Trial document




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  DRKS00003326

Trial Description

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Title

3rd Scientific Evaluation of the Department of True Naturopathy at Blankenstein Hospital

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Trial Acronym

3rdSE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The department of True Naturopathy at Blankenstein hospital treats amongst others patients with chronic pain disease. A considerable part of the patients suffer from back pain. The 1st and 2nd scientific monitoring showed that more than 80% of the patients benefit from the treatment, that the effects are comparable to those obtained by orthopedic or rheumatologic departments at a university hospital, and that about half of the patients benefit more than half a year from the treatment. The 3rd scientific monitoring examines the sustained change of life style concerning health related areas by the in-patient naturopathic complex treatment. We examine whether detailed instruction and binding agreement, recorded in a so-called "Gesundheitsfahrplan" (health road map), improves the results. Concretely, recognition, planning and realization of changes in different areas of life are topic of the study.

Annotation: After a pilot phase with 20 patients the standard deviation of the primary end point was calculated. As consequence the number of study participants had to be raised to 600 to reach the desired power of the study (0.8).

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Brief Summary in Scientific Language

The monocentric investigation consists of two parts (pilot phase and general investigation). Female patients of the department of true naturopathy at Blankenstein hospital suffering from chronic back-pain get in-patient naturopathic complex treatment. Patients of the investigational group get an additional "health road map" (Gesundheitsfahrplan) developed togehter with the "Ordnungstherapeuten" (psychologists specialised on mind-body-medicine) for the time after discharge from hospital

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Organizational Data

  •   DRKS00003326
  •   2011/12/01
  •   [---]*
  •   yes
  •   Approved
  •   2011-222-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1126-2032 
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Health Condition or Problem studied

  •   M47 -  Spondylosis
  •   M42 -  Spinal osteochondrosis
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Interventions/Observational Groups

  •   Naturopathic complex in-patient-treatment including "Gesundheitsfahrplan"
  •   Naturopathic complex in-patient-treatment without "Gesundheitsfahrplan"
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Sustainability of life-style change measured by the mean of weighed VAS (Visual analogue scales) at the beginning and after 3 months

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Secondary Outcome

- Sustainability of life-style change measured by the mean of weighed VAS (Visual analogue scales) after 4 weeks
- Questionary for life-style changes collected by telephone interview 4 weeks and 3 months after discharge
- Effectiveness of predictors of health behaviour like gender, education, compliance, ability to confine oneself, ability to care for own spiritual demands, measured by the mean of weighed VAS, the questionary for life-style changes and the data collected by the medical history questionary at the beginning, 4 weeks and 3 months after discharge
- Importance of the mood for the sustainability of life-style change, measured by the BDI (Beck depression inventory) at the beginning of the in-patient treatment
- Possible additional effects of pastoral talks, measured by telephone interview 4 weeks and 3 months after discharge
- Possible effects of compliance on back pain, measured by telephone interview 4 weeks and 3 months after discharge
- Possible effects of the perceived empathy of the treating physician/"Ordnungstherapeut" on the treatment success, measured by the CARE questionary at discharge

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/11/08
  •   600
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- female patients of the deprtment of true naturopathy at Blankenstein hospital
-- Hannover Functional Ability Questionaire Score ≤ 16
- at least one of the following diagnoses (primary diagnosis or first relevant ancillary diagnosis): cervicocephalic syndrome, cervicobrachialic syndrome (ICD10:M47.12/13/22/23/82/83/92/93, M48.02/3, M50, M53.0/1, M54.12/13/2), chronic sciatic pain with or without radicular radiation (ICD10:M42.15/6/7, M42.12/3, M47.15/16/17/25/26/27/85/86/87/95/96/97, M48.05/6/7, M51.1/2, M54.15/16/17/3/4/5)
- written informed consent

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Exclusion Criteria

- male patients
- participation in the study before
- non-compliance
- female patients unable to understand the nature of the study
- chronic pain of different origin requiring analgetic treatment
- clinical or anamnestic pointer to actual malignant disease or bone metastasis
- indication for surgery according to orthopedic judgement
- alcoholic disease
- cachexia (BMI ≤18,0)

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Addresses

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    • Abt. f. Naturheilkunde, Klinik Blankenstein, ,
    • Mr.  Prof. Dr. med.  André-Michael  Beer 
    • Im Vogelsang 5
    • 45527   Hattingen
    • Germany
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    • Department of True Naturopathy, Blankenstein Hospital, Hattingen, Germany
    • Mr.  Prof. Dr.  André-Michael  Beer 
    • Im Vogelsang 5-11
    • 47  Hattingen
    • Germany
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    • Abt. f. Naturheilkunde, Klinik Blankenstein, ,
    • Mr.  Prof. Dr. med.  André-Michael  Beer 
    • Im Vogelsang 5
    • 45527   Hattingen
    • Germany
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Sources of Monetary or Material Support

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    • Abt. für Naturheilkunde, Klinik Blankenstein
    • Im Vogelsang 5-11
    • D-45527  Hattingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/26
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.