Abstract
BackgroundTo investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China).Methods140 patients with cnsLBP were randomly allocated to rESWT (n = 47), rESWT + C + E (n = 45) or C + E alone (n = 48) for four weeks between November 2017 and March 2019. Outcome was evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline.ResultsAll scores showed a statistically significant improvement over time. The PSEQ and NRS scores showed a significant Time × Treatment effect. Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4. No severe adverse events were observed.ConclusionsrESWT may not be inferior to respectively rESWT + C + E or C + E alone in reducing pain in patients with cnsLBP. Level of Evidence: Level I, prospective, randomized, active-controlled trial.Trial registration: Clinicaltrials.gov Identifier NCT03337607. Registered November 09, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03337607.Level of evidenceLevel I; prospective, randomized, controlled trial.
Highlights
To investigate whether respectively radial extracoporeal shock wave therapy or a combination of rESWT, celecoxib and eperisone are superior in reducing pain in patients with chronic nonspecific low back pain compared to C + E alone
The Pain Self-Efficacy Questionnaire (PSEQ) score showed a statistically significant Time × Treatment effect, with no significant difference between groups at any investigated time (Table 5)
Assessment of outcome after treating cnsLBW with rESWT, rESWT + C + E or C + E alone using the Pain Self‐Efficacy Questionnaire A key finding of this study was that the PSEQ score [31] turned out to be unsuitable for evaluating treatment success in this study
Summary
To investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China). The reported point prevalence of nsLBP is as high as 33% [2, 3], and its one-year prevalence is as high as 73% [2, 4]. In China, nsLBP has become one of the leading causes of disability-adjusted life-years in 2010 [6]. The prevalence of nsLBP was reported as 41% in Chinese adolescents [7]. Management of nsLBP is challenged by the problems that most back pain has no recognizable cause (> 85%), an underlying systemic disease is rare, and most episodes of back pain are unpreventable [2, 5, 8]. Risk factors for the development of disabling chronic nsLBP (cnsLBP) include preexisting psychological distress, disputed compensation issues, other types of chronic pain and job dissatisfaction [8,9,10]
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