Trial document




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  DRKS00009258

Trial Description

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Title

Effectiveness of Osteopathy in Professional Musicians (Violinists and Violists) 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

Chronic neck pain is one of the most common problems of high string players which generates high costs in the health system and can lead to occupational disability. It is so far unclear which treatment is the most effective.
The objective of the study is to evaluate the effectiveness of an osteopathic treatment in professional musicians (violinists and violists) with chronic neck pain in comparison to a control group. All participants will get a consultation considering playing related problems immediately after inclusion and 5 osteopathic treatment within 10 weeks randomly either immediately after inclusion to the study or after 12 weeks.

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Brief Summary in Scientific Language

Aim: The aim of this study is to evaluate the effectiveness, safety and cost-effectiveness of an osteopathic treatment in addition to a consultation considering playing related problems of musicians and a rescue medication of 500 mg Paracetamol up to 4 times daily (intervention group) in comparison to a control group with a consultation considering playing related problems of musicians and a permitted rescue medication of 500 mg Paracetamol up to 4 times daily (control group) in professional orchestral musicians, soloists or music students (violinists and violists) with chronic neck pain.
Design: Two armed randomized controlled trial
Participants: 100 professional musicians (18-65 years of age) with chronic neck pain.
Intervention: After inclusion and before randomization all participants will get a 45 minute consultation considering playing related problems of musicians and a related handout. After randomization participants of the intervention group will receive 5 osteopathic treatment sessions 45-60 minutes each in two weeks interval. Patients of the control group will receive no osteopathic treatment sessions in the first 12 weeks. After 12 weeks patients of this group will also receive osteopathic treatment sessions if requested. A rescue medication of 500 mg Paracetamol is permitted in the first 12 weeks.
Outcome measures: The primary outcome is the subjective perceived neck pain on a visual analogue scale (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain) measured after 12 weeks. Secondary outcomes include the subjective perceived neck pain on a visual analogue scale VAS after 6, 26 and 52 weeks, further secondary outcomes measured by questionnaires after 6, 12, 26 and 52 weeks each are the Neck Disability Index (NDI), the visual analogue scale for perceived pain (VAS, 0-100mm), the SF-12 health related quality of life, days of disability due to musculoskeletal pain, medication intake (analgesics) and inability to work due to musculoskeletal pain within the last 7 days, playing related disability, safety, cost and cost effectiveness.

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Organizational Data

  •   DRKS00009258
  •   2015/08/24
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  •   yes
  •   Approved
  •   EA 1/198/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   M99.01 -  [generalization M99.0: Segmental and somatic dysfunction]
  •   M54.2 -  Cervicalgia
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Interventions/Observational Groups

  •   After inclusion and before randomization the participants will get a 45 minute consultation considering playing related problems of musicians and a related handout. After randomization participants of the intervention group will receive 5 osteopathic treatment sessions 45-60 minutes each in two weeks interval. A rescue medication of 500 mg Paracetamol up to 4 times daily is permitted in the first 12 weeks.
  •   After inclusion and before randomization all participants will get a 45 minute consultation considering playing related problems of musicians and a related handout.
    Patients of the controll group (n=50) will get no osteopathic treatment within the first 12 weeks. After 12 weeks Patients of this group can get osteopathic treatment if wished. A rescue medication of 500 mg Paracetamol up to 4 times daily is permitted.
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Characteristics

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

The primary outcome is the subjective perceived neck pain on a visual analogue scale (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain) measured after 12 weeks.

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Secondary Outcome

Secondary outcomes include the subjective perceived neck pain on a visual analogue scale VAS after 6, 26 and 52 weeks, further secondary outcomes measured by questionnaires after 6, 12, 26 and 52 weeks each are the Neck Disability Index (NDI), the visual analogue scale for perceived pain (VAS, 0-100mm), the SF-12 health related quality of life, days of disability due to musculoskeletal pain, medication intake (analgesics) and inability to work due to musculoskeletal pain within the last 7 days, playing related disability, safety, cost and cost effectiveness.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/21
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- active professional professional orchestral musicians, soloists or music students (violinists and violists)
- 18 to 65 years of age
- Proved clinical diagnosis "chronic neck pain", i.e. neck pain for at least 12 weeks
- intensity of the average neck pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS)
- within the last 4 weeks before inclusion treatment against neck pain was only by medicaments
- willingness to get a consultation considering playing related problems of musicians and 5 osteopathic treatments within the next 10 weeks
- willingness to to do without osteopathic treatment within the next 12 weeks in case of randomization to control group
- ability to give oral and signed written informed consent
- written and oral informed consent

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Exclusion Criteria

- peripher or central neurological symptoms
- known vascular anomaly such as aneurysm
- known or suspected primary or secondary bone tumor
- neck pain caused by recent trauma
- rheumatic diseases
- prior surgery on cervical column
- suspected osteoporosis
- osteopathic treatment within the last 6 month before beginn of study
- neck pain treated by complementary medicine actual or within the last 3 month before inclusion
- neck pain treated by physical medicine actual or within the last 3 month before inclusion
- obesity with BMI >30 Kg/m2
- intake of centrally acting analgesics
- pregnancy
- severe acute and or chronic disease which does not allow participation in the therapy
- other limitations which do not allow participation in the therapy
- alcohol or substance abuse
- planed or actual using of therapies with positive impact on chronic neck pain - like physiotherapy, acupuncture, massage, neuroreflex therapy, Feldenkrais during study paritipation
- no sufficient knowledge of German language
- current application for a benefit
- participation in another clinical trial during six months before the study and parallel to the study
- absence of written informed consent

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Addresses

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    • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin
    • Luisenstrasse 57
    • 10117  Berlin
    • Germany
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    • Institut für Sozialmedizin, Epidemiologie und Gesund- heitsökonomie,ChariteĢ – Universitätsmedizin Berlin
    • Ms.  Dr. med.  Gabriele  Rotter 
    • Luisenstrasse 57
    • 10117  Berlin
    • Germany
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    • Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
    • Ms.  Margit  Cree 
    • Luisenstrasse 57
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
    • Luisenstrasse 57
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/08
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Trial Publications, Results and other Documents

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