Conclusion

(Kopie 4)

In summary, we would argue that the significant limitations make the presented conclusions highly debatable. The inadequate reporting and the lack of pre-registered protocol are serious problems and the main aim of the study was not addressed. Furthermore, the selected participants and treatment strategies, seemed to strongly favor the active group over the control. The presentation of the results appears to be incomplete, error-prone and does not allow appropriate analysis.

Therefore, we are very worried about the planned extension of the study. We feel it would be ethically problematic to include further participants in a study that does not add any clinical or scientific benefit and, in the worst case, negatively impacts on patients´ recovery. We would also like to emphasize the fact that in the Canton of Aargau in Switzerland, the Ethics Committee Northwestern and Central Switzerland is responsible for clinical trials and not the IST-University Düsseldorf.

Sports Nutrition
Answer of the Authors - online only

Answer of the Authors „The Sustainable Effectiveness to Avoid Chronification in Non-Specific, Non-Chronic Back Pain“

Antwort „Die nachhaltige Wirksamkeit zur Vermeidung von Chronifizierung bei unspezifischen, nicht chronischen Rückenschmerzen“

Answer of the Authors

Thank you very much for your extensive interest in our work and your detailed criticism. In the following you will find explanations to your comments.

1) 2) The standards for performing a correct pilot oriented RCT were adhered to and reviewed in advance by the Ethics Committee (EC) responsible for this study. No violations of the rules were noted. Due to the guidelines of the journal, only 5 illustrations including tables were published.

3) The aims of this prospective RCT were to determine which therapeutic strategy is most effective and sustainable to reduce NLBP and avoid chronification of non-chronic NLBP patients in Switzerland (7). The explanations also contain the definition of the corresponding chronic condition (2, 3) (Introduction, section 1 and table 1).

4) The difference in 1 of the 2 COU in the MCG was clearly explained. The patients were not subjectively or negatively influenced at COU (against one type of treatment). This additional information was necessary to initiate the corresponding MT and is known to that effect (Material and Methods, section 11) (3,4, 5).

5) We used a treatment program following some results of studies (1, 2, 3, 4, 5, 6). Nevertheless, both groups improved. The ECG seems to achieve more sustainable results, which is in line with the results of other studies (Discussion and Critical Comparisons, section 1).

6) The therapeutic methods described in the study (MCG) do not refer to the whole Maitland concept, but only to a part of it (Materials and Methods, section 13).

7) The authors of this study selected the criteria shown to define the groups, which also applied to both groups and were therefore comparable. Other research showed that inactivity promotes the development of LBP and chronification (1).

8) With the Friedmann test, comparisons of measurements within the groups (dependent samples) are calculated, with the Mann-Whitney-U-Test (independent samples). This is clearly presented in the results section (Statistics, Results, section 1).

9) You're right. Table 2 shows the test statistic. In our opinion, these data are important. All relevant data can also be found written in the text. The decimal values have no influence on the results.

10) You're right. The gender definition in the tab. differs. This does not represent a significant difference in the results. However, we will pay attention to this in the future. Thank you!

In summary, our study showed limitations, as have many others. We learn from every feedback and it will influence our further work. We hope that these explanations are sufficient and we are very interested in new researches from you. Many thanks for your constructive criticism.

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  5. FURLAN AD, YAZDI F, TSERTSVADZE A, GROSS A, VAN TULDER M, SANTAGUIDA L, GAGNIER J, AMMENDOLIA C, DRYDEN T, DOUCETTE S, SKIDMORE B, DANIEL R, OSTERMANN T, TSOUROS S. A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain. Evid Based Complement Alternat Med. 2012; 2012: 953139.
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  7. KRANKENPFLEGE-LEISTUNGSVERORDNUNG DES SCHWEIZERISCHEN EIDGENÖSSISCHEN DEPARTEMENT DES INNERN (EDI). Art. 5 Abs. 2 KLV.
Andreas Alt, M.Sc.Manager, Department of PhysiotherapyFit 4 Life AGHardstrasse 105301 Siggenthal, Switzerlandandreas.alt@fit4life.ch