Trial document





This trial has been registered retrospectively.
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  DRKS00000454

Trial Description

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Title

Effectiveness of Yoga in patients with chronic neck pain. A randomized controlled trial.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this randomized controlled trial is to verify the effects of a regularly exercised Iyengar Yoga training program for neck pain/ cervical spine pain. Participants will be randomized to - a 9-week Iyengar Yoga exercise program with recommendation to continue this at home daily or – a 9-week neck, cervical spine exercises control program with offer for the Iyengar Yoga training afterwards. There are questionnaires to fill out before the first training begins (baseline), after 4 weeks and after 9 weeks (end line).

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Brief Summary in Scientific Language

The objective of this controlled randomized monocentric clinical trial is to evaluate the effectiveness of easily learned 9-week Yoga training program versus control group – a 9-week neck and cervical spine exercises control program with offer for the Yoga training afterwards - in patients with chronic neck pain/ cervical spine pain.

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Organizational Data

  •   DRKS00000454
  •   2011/04/01
  •   [---]*
  •   yes
  •   Approved
  •   EA4/010/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   M54.2 -  Cervicalgia
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Intervention group: classical yoga exercises with elements of Iyengar yoga: an 9-week yoga program (90 min. each week) with recommendation to continue this at home daily.
  •   Control group: an 9-week neck and cervical spine exercises exercises control program with offer for the yoga training afterwards.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
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Primary Outcome

100 mm VAS for average neck pain/cervical spine pain intensity during the last week, baseline (week 0) versus end (week 9).

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Secondary Outcome

Baseline (week 0) versus end (week 9):

- Neck Pain disability (NPAD)-Index
- 100 mm VAS for the global average interference by neck pain („bothersomeness“) during the last week;
- VAS: arm/ shoulder pain
- VAS: headache
- Short Form 36 Health Survey (SF-36)
- Overall assessment of the effectiveness and compatibility (Likert scale);
- Mood, fear, depression (ADS, POMS, HADS. STAI);
- Affective pain assessment („SES“);
- Intensity / frequency of analgesic basic medication and demand medication (diary).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/02/19
  •   56
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Patients an age between 18 to 60 years
2. Pre-existing diagnosis of cervical syndrome with chronic neck pain/ cervical spine pain established by a specialist (orthopaedics, neurology, pain therapy) since at least 3 months
3. Average neck pain/ cervical spine pain intensity with a minimum of 40 mm on VAS from 0 to 100 mm and pains in least 5 of 7 weekdays during the last 3 months

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Exclusion Criteria

-Invasive treatments in the cervical spine within the last 6 weeks or planned within the next 10 weeks
- Acute prolapse of intervertebral disk (diagnosis within the last 3 months)
- Congenital anomalies in the cervical spine area
-serious limitation of shoulder movements/ “Frozen shoulder-syndrome“
- Cervical spine syndrome/ whiplash injury
- Rheumatoid arthritis
- Acute mental illness
- Serious comorbidity
- pregnancy
- Regularly practiced Iyengar yoga
- Concurrent participation in another clinical study

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Addresses

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    • Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
    • Ms.  Larissa  Meier 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Immanuel Krankenhaus Berlin-Wannsee
    • Königstr. 63
    • 14109  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/08/30
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Trial Publications, Results and other Documents

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