Beschreibung und empirische Fundierung des verhaltenstherapeutischen Moduls der MiSpEx-Intervention

et al. 2016

Trials

BackgroundArising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain.Methods and study designA multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed. The control group stays inactive during this period. Outcomes are pain, and pain-associated function as well as motor function in adults with nonspecific low back pain. Each participant is scheduled to five measurement dates: baseline (M1), following centre-based training (M2), following home-based training (M3) and at two follow-up time points 6 months (M4) and 12 months (M5) after M1. All investigations and the assessment of the primary and secondary outcomes are performed in a standardized order: questionnaires – clinical examination – biomechanics (motor function). Subsequent statistical procedures are executed after the examination of underlying assumptions for parametric or rather non-parametric testing.DiscussionThe results and practical relevance of the study will be of clinical and practical relevance not only for researchers and policy makers but also for the general population suffering from nonspecific low back pain.Trial registrationIdentification number DRKS00010129. German Clinical Trial registered on 3 March 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1645-1) contains supplementary material, which is available to authorized users.

Section: Methodsmentioning

confidence: 99%

Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial

Niederer

Vogt

et al. 2016

Trials

“…The exercise intervention included four different sensorimotor exercises, of which two directly trained the core stabilizing and core surrounding muscles, while the other two indirectly trained upper and/or lower extremities (detailed description see [27,29,30]). At the centre-based phase, the subjects were guided by sports-and physiotherapists, while the home training was audio-guided by a DVD.…”

Section: Interventionmentioning

confidence: 99%

“…The randomized controlled multicenter trial contained a broad measurement set up (such as questionnaires for the assessment of stress, depression, anxiety, fear-avoidance, pain vigilance, social support/attachment and lifestyle) which is not described in detail here, because the manuscript is focusing on the quality of the Risk Prevention Index (RPI-S, e.g., [29,32]).…”

Section: Instrumentsmentioning

confidence: 99%

Personalized Treatment Suggestions: The Validity and Applicability of the Risk-Prevention-Index Social in Low Back Pain Exercise Treatments

Puschmann

Drießlein

et al. 2020

JCM

Background: The back pain screening tool Risk-Prevention-Index Social (RPI-S) identifies the individual psychosocial risk for low back pain chronification and supports the allocation of patients at risk in additional multidisciplinary treatments. The study objectives were to evaluate (1) the prognostic validity of the RPI-S for a 6-month time frame and (2) the clinical benefit of the RPI-S. Methods: In a multicenter single-blind 3-armed randomized controlled trial, n = 660 persons (age 18–65 years) were randomly assigned to a twelve-week uni- or multidisciplinary exercise intervention or control group. Psychosocial risk was assessed by the RPI-S domain social environment (RPI-SSE) and the outcome pain by the Chronic Pain Grade Questionnaire (baseline M1, 12-weeks M4, 24-weeks M5). Prognostic validity was quantified by the root mean squared error (RMSE) within the control group. The clinical benefit of RPI-SSE was calculated by repeated measures ANOVA in intervention groups. Results: A subsample of n = 274 participants (mean = 38.0 years, SD 13.1) was analyzed, of which 30% were classified at risk in their psychosocial profile. The half-year prognostic validity was good (RMSE for disability of 9.04 at M4 and of 9.73 at M5; RMSE for pain intensity of 12.45 at M4 and of 14.49 at M5). People at risk showed significantly stronger reduction in pain disability and intensity at M4/M5, if participating in a multidisciplinary exercise treatment. Subjects at no risk showed a smaller reduction in pain disability in both interventions and no group differences for pain intensity. Regarding disability due to pain, around 41% of the sample would gain an unfitted treatment without the back pain screening. Conclusion: The RPI-SSE prognostic validity demonstrated good applicability and a clinical benefit confirmed by a clear advantage of an individualized treatment possibility.

“…Measurement during this twelve-week intervention program took place at the beginning of the program (M1), after 3 (M2), 9 (M3), 12 (M4), and 24 weeks (M5). In each measurement, questionnaires (for an assessment of psychosocial risk factors and mental health), physical examination, and biomechanical measurements (for an assessment of physical function) were applied (for an overview of the overall study design, see [19]). The study was registered as a clinical trial on 05/16/2013 in the German Clinical Trial Register with the identification number: DRKS00004977.…”

Section: Design and Proceduresmentioning

confidence: 99%

“…The above described SMT training was supplemented with (1) a cognitive distraction task during the SMT (see also [34,35]); (2) a body scan unit directly after the SMT; and 3psychoeducation. All three modules were provided via DVD and were delivered as an integrated part of the SMT training (cognitive distraction and body scan unit) or as a separate component (psychoeducation) (see also [19]).…”

Section: Multidisciplinary Interventionmentioning

confidence: 99%

The Feasibility and Effectiveness of a New Practical Multidisciplinary Treatment for Low-Back Pain: A Randomized Controlled Trial

Drießlein

Beck

et al. 2019

JCM

Low-back pain is a major health problem exacerbated by the fact that most treatments are not suitable for self-management in everyday life. Particularly, interdisciplinary programs consist of intensive therapy lasting several weeks. Additionally, therapy components are rarely coordinated regarding reinforcing effects, which would improve complaints in persons with higher pain. This study assesses the effectiveness of a self-management program, firstly for persons suffering from higher pain and secondly compared to regular routines. Study objectives were treated in a single-blind multicenter controlled trial. A total of n = 439 volunteers (age 18–65 years) were randomly assigned to a twelve-week multidisciplinary sensorimotor training (3-weeks-center- and 9-weeks-homebased) or control group. The primary outcome pain (Chronic-Pain-Grade) as well as mental health were assessed by questionnaires at baseline and follow-up (3/6/12/24 weeks, M2-M5). For statistical analysis, multiple linear regression models were used. N = 291 (age 39.7 ± 12.7 years, female = 61.1%, 77% CPG = 1) completed training (M1/M4/M5), showing a significantly stronger reduction of mental health complaints (anxiety, vital exhaustion) in people with higher than those with lower pain in multidisciplinary treatment. Compared to regular routines, the self-management–multidisciplinary treatment led to a clinically relevant reduction of pain–disability and significant mental health improvements. Low-cost exercise programs may provide enormous relief for therapeutic processes, rehabilitation aftercare, and thus, cost savings for the health system.