Trial document





This trial has been registered retrospectively.
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  DRKS00006887

Trial Description

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Title

The influence of a SOC-oriented coaching and physiotherapy on health and work ability in nurses with non-specific musculoskeletal complaints

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Trial Acronym

CoPA

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URL of the Trial

http://www.uniklinik-duesseldorf.de/unternehmen/institute/institut-fuer-arbeitsmedizin-und-sozialmedizin/forschung/projekte/

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Brief Summary in Lay Language

Nurses belong to a professional group with an increased risk of musculoskeletal complaints, which are related to their physical and psychological job demands. A randomized controlled trial will be conducted to evaluate the effect of the combination of physiotherapy and coaching on musculoskeletal complaints, and work ability in comparison to physiotherapy alone.

110 nurses with non-specific musculoskeletal complaints (n = 55 control group (CG), n = 55 intervention group (IG)) will receive 10 individual focussed physiotherapy-sessions. The IG will additionally receive one psychoeducational group-session about the SOC-model, and five single-coaching-sessions. Within the coaching stressful work situations will be reflected, and optimized action strategies will be developed to cope better with work stress.

Amendment (2016.01.12):
Every participant pass again one physical investigation as well as a questionnaire survey.

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Brief Summary in Scientific Language

Nurses belong to a professional group with an increased risk of musculoskeletal complaints. From a biopsychosocial perspective a randomized controlled trial will be conducted to evaluate the effect of the combination of physiotherapy and SOC-oriented coaching on musculoskeletal complaints, and work ability in nurses compared to physiotherapy alone.

110 nurses with non-specific musculoskeletal complaints (n = 55 control group (CG), n = 55 intervention group (IG)) will receive 10 individual focussed physiotherapy-sessions in small groups (45 minutes). The IG will additionally receive one psychoeducational group-session about the SOC-model, and five single-coaching-sessions. Within the coaching stressful work situations will be reflected, and optimized action strategies will be developed to cope better with work stress.

Musculoskeletal complaints will be measured by physical examination at the beginning and end of the intervention according to Spallek et al., (2007), by the Nordic Questionnaire (Kuorinka et al. 1987), and the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) (Kerns et al. 1985).
Work ability will be measured with the German version of the Work Ability Index (WAI, Hasselhorn & Freude 2007).

Amendment (2016.01.12):
Every participant pass again one physical investigation as well as a questionnaire survey.

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Organizational Data

  •   DRKS00006887
  •   2014/11/07
  •   [---]*
  •   yes
  •   Approved
  •   4537R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   non-specific musculoskeletal complaints at shoulder, back, neck
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Interventions/Observational Groups

  •   The control group will receive 10 sessions physiotherapy within 10 weeks (once a week for 45 minutes) in small groups.


  •   The intervention group will receive 10 sessions physiotherapy like arm 1, one psychoeducational group-session about the SOC-model (90 min), five 90-minutes single-coaching-sessions and one group-session review SOC-model (90 min).
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Characteristics

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

The effectiveness is measured primarily by musculoskeletal complaints. The physical examination is implemented at the beginning and end of the intervention according to Spallek et al., (2007) [measuring times: baseline, after 12 weeks and 24 months], by the Nordic Questionnaire (Kuorinka et al. 1987) [measuring times: baseline, after 12, 22 weeks and 24 months], and pain by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) (Kerns et al. 1985) [measuring times: baseline, after 2, 4, 6, 8, 10, 12, 22 weeks and 24 months].

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Secondary Outcome

Secondary end points are the use of SOK strategies, work ability, health-related quality of life and mental well-being.

Questionnaires:
- short form SOC-questionnaire (Baltes, Baltes, Freund, & Lang, 1999): SOK strategies [measuring times: baseline, after 12, 22 weeks and 24 months]
- Questionnaire for SOC strategies in nursing (Müller et al. 2013): SOK strategies [measuring times: baseline, after 12, 22 weeks and 24 months]
- Short form SF 36 health questionnaire (SF 12) (Ware, Sherbourne 1992): health-related quality of life [measuring times: baseline, after 12, 22 weeks and 24 months]
- German version of the Work Ability Index (WAI, Hasselhorn & Freude 2007). Measuring times: Baseline, after 2, 4, 6, 8, 10, 12, 22 weeks and 24 months.
- Maslach Burnout Inventory (MBI, Maslach & Jackson 1981): burnout; mental well-being [measuring times: baseline, after 2, 4, 6, 8, 10, 12, 22 weeks and 24 months]
- Irritation (Mohr, Rigotti & Müller 2005): mental well-being [measuring times: baseline, after 2, 4, 6, 8, 10, 12, 22 weeks and 24 months]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/04/14
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Certified nurses working in hospitals with at least one episode of musculoskeletal complaints (back, shoulder, neck) during the last 2 years are suitable for the study.

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Exclusion Criteria

Nurses with acute specific complaints are excluded.

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Addresses

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    • Institut für Arbeitsmedizin und Sozialmedizin, Heinrich-Heine-Universität
    • Universitätsstraße 1
    • 40225  Düsseldorf
    • Germany
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    • Institut für Arbeitsmedizin und Sozialmedizin, Heinrich Heine Universität Düsseldorf
    • Mr.  Prof. Dr. med.  Peter  Angerer 
    • Universitätsstraße 1
    • 40225  Düsseldorf
    • Germany
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    • Institut für Arbeitsmedizin und Sozialmedizin, Heinrich Heine Universität Düsseldorf
    • Ms.  Annette  Becker 
    • Universitätsstraße 1
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege
    • Pappelallee 33/35/37
    • 22089  Hamburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/30
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* This entry means the parameter is not applicable or has not been set.