A Randomized Trial: The Blankenstein Healthcare Plan Improves Sustainability of Lifestyle Change After Inpatient Naturopathic Therapy for Chronic Back Pain

Ordnungstherapie is the core of 5 areas of classical European naturopathy and focuses on salutogenesis and ways to deal and live with illness. The new tool Blankenstein healthcare plan (HCP) helps to integrate health-promoting activities into the daily routine. Using the Blankenstein questionnaire (BQ) this single-center randomized controlled trial examines whether HCP improves desired lifestyle changes in patients with chronic back pain. The main outcome measure is the difference between the weighted mean values of the BQ after 3 months and at the beginning. From 2011 to 2015, 600 female patients from the Department of Naturopathy were randomized whether or not to use the HCP in addition to in-patient naturopathic complex therapy. The BQ consists of visual analogue scales for the categories of “Ordnungstherapie”: conscious nutrition, exercise and sports, stress and mental stress, naysaying ability, joy of being despite illness, and care of the soul. The importance of these areas is weighted and scored individually. The weighted mean values of the BQ improved significantly after 4 weeks and 3 months in both treatment groups, but significantly more in the group with a HCP (p<0.0001). No undesired effects were observed. WAVVAS: Weighted Mean Value of the VAS; CARE: Consultation and Relational Empathy; ITT: Intention to Treat; FFbH-R: Hannover Functional Ability Questionnaire Score; PP: Per Protocol; SD: Standard Deviation; LOCF: Last Observation Carried Forward; 95%-CI: 95%-Confidence-Interval; SLC: School Leaving Certificate; T0: At Enclosure; T1: After Inclusion in the Study; T2: At Discharge; T3: At 4 Weeks; T4: At 3 Months Inpatient Naturopathic Therapy for

The term "Ordnungstherapie" was introduced by the Swiss physician Bircher-Benner   [4,5]. The focus is not on pathogenesis but is instead oriented around salutogenesis, which is an approach to human health that examines the factors contributing to the promotion and maintenance of physical and mental well-being rather than disease with particular emphasis on the coping mechanisms of the individual. Mind-body medicine works with objectively describable behavioral routines that influence spiritual and physical health. These include healthy eating and exercise routines, an appropriate lifestyle rhythm, the capability to reduce and to handle stress, successful processing lifestyle and the coping strategies applicable for these are learned.
Mind-body medicine is characterized by the concept that the specialist knowledge of the experts in the relevant areas and the experience of the patient are both necessary to achieve the goals set.
In many cases, patients lack the capacity to establish a routine, that is, to create a health-promoting lifestyle that they use in their day-today life. The long-term success of a treatment is dependent on this skill [8]. Studies on the effects of lifestyle modifications triggered by mind-body medicine generally document their effectiveness and sustainability [9][10][11]. Success in mind-body medicine has also been shown in cardiology, oncology and pain treatment [12]. In the USA around 18.9% of patients applied mind-body medicine, which is kin to "Ordnungstherapie" [13]. Spirituality is an important resource in handling illness [14].
"Study findings (from exercise intervention studies) call for greater research and programmes efforts to maintain health, function, and physical activity behaviour after supports provided by research studies are removed" [21]. These observations and results from investigations on sustainability [22][23][24] led us to the development of a standardized form so that the process of mindbody medicine is rendered transparent and can be implemented by different therapists. To achieve this, two new therapy tools were created: the "Blankenstein questionnaire" (BQ) and the "Blankenstein healthcare plan" (HCP). Chronic back pain was selected as inclusion criterion as around 17% of the German population suffer from chronic pain, most of them are suffering from back pain -85% at least once during their lifetime [25]. As the majority of patients treated in the Clinic for Naturopathy are women, the study is limited to female participants [26,27].

Investigation Design
1) This is a single-center randomized controlled trial with equal group size at the Clinic for Naturopathy in Blankenstein (Hattingen).
2) The patients did not receive any financial compensation.
3) The study was executed from November 2011 to August 2015. Table 1.  The type and extent of the implementation of the following behaviors was queried: The patients worked with their therapists to establish where change was desired in each of the six areas for their individual case. A weighting of the individual significance of these areas was also carried out by allocating a total of 10 points to them. Based on this, the weighted mean value of the VAS (WAVVAS) was calculated (example: chosen areas "Ability to say no"/score 4/allocated points 7 and "Looking after the soul"/score 6/allocated points 3;

4) Inclusion and exclusion criteria are shown in
WAVVAS=(4*7+6*3)/10=4,6). The minimum possible value is "0", the maximum "10", decimal places are allowed.   The Ordnungstherapist supports the patient in formulating the HCP. Once the HCP has been created, it is signed by both the patient and therapist, which increases the probability that it will be implemented [23]. The creation of the HCP places great value on the individuality and multidisciplinary nature of the treating team.
a) The HCP is created by addressing the areas that the Hannover Functional Ability Questionnaire: The FFbH-R is a standardized questionnaire to measure the physical functional impairments that occur in conjunction with the back pain (scale from 0% to 100%, <70%: moderate restriction of the functional capacity). Unlike the BQ, the FFbH-R does not focus on the patient's estimations but instead seeks to reflect their physical condition as objectively as possible [32,33].

Beck Depression Inventory:
The BDI has been used nationally [34] and internationally [35] for over 30 years. It is a psychological test that detects the severity of depressive symptoms in the clinical setting (21 questions with four possible answers each / 0-3 points; sum ≥29: severe depression). The reliability and validity are high

Randomization
The patients were randomly allocated to the two treatment groups by an Ordnungstherapist using a program which generates pseudo-randomized numbers whose probability is adapted to

Registration
The study was carried out in accordance with the statements

Recruitment and Study Workflow
The Flowchart of participant recruitment and study procedures is shown in Figure 3.

Anthropometric and Epidemiological Data
Demographic, physical and mental initial parameters for the patients are shown in Table 2. Additional anthropometric and epidemiological data are given in Tables 3-5. The level of confidence that change can be achieved is higher in the group with a HCP, both in terms of their own estimation and therapists' estimation.

WAVVAS After 3 Months (Main Outcome)
In total, 26 patients from the group with the HCP and 34 patients from the control group could not be evaluated in the PP analysis due to missing data (the reasons are given in Figure 3). One patient with HCP could not be evaluated in the PP analysis due to mixed treatment. The result of the ITT analysis and of the PP analysis of the differences in the WAVVAS (at 3 months versus baseline) with comparison of the two treatment groups is shown in Table 6.

WAVVAS After 4 Weeks (Secondary Outcome)
The result of the ITT analysis and PP analysis of the differences in the WAVVAS (at 4 weeks versus baseline) with comparison of the two treatment groups is shown in Table 7.

Other Secondary Outcomes
The further treatment and course results are presented for the PP analysis. The calculations were also carried out for the ITT groups, without producing significantly differing results. Change in back pain, mental well-being and FFbH-R is shown in Table   8. Change in back pain and change in mental well-being was not different between control und HCP-group at any point of time (p-values between 0.09 and 0.93; t-test) (  Last row of each item: Mean: 5-part Likert-scale: 1 = " Significantly improved"; 5 = "Significantly worse" Note on the averages: 3 in the semiquantitative scale corresponds to "no change", Values <3 correspond to an improvement over the previous query.

Discussion
Randomization led to comparable treatment groups without relevant differences in the starting parameters for both groups.
Limitations of the study and its statements result from the restriction to the female gender, so that a possible transferability to men remains unclear. It also remains unclear whether the HPC can also be used effectively in the outpatient area. The level of confidence that change can be achieved is higher in the group with a HCP, both in terms of the patients and the therapists' estimation.
It could be that bias has an effect here as the patients and the care providers knew about the group assignment at this point and potentially hoped that they would benefit from the HCP being tested. The better result of the Ordnungstherapist in the CARE form for the group with the HCP may be due to the increased intensity of care that the group with the HCP experienced. As we have seen from both previous scientific monitoring sessions, naturopathic complex therapy improves the functional impairments caused by back pain in both treatment groups, and therefore for the population as a whole. This was measured with the FFbH-R over the course of the 3 month observation period and is significant.
No difference between the treatment groups could be evidenced here. Both treatment groups and therefore the entire study population had significant treatment success from the naturopathic complex therapy, as evidenced by the parameters measured by the BQ at all times. The effect size is strong. Whether the new use of the measuring instrument BQ itself is at least partly responsible for this cannot be decided with the current study design. The HCP leads to a significant and quantitatively meaningful increase in treatment success in both the PP analysis and the ITT analysis. Because the follow-up period was limited to 3 months, the long-term generalization of the results remains a task for future studies. It also remains to be seen whether the improvement in back pain with HCP lasts longer in the long term, so that the results of the Hannoveraner Bogen and measurements of the quality of life not directly and validated examined in this study also lead to demonstrable significant differences after a few years.

Conclusion
The HCP, used in conjunction with the BQ, is a valuable instrument in securing long-term success of mind-body medicine