Trial document





This trial has been registered retrospectively.
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  DRKS00000460

Trial Description

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Title

Effectiveness of mindfulness meditation for 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 mindfulness meditation for neck pain/ cervical spine pain and co-existing stress. Participants will be randomized to - an 8-week meditation program with recommendation to continue this at home daily or - an 8-week neck/ cervical spine exercises control program with offer for the meditation training afterwards. There are questionnaires to fill out and saliva samples to provide (determination of the cortisol concentration) -before the first training begins (baseline) and after 8 weeks (end line). The effect of meditation on neck pain/ cervical spine pain will be compared to the result of the control group.

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Brief Summary in Scientific Language

The objective of this controlled randomized monocentric clinical trial is to evaluate the effectiveness of meditation versus control group - an 8-week neck/ cervical spine exercises control program with offer for the meditation training afterwards - in patients with chronic neck pain and co-existing stress. Primary endpoint is pain intensity measured by VAS. Several secondary endpoints include validated questionnaires for function, disability and general well-being.

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Organizational Data

  •   DRKS00000460
  •   2010/08/13
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  •   yes
  •   Approved
  •   Antragsnummer: EA4/029/10, 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: Mindfulness easily learned meditation: an 8-week meditation program with recommendation to continue this at home daily.

  •   Control group: an 8-week back exercises control program with offer for the meditation 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

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Secondary Outcome

- Cohen Perceived Stress Scale
- 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);
- Affective pain assessment („SES“);
- Intensity / frequency of analgesic basic medication and demand medication (diary);
- Mood, fear, depression (ADS, POMS, HADS. STAI);
- Maslach Burnout Inventory (MBI)
- Meditation Depth Questionnaire (MEDEQ) by Piron/Ott
- Blood pressure, systolic and diastolic
- Heart rate
- Adherence with the meditation program and the everyday practice recommendation


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/04/20
  •   55
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Patients an age between 18 to 65 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
4. Existing stress with a predefined CPSS-Score or with a minimum of 35 mm on VAS - subjectively felt stress intensity in the everyday life of the last week - from 0 to 100 mm
5. Original dated and signed patient information, informed consent forms

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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
- Cervical spine syndrome/ whiplash injury

- Rheumatoid arthritis

- Acute mental illness

- Serious pathology, somatic diseases
- pregnancy
- Regularly exercised mindfulness meditation/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
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Else Kröner-Fresenius-Stiftung
    • Am Rilgerrain 15
    • 61352   Bad Homburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/03/24
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Trial Publications, Results and other Documents

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