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Background
Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.
Methods
The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program.
The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).
Discussion
An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.
Trial registration
DRKS, DRKS00020373. Registered on 15 April 2020
Introduction: Chronic low back pain (LBP) is a major cause of disability; early diagnosis and stratification of care remain challenges.
Objectives: This article describes the development of a screening tool for the 1-year prognosis of patients with high chronic LBP risk (risk stratification index) and for treatment allocation according to treatment-modifiable yellow flag indicators (risk prevention indices, RPI-S).
Methods: Screening tools were derived from a multicentre longitudinal study (n = 1071, age >18, intermittent LBP). The greatest prognostic predictors of 4 flag domains ("pain," "distress," "social-environment," "medical care-environment") were determined using least absolute shrinkage and selection operator regression analysis. Internal validity and prognosis error were evaluated after 1-year follow-up. Receiver operating characteristic curves for discrimination (area under the curve) and cutoff values were determined.
Results: The risk stratification index identified persons with increased risk of chronic LBP and accurately estimated expected pain intensity and disability on the Pain Grade Questionnaire (0-100 points) up to 1 year later with an average prognosis error of 15 points. In addition, 3-risk classes were discerned with an accuracy of area under the curve = 0.74 (95% confidence interval 0.63-0.85). The RPI-S also distinguished persons with potentially modifiable prognostic indicators from 4 flag domains and stratified allocation to biopsychosocial treatments accordingly.
Conclusion: The screening tools, developed in compliance with the PROGRESS and TRIPOD statements, revealed good validation and prognostic strength. These tools improve on existing screening tools because of their utility for secondary preventions, incorporation of exercise effect modifiers, exact pain estimations, and personalized allocation to multimodal treatments.