi et al. (2012) stated that their research results might bear several practical implications for the healthcare facilities that are keen on finding new treatment methods for patients with chronic back pains.
Within the framework of the research project conducted by Ebadi et al. (2012), the research problem consisted in the fact that the effects of continuous ultrasound were underresearched. The investigators especially became interested in addressing the issue of continuous/ placebo ultrasound therapy and its effect on the patients with NSCLBP. Additionally, Ebadi et al. (2012) saw the problem in investigating the secondary outcomes such as the endurance of lower back muscles and lumbar variety of locomotion.
There was no hypothesis in the study conducted by Ebadi et al. (2012). Still, the research question revolved around the idea that ultrasound might be a useful instrument when dealing with patients suffering from the NSCLBP. The researchers were able to answer this question and provide relevant evidence to support their point of view.
This is mixed research that features both qualitative and quantitative characteristics. The researchers outlined the methodology as follows: 50 patients with NSCLBP took part in the blind placebo-controlled study. To follow the study design, the patients were randomized into two groups – placebo ultrasound (and extra exercises) and continuous ultrasound (with extra exercises as well) (Ebadi et al., 2012). The process of treatment took four full weeks. There were ten treatment sessions with a frequency of three times a week. To randomize correctly, the researchers used opaque taped up envelopes. The latter was arranged by a statistician that created a randomization schedule using a computer. All the envelopes were distributed equally between the subjects of both groups. This study design allowed the researchers to minimize the level of bias and answer the research question because they backed the theoretical findings with statistical data.
To measure the outcomes of the study, Ebadi et al. (2012) used the functional rating index (to address the primary outcome of functional disability) and a visual analog scale (to assess the global pain. There was also feedback data collected using a questionnaire. Throughout their observations, the investigators recorded all the information using electronic data collection forms.
Population and Sampling Plan
There were several inclusion criteria that Ebadi et al. (2012) enumerated in their research article. Those included the presence of NSCLBP and age limit (18-60). On the other hand, there were numerous exclusion criteria: the presence of systemic diseases, previous lower back surgery, specific psychological problems, pregnancy, and fractures (Ebadi et al., 2012). The sample (2 groups, 23 participants each) consisted of the patients coming from three Tehran hospitals. All the study participants were required to sign a consent form and acquire the information regarding the experiment. The information that was presented by Ebadi et al. (2012) may be helpful, but it is not enough to recreate their study. There was no clear rationale for the researchers’ sampling decisions, but they aligned their project with the expected sample size. There were identified no supporting sources that would justify the sample size decision. Ebadi et al. (2012) were able to conduct the study “as is” and did not have to review their sampling plans.
To obtain all the necessary electromyographic data, Ebadi et al. (2012) used an 8-channel EMG recorder. After the data acquisition, it was analyzed using the built-in software titled DATA LOG. According to the information presented by Ebadi et al. (2012), the signal was gathered at 1000 Hz and 1000 decibels. All the outcome measures were documented at the starting point, after the end of the study, and one month after the end of the study. According to the information in the article, the author of this submission may claim that there is not enough data available to replicate the study despite a detailed description of the instruments used. One of the missing things is the direct outline of collecting the data, which may be rather important because incorrect study design may cause adverse outcomes in the study participants.
The majority of the findings outlined by Ebadi et al. (2012) revolved around the idea that the patients receiving continuous ultrasound treatment had a higher endurance time rate than their placebo counterparts. Within this research framework, the investigators defined endurance as the ability to sustain mobile activity (which is directly associated with fatigue). The researchers concluded that one of the main predictors of muscle fatigue is the presence of metabolite wastes in the lower back region. Continuous ultrasound was found to increase blood circulation and trigger muscle contraction, which ultimately led to improved low back muscle strength. It may be concluded that Ebadi et al. (2012) successfully answered their original research questions within the framework of the reviewed research study.
The most important limitation of the study consisted in the fact that the treating physiotherapist knew everything about the group allocation (Ebadi et al., 2012). This means that the collected data may be biased, and consequently, this may be considered the biggest weakness of this particular study. Another limitation was the number of patients that decided to drop out of the study (approximately 22%) (Ebadi et al., 2012). One of the areas of the study that cannot be improved is the self-reported compliance rate. On the other hand, throughout their future research on the topic, Ebadi et al. (2012) may slightly revise the study’s design to be able to observe individual interventions discretely. Bearing in mind the limitations mentioned above, there is a need to redesign the study to obtain valid results.
Further research in the area will have to concentrate on the differential effects of various interventions (including those described in Ebadi et al.’s (2012) study on NSCLBP patients. Also, the author of this submission believes that future investigation on the topic of NSCLBP should include the measurement of electromyography parameters not included in this research article (for instance, normalized median and mean frequency). This may help the researchers to inspect the impact of these parameters on the patients with NSCLBP. In addition to this, the future research in the area should critically focus on the methodological shortcomings of Ebadi et al.’s (2012) study and verify the outcomes in patients with chronic low back pain related to the dose-response.
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All of the permissions were granted by the Tehran University of Medical Sciences (including the Ethical Committee and the Research Council). The Netherlands Trial Registry validated the experiment. At the time of the experiment, the site did not have a separate IRB. To obtain all the necessary permissions, Ebadi et al. (2012) asked for informed consent and went through the previous literature.
The researchers contacted the future participants of the study at the territory of the healthcare facility. After the study was over, all the participants were contacted again to share the outcomes and provide the necessary recommendations. It may be concluded that Ebadi et al. (2012) approached the participants in a correct manner and made them feel safe.
From the study’s design, we may learn that the study is in line with all the necessary ethical considerations. The authors did not discriminate against anyone and kept the personal data safe. After the research study was over, Ebadi et al. (2012) carefully analyzed the data and made everything possible not to disclose the study results before validating the obtained information. Overall, the researchers did a great job of protecting the participants from any internal or external adverse influence.
The author of this submission did not identify any serious risks that could impact any study participants or examiners. Therefore, the study is within the limits of minimal risk and can be considered reliable. The population that was reviewed in the article could be considered vulnerable. Nonetheless, the level of risk would not differ significantly when the participants were a part of the vulnerable population. The authors of the reviewed study protected their participants by limiting their medication intake and getting used to the specific exercises.
Ebadi, S., Ansari, N. N., Naghdi, S., Jalaei, S., Sadat, M., Bagheri, H.,… Fallah, E. (2012). The effect of continuous ultrasound on chronic non-specific low back pain: A single blind placebo-controlled randomized trial. BMC Musculoskeletal Disorders, 13(1), 192.
Miller, D. L., Smith, N. B., Bailey, M. R., Czarnota, G. J., Hynynen, K., & Makin, I. R. S. (2012). Overview of therapeutic ultrasound applications and safety considerations. Journal of Ultrasound in Medicine, 31(4), 623-634.
Ulus, Y., Tander, B., Akyol, Y., Durmus, D., Buyukakıncak, O., Gul, U.,… Kuru, O. (2012). Therapeutic ultrasound versus sham ultrasound for the management of patients with knee osteoarthritis: A randomized double‐blind controlled clinical study. International Journal of Rheumatic Diseases, 15(2), 197-206.