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The present description is concerned with the critique of a research article related to the comparison of surgical stabilization of the lumbar spine with intensive rehabilitation for patients with chronic low back pain. This condition was reported to enhance the economic concerns in patients leading to a difficult management task. The appropriate remedial strategies described earlier were based on non-operational rehabilitation methods. However, surgical intervention although been considered has remained controversial and inconclusive. In the article, the appropriateness of the outcomes with respect to the study rationale is partial. The researchers have incorporated a questionnaire focusing on back pain and walking tests. The time period of 24 months seems insufficient. The inclusion of the disability index to determine the daily activities is seemingly better. Its association with surgical intervention has not been clearly described.
This could be because the degree of disability might also help to decide whether or not to choose the surgical intervention for chronic pain. In addition, the ODI was reported to be an appropriate primary outcome measure for fusion and nonsurgical treatment of lumbar degenerative disease where chronic low back pain has a prominent role to play (Carreon et al., 2008). Next, the secondary outcome has made in depth analysis of measures specific to physical and mental health by utilizing a scale. Here, the assessment of low back pain or spinal aberrations could be easily understood as it was reported to be potential enough to ensure psychometric support and large data. This outcome can be considered appropriate for the current study. However, the association of this outcome with the surgical relevance could have been highlighted well. Because the rationale of the article is better connected to emphasize the need for surgical therapy. However, the outcomes undertaken have the potential to meet the appraisal in view of their properties. The inclusion of parameters like ODI is a fine clinical decision as it furnishes insights on the severity of chronic low back pain. This added to the utility of questionnaires and the walking test is an added advantage for the clinical professionals to obtain the pros and cons of the rehabilitation program and surgical intervention.
The daily living aspects of the study participants could also be better understood. This is because assessing the duration of chronic low back pain may be difficult in order to initiate precise therapy. In addition, the patients could also be in psychological distress to reveal the pain owing to the financial burden that could incur. Hence, it seems that the authors have described the selected outcome measures keeping in view of the uncertain conditions likely to be met by the participants. Next, the secondary outcome is standard enough to meet the appraisal. Here, a 36-item questionnaire was considered that gives a vivid picture of physical and mental health status. The degree of severity of spinal disorders would be studied with respect to important baseline characteristics. In addition, the inclusion of the distress and risk assessment method (DRAM), is a benefit to the participants who are at risk of acquiring mental illnesses like depression and anxiety with chronic low back pain. This would bring relief and hope also to the patient relatives. In order to alleviate the fear that complications might arise with pain management, the authors have provided useful information with regard to considering the utility of investigations specific to radiology, implantations, and anesthetic agents.
Further, as the article rationale is more connected with the surgery, the authors have also emphasized its complications in relation to rehabilitation that might pose other threats. This is the study participants recommended for surgery would be more likely to be susceptible for the consequences occurring aftermath, and the assessment of such conditions is safe. This was accomplished by considering surgical intervention recurrence, tools employed for the patients like implants or other items commercially obtained for the purpose. The appraisal of the secondary outcome is more appropriate if the monitoring of work status is described. This is because certain associated conditions might aggravate the problem of low back pain. Hence, the authors were right in recording obvious pseudoarthrosis. This could furnish valuable information to the surgeon regarding the problem encountered and come out with an alternate clinical decision.
There is a need to emphasize data collection. In this study, a total of 349 subjects were included and the data was collected by employing ODI. This could be feeble for reliable analyses. This is because the recruitment seems to be in an unplanned manner as there is only one clinical category. The inclusion of more groups could have made the data accurate. The data on the baseline characteristic is not too well. The utility of drug history is not clear. Patients with low back pain would more tend to choose suitable medications like pain relievers. The drug history might have given information on the likely duration of illness.
In addition, to overcome the psychological distress the patients might also choose a range of Central Nervous System (CNS) medications the evaluation of which helps to assess the mental illness like anxiety and depression. This information is missing in the data collection.
Hence, the questionnaires (SF-36) although have been planed well to provide insights on distress and risk management, they did not incorporate crucial information with regard to the data on drug history. The statistical techniques used in this study could be well appreciated with some pitfalls. The use of covariance (ANCOVA) to determine the outcomes has yielded significant results. With this, the association between the outcomes and clinical profile of the patients at entry in the trial could be strengthened. The variations observed in the clinical characteristics of Spondylolisthesis, Post-laminectomy, and Chronic low back pain in both the study groups have been addressed well statistically. Similarly, the mean indices obtained for planned surgery type and planned fusion level have given a better picture of surgical intervention in both the study groups.
The mean obtained for various baseline characteristics has shed light with regard to the duration of back pain in years with their range. This could help to assess the impact of distress on pain sufferers. In table 4, the outcomes were adjusted for baseline measures which is a good statistical method. This adjustment would help to assess the magnitude of chronic low back pain that is associated with those measures.
The confidence interval (CI) and p values obtained are significant indicating the comparison of outcomes in both study groups is valuable enough to understand the variations in the important parameters like pain, social functioning, mental health, and energy and vitality. Next, for the purpose of missing data, multiple imputations were used. This measure is appropriate in giving information on certain clinical characteristics like planned surgery type, planned fused level and distress. However, the authors could have applied this statistical strategy for other clinical measures in this regard. This might indirectly affect the outcome and probably could enhance the vagueness in understanding the surgery and rehabilitation groups with regard to certain baseline values. The results have indicated that the data was obtained between 1996 and 2002 from 349 patients who were divided into surgery and rehabilitation groups. It is clear from table 1 that the comparison of baseline values among surgery and rehabilitation groups has indicated that there is no large difference in the clinical characteristics of these groups. The effect sizes considered are also not much different. This has indicated that the surgical intervention and rehabilitation programs have a similar effect on the baseline values. This might weaken the chances of surgical intervention that has become a matter of debate to be considered compulsory for the management of chronic low back pain. Table 2 depicts the compliance of study participants with their treatment and follow-up. Here, a total of 139 and 151 patients received allocated intervention in the surgery and rehabilitation programs, respectively. The compliance of the patients is not better with regard to the treatment in both groups. This was due to the very low number of patients responding to the allocated treatment.
This could indicate that the patients are willing to go for alternative treatment strategies.
This was revealed from the data on switching options, physiotherapy, and other described measures presented in Table 2. On the other hand, a total of 97 and 68 patients required further treatment after allocated treatment in both the groups, respectively.
This could indicate that most patients in the study group have willingly responded well to the allocated treatment. These patients are also in need of a follow-up with similar treatment strategies. This has indicated that the treatment pan for chronic lumbar pain needs a treatment repetition to assess the long-term duration of the disease severity. This has also supported the authors description of the requirement of further operations on their lumbar spine in eleven patients. The confidence intervals and significance tests recorded were appropriate. The Owestry scores indicted that surgery is more favored among patients. This was in agreement with the results obtained in table 2 where a large number of patients were recommended for further follow-up in the surgery group. Therefore, the presentation of the data in tabular format is clear. A flow chart depicting the allocation of surgery and rehabilitation to the patients, follow-up from 6 months to 24-month period with primary outcome measures is also well presented.
This would help to understand the study from the initial stage to the completion. The conclusions described that the interventions do not influence the lessening effect observed in disability. Surgery was avoided by most patients indicating that no benefit was derived when compared to rehabilitation. There is a need for a cognitive approach in rehabilitation due to its limited global applications. Rehabilitation also needs extensive resources and support from Health care professionals. The difference between the treatment groups is minimum in the primary outcomes with the need for priority to be given to risk and surgery expenditure. Hence, the interpretation and claims are in favor of evidence presented in various forms through the data obtained, comparisons and statistical evaluation. The findings in general appear to reflect the non-significant utility of the interventions to reduce chronic low back pain. Since the tests and outcome measures did not vary between the treatment groups, their relevance seems to be moderate in studies intended to assess the severity and duration of chronic lumbar pain. The differences in the baseline characteristics have also not been much influential in determining the outcome.
The relevance and usefulness of the findings to the clinical practice are that chronic lumbar pain could be managed b rehabilitation. But this may need extensive follow-up for more than 24 months. The emphasis given for cognitive therapy would yield results when appropriate CNS drug prescription is considered in the practice. From the findings, the drawbacks associated with the surgery could be evaluated or understood, and there would not be much need of recommending the patients to the surgery with the only exception for rehabilitation intervention. The issues highlighted in the paper are that with regard to surgical fusion. Although this strategy has been in use for nearly 90 years, there is a variation within the countries. This was appropriately presented and it influenced the research findings extensively. This was revealed when the data on the utility of surgical intervention was made clear to the audience on whether or not it reduces chronic lumbar pain, and its financial implications. The strengths and limitations of the study are that the researchers have considered a good sample size of 349 which is having the potential to evaluate the study parameters. But this size has interfered with the recruitment by retarding its progress. A good number of patients could have been recruited to expedite the process of data collection. There were professional surgeons in the study which is
sounding for the intervention but uncertainties existed in selecting patients for fusion This would interfere in assessing the appropriate need for spinal fusion. The use of surgical fusion is welcome news for patients, there is no clear description of what kind of surgical technique will be used. This may indicate that there is no uniformity in the application of surgical procedures. The follow-up strategy was sounding but declined to 20 % during the 24 month period. This has blocked the assessment of the validity of the trial. The response rate was moderate and there is no need for multiple imputations which the researchers have used unnecessarily as a tool for sensitivity analysis. The computer analysis of data scoring of outcomes with regard to the pre-randomization is good. But the researchers were unable to be blinded to the patient allocation that might reveal the confidential information. The other pitfalls are the uncertainty of ODI with regard to its clinical relevance and improper treatment compliance.
References
Carreon, LY, Glassman, SD, Howard, J. Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes. Spine J 8.5 (2008):747-55.
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