Integrative Medicine for Chronic Pain (POSITIVE)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Multimodal integrative medicine inpatient treatment program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- diagnosed with any chronic pain condition
- at least 6 months pain duration
- written informed consent
Exclusion Criteria:
- participation in any other clinical study
Sites / Locations
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrative Medicine
Arm Description
Outcomes
Primary Outcome Measures
Pain Intensity
VAS
Secondary Outcome Measures
Pain Intensity
VAS
Pain Disability
- German Pain Questionnaire
Health-related quality of life
Short Form (36) Health Survey
Life satisfaction
Brief Multidimensional Life Satisfaction Scale
Depression
Beck Depression Inventory
Acceptance
Emotional/Rational Disease Acceptance Questionnaire
Mindfulness
Conscious Presence and Self Control (CPSC) Scale
Subjective stress
Perceived Stress Scale
Easiness of life
Questionnaire on emotional and physical reactions
Ability and will to change
Ability and will to change Questionnaire
Safety
Adverse events
Pain Disability
- Pain Disability Index
Full Information
NCT ID
NCT02038244
First Posted
January 9, 2014
Last Updated
September 22, 2015
Sponsor
Universität Duisburg-Essen
Collaborators
University of Witten/Herdecke
1. Study Identification
Unique Protocol Identification Number
NCT02038244
Brief Title
Integrative Medicine for Chronic Pain
Acronym
POSITIVE
Official Title
Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
University of Witten/Herdecke
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrative Medicine
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Multimodal integrative medicine inpatient treatment program
Primary Outcome Measure Information:
Title
Pain Intensity
Description
VAS
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
VAS
Time Frame
6 months
Title
Pain Disability
Description
- German Pain Questionnaire
Time Frame
14 days, 6 months
Title
Health-related quality of life
Description
Short Form (36) Health Survey
Time Frame
14 days, 6 months
Title
Life satisfaction
Description
Brief Multidimensional Life Satisfaction Scale
Time Frame
14 days, 6 months
Title
Depression
Description
Beck Depression Inventory
Time Frame
14 days, 6 months
Title
Acceptance
Description
Emotional/Rational Disease Acceptance Questionnaire
Time Frame
14 days, 6 months
Title
Mindfulness
Description
Conscious Presence and Self Control (CPSC) Scale
Time Frame
14 days, 6 months
Title
Subjective stress
Description
Perceived Stress Scale
Time Frame
14 days, 6 months
Title
Easiness of life
Description
Questionnaire on emotional and physical reactions
Time Frame
14 days, 6 months
Title
Ability and will to change
Description
Ability and will to change Questionnaire
Time Frame
14 days, 6 months
Title
Safety
Description
Adverse events
Time Frame
14 days, 6 months
Title
Pain Disability
Description
- Pain Disability Index
Time Frame
14 days, 6 months
Other Pre-specified Outcome Measures:
Title
Body awareness
Description
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.
- Body Awareness Questionnaire (BAQ) (Shields 1989)
Time Frame
14 days, 6 months
Title
Body responsiveness
Description
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.
Body Responsiveness Scale (BRS)(Daubenmier 2005)
Time Frame
14 days, 6 months
Title
Body awareness and dissociation
Description
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.
- Scale of Body Connection (SBC) (Price and Thompson 2007)
Time Frame
14 days, 6 months
Title
Postural awareness
Description
Newly developed body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.
- Postural Awareness Scale (PAS) (Cramer et al.)
Time Frame
14 days, 6 months
Title
Body awareness
Description
The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes.
- Dresden Body Image Questionnaire (DKB) (Pöhlmann et al., 2007)
Time Frame
14 days, 6 months
Title
Daily log
Description
Daily rating of pain and well-being on a 100mm visual analog scale.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with any chronic pain condition
at least 6 months pain duration
written informed consent
Exclusion Criteria:
participation in any other clinical study
Facility Information:
Facility Name
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
City
Essen
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Integrative Medicine for Chronic Pain
We'll reach out to this number within 24 hrs