Trial document




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  DRKS00004651

Trial Description

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Title

The treatment of chronic back pain through non-pharmacological intervention procedures:
Comparison of efficacy of eurythmy therapy, yoga and standard physio therapy

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Trial Acronym

YES

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URL of the Trial

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Brief Summary in Lay Language

The effectiveness of physiotherapy in the treatment of chronic back pain treatments is generally accepted. We intend to investigate whether also physical interventions which included elements of `meditation´, such as yoga or therapeutic eurythmy, might be beneficial.
The purpose of the study is thus to investigate whether these methods in fact have beneficial effects on chronic back pain, whether or not these interventions differ with respect to the outcomes, and which variables may have a significant impact.
Chronic pain syndromes, particularly chronic back pain, represent a dramatically increasing problem in medical care. Apart of direct effects of chronic pain such as decreased functioning, mobility and working ability, the continued experience of pain results in significant experience of stress and impairment of quality of life. Conventional treatment options are limited. Analgesics and pain medication are not optimal for long term application because of their well-known side effects.
Since several years, non-pharmacological treatment options enrolling different movement methods were investigated. These include standard physical therapy with exercise and walking, as well as yoga exercises from Indian medicine, and therapeutic eurhythmy from Anthroposophic Medicine. In Integrative Medicine, yoga was meanwhile evaluated in randomized controlled studies as a complementary holistic movement intervention. However, there are currently no data from comparative studies which would allow an assessment of the respective treatment effects.

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Brief Summary in Scientific Language

Chronic pain syndromes, particularly chronic back pain, represent a dramatically increasing problem in medical care. Apart of direct effects of chronic pain such as decreased functioning, mobility and working ability, the continued experience of pain results in significant experience of stress, impairment of quality of life, and various vegetative affections.Conventional treatment options are limited. Analgesics and pain medication are not optimal for long term application because of their well-known side effects. Non-pharmacological therapies are well established and include physical therapy, physiotherapy, and psychosomatic therapy. In Anthroposophic Medicine, on the basis of data from uncontrolled studies and also expert recommendations, the application of therapeutic eurythmy is encouraged as an effective intervention to treat chronic back pain. However, reliable data from randomized controlled trials are still lacking. In Integrative Medicine, yoga was meanwhile evaluated in randomized controlled studies as a complementary holistic movement intervention. With respect to the overall positive study outcomes when compared to standard exercise therapy, in the Anglo-American region yoga is implemented in guidelines recommendations first.Within the intended three-arm randomized controlled trial, 270 patients with chronic back pain will be examined for 16 weeks. Patients will be treated actively for 8 weeks either with therapeutic eurythmy, yoga or standard physiotherapy. At the start of the intervention, at the end of the 8 week active phase, and after a further 8 week observation period, patients will be investigated with internationally validated and clinically relevant parameters (primary outcome variable: functional disability due to pain, week 8; secondary outcome variables: intensity of pain, quality of life and well-being, perceived stress, etc.). We suggest therapeutic eurythmy and yoga as equally effective, more effective when compared to standard physiotherapy.The results of the project are intended to provide evidence that yoga and therapeutic eurythmy might be a rationale in the regular treatment of patients with chronic pain conditions. Aim of the project is thus the international establishment of therapeutic eurythmy and yoga as optional interventions in the treatment of chronic pain syndrome.

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Organizational Data

  •   DRKS00004651
  •   2013/03/22
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  •   yes
  •   Approved
  •   EA4/074/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   M54.5 -  Low back pain
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Interventions/Observational Groups

  •   Therapeutic eurythmy
    -> once a week for 75 minutes during 8 weeks (=8x) (=10h)
  •   Therapeutic yoga
    -> once a week for 75 minutes during 8 weeks (=8x) (=10h)
  •   physiotherapy
    -> once a week for 75 minutes during 8 weeks (=8x) (=10h)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of the efficacy of three interventions, i.e., yoga, therapeutic eurythmy and standard physiotherapy within a randomised controlled study enrolling 270 patients with back pain for 8 weeks plus an 8 obervation phase) with standardized questionnaires:
Roland-Morris-Disability Score (functional disabiliy due to chronic pain)
at basline, end of intervention (after 8 weeks), and at the end of the observation period (16 weeks)

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Secondary Outcome

- Pain intensity (visual analogue scale, VAS, rating scale)
- affections by pain (VAS, "Bothersomeness")
- Quality of life (SF-12)
- Life satisfaction (BMLSS)
- Well- Being (ASTS) -> positive mood subscale
- Stress perception (Cohen´s Perceived Stress Scale)
at basline, end of intervention (after 8 weeks), and at the end of the observation period (16 weeks)
- Usage of analgesic medication (Diary documentation)
=> recorded during the whole observation period (16 weeks)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/02/27
  •   270
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- Duration of back pain > / = 3 months
- Intensity of back pain> / = 40mm to 100mm VAS
- Legal capacity
- Consent to participate and questionnaire filling

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Exclusion Criteria


- acute herniated disk (<3 months) or herniated disc with surgical indication
- tumors with bone metastases
- other currently active, non-pharmacological treatments (Inlusion only if 3 months previously), excepted back therapy training
- participation in other clinical trials or observational study within the last 4 weeks
- acute psychiatric disorders (depression, psychosis, etc.) which may limit the study validity

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Addresses

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    • Charite Universitätsmedizien- Berlin und Immanuel Diakonie Group Berlin
    • Mr.  Univ.-Prof. Dr. med.  Andreas  Michalsen 
    • Königsstrasse 63
    • 14109  Berlin
    • Germany
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    • Zentrum für Integrative Medizin Fakultät für Gesundheit der Universität Witten Herdecke Gemeinschaftskrankenhaus Herdecke
    • Mr.  Univ.-Prof. Dr. med.  Arndt  Büssing 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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    • Forschungsinstitut Havelhöhe Gemeinschaftskrankenhaus Havelhöhe
    • Mr.  Dr. med.  Matthias   Kröz 
    • Kladower Damm 221
    • 14089  Berlin
    • Germany
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    • Charite Universitätsmedizien- Berlin und Immanuel Diakonie Group Berlin
    • Mr.  Univ.-Prof. Dr. med.  Andreas  Michalsen 
    • Königsstrasse 63
    • 14109  Berlin
    • Germany
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    • Hochschulambulanz für Naturheilkunde der Charite-Universitätsmedizin in Berlin im Immanuel Krankenhaus Berlin
    • Ms.  Sabine  Saalfeld 
    • Am Kleinen Wannsee 5 D
    • 14109  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Software Ag Stiftung
    • Mr.  Dirg Lothar  Ollinger 
    • Am Eichwäldchen 6
    • 64297   Darmstadt
    • Germany
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    • DAMUS e.V.
    • Mr.  Dr.   Benediktus  Hardorp 
    • PF 101440
    • 68014  Mannheim
    • Germany
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    • Mahle Stiftung
    • Mr.  Lerch 
    • Leibnitzstr. 35
    • 70193   Stuttgart
    • Germany
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    •   0049 711 6364331
    •   0049 630793
    •   [---]*
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    • GLS Bank
    • Mr.  Thomas  Jorberg 
    • Christstr. 9
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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