Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005934

Trial Description

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Title

Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine

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Trial Acronym

POSITIVE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for
integrative medicine on pain, disability, quality of life, satisfaction with life,
depression, and anxiety will be investigated. Furthermore the influence of potential process
variables will be evaluated.

Effects will be measured after completion of the program (2 weeks), and at 6 months follow
up after start of the program.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005934
  •   2014/07/11
  •   2014/01/09
  •   yes
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Secondary IDs

  •   NCT02038244  (ClinicalTrials.gov)
  •   135393-BO  (Universität Duisburg-Essen)
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Health Condition or Problem studied

  •   Chronic Pain
  •   R52 -  Pain, not elsewhere classified
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Interventions/Observational Groups

  •   Other: Multimodal integrative medicine inpatient treatment program
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

- Pain Intensity; time frame: 14 days; VAS

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Secondary Outcome

- Pain Intensity; time frame: 6 months; VAS
- Pain Disability; time frame: 14 days, 6 months; - German Pain Questionnaire
- Health-related quality of life; time frame: 14 days, 6 months; Short Form (36) Health Survey
- Life satisfaction; time frame: 14 days, 6 months; Brief Multidimensional Life Satisfaction Scale
- Depression; time frame: 14 days, 6 months; Beck Depression Inventory
- Acceptance; time frame: 14 days, 6 months; Emotional/Rational Disease Acceptance Questionnaire
- Mindfulness; time frame: 14 days, 6 months; Conscious Presence and Self Control (CPSC) Scale
- Subjective stress; time frame: 14 days, 6 months; Perceived Stress Scale
- Easiness of life; time frame: 14 days, 6 months; Questionnaire on emotional and physical reactions
- Ability and will to change; time frame: 14 days, 6 months; Ability and will to change Questionnaire
- Safety; time frame: 14 days, 6 months; Adverse events
- Pain Disability; time frame: 14 days, 6 months; - Pain Disability Index

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/02/27
  •   300
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Inclusion Criteria

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

- diagnosed with any chronic pain condition

- at least 6 months pain duration

- written informed consent

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Exclusion Criteria

- participation in any other clinical study

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Addresses

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    • Universität Duisburg-Essen
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    • University of Witten/Herdecke
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    • Holger Cramer, PhD 
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    • Holger Cramer, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.