Abstract
Question and Outcome Measures: In this study, an intervention group (multimodal therapy for chronic back pain) and a control group (standard outpatient treatment) were compared with regard to the primary endpoint of pain (NRS) at rest and the secondary endpoints pain (NRS) during movement, general health status (Short Form 12 (SF-12)), health-related quality of life (EQ-5D-5L), pain disability index (PDI), Hospital Anxiety and Depression Scale-Germany (HADS-D), and Hannover Functional Ability Questionnaire for Measuring Back Pain-Related Disability (FFbH-R). Design and Participants: The total patient cohort of this prospective observational multicenter study consisted of 477 patients who were initially enrolled in the study from January 2019 to September 2020. Intervention: The intervention group received physiotherapy, pain therapy (pain-therapeutic, body-related, and patient-specific treatment), and control examinations from the responsible physician in a 6-month structured interdisciplinary program. The evaluation points used in the analysis are the baseline survey, 6 months and 12 months after the start of the study. Results: A total of 477 patients (243 in the intervention group and 234 in the control group) were included in the analysis; 42 patients in the intervention group deviated from the eligibility criteria due to insufficient adherence to study participation. Nonetheless, they were included in the analysis in line with the ITT principle. The primary endpoint, pain at rest (NRS), showed greater reductions in the intervention group compared to the control group, with mean differences of -0.492 (95% CI: [-0.866, -0.118], p = 0.010) at 6 months (EVA 3) and -0.463 (95% CI: [-0.837, -0.089], p = 0.015) at 12 months (EVA 5), respectively. Regarding the secondary endpoints, pain during movement exhibited a significantly greater reduction in the intervention group compared to the control group (p < 0.001). Quality of life, measured via the EQ-5D-5L index, improved significantly more in the intervention group than in the control group, as did functional capacity (FFbH-R) and physical health (SF-12 KSK) (p < 0.001). In contrast, mental health (SF-12 PSK) declined significantly during the intervention (p < 0.001). Disability (PDI) exhibited a significantly greater reduction in the intervention group compared to the control group (p < 0.001), whereas anxiety and depression levels (HADS-D) showed only slight changes in both groups, with anxiety being significant at p = 0.0164 and depression not significant at p = 0.1093. These results underscore the intervention's effectiveness across multiple health dimensions, particularly pain reduction and quality of life. Conclusion: Multimodal pain therapy over a 6-month period is an effective intervention to improve the perception of pain at rest and during movement while enhancing the subjective quality of life. These benefits persist beyond the therapy period, underscoring the intervention's lasting impact. Trial Registration: German Clinical Trials Register: DRKS00015800.