How to prepare an optimal design of a clinical study focusing on chronic low back pain: guidelines based on a review of scientific papers published in 2014-2019
Abstract
Introduction: Chronic low back pain (LBP) is one of the most common diagnoses in the current adult population and has been therefore subject to extensive scientific research. However, the design of individual scientific studies differs fundamentally in many respects, which makes it impossible to compare their results.
Based on a detailed research of recent papers published in international journals with impact factor, this article offers guidelines how to appropriately design studies evaluating the effect of therapeutic procedures in LBP. Methods: Clinical studies published from March 2014 to June 2019 in journals ranked in the first half of the impact factor ranking in the Rehabilitation category according to the Journal Citation Reports were selected in the PubMed database.
The main search MeSH (Medical Subjects Headings) parameter was "low back pain". The following data were analysed: number of participants in the experimental and control group, inclusive and exclusive criteria, definition of the control group, intervention design, measured parameters and measurement tools.
Results: A total of 66 original works were included in the final analysis. The median number of participants included in a study was 72.5.
The most frequently evaluated interventions nadhodnocowere exercise programs (29/66). The most common duration of intervention was 4-8 weeks (28/66), the most common frequency of intervention was twice a week (15/40).
The control group received less care than the intervention group in almost half of the studies (25/55). A questionnaire survey (65/66) was most often used to evaluate the effect of the intervention.
Instrumental evaluating methods (18/66) and clinical tests (11/66) were applied less frequently than patient reported outcome measures (65/66). The parameters that were evaluated by questionnaire methods were most often pain (58/66) and disability (58/66).
Pain was most often assessed via numeric pain rating scale (28/66) or visual analogue scale (22/66). Disability was most often evaluated by the Roland-Morris Disability Questionnaire (28/65) and the Oswestry Disability Index (18/65).
Conclusion: Based on the literature search, this paper recommends procedures to optimally design studies objectifying different types of treatment methods in LBP patients.