Integrative Medicine for Chronic Pain

Chronic Pain Clinical Trial

— POSITIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038244
• Other study ID #: 135393-BO
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: September 22, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Universität Duisburg-Essen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Multimodal integrative medicine inpatient treatment program

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body awareness	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)	14 days, 6 months	No
Other	Body responsiveness	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)	14 days, 6 months	No
Other	Body awareness and dissociation	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)	14 days, 6 months	No
Other	Postural awareness	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.)	14 days, 6 months	No
Other	Body awareness	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)	14 days, 6 months	No
Other	Daily log	Daily rating of pain and well-being on a 100mm visual analog scale.	2 weeks	No
Primary	Pain Intensity	VAS	14 days	No
Secondary	Pain Intensity	VAS	6 months	No
Secondary	Pain Disability	- German Pain Questionnaire	14 days, 6 months	No
Secondary	Health-related quality of life	Short Form (36) Health Survey	14 days, 6 months	No
Secondary	Life satisfaction	Brief Multidimensional Life Satisfaction Scale	14 days, 6 months	No
Secondary	Depression	Beck Depression Inventory	14 days, 6 months	No
Secondary	Acceptance	Emotional/Rational Disease Acceptance Questionnaire	14 days, 6 months	No
Secondary	Mindfulness	Conscious Presence and Self Control (CPSC) Scale	14 days, 6 months	No
Secondary	Subjective stress	Perceived Stress Scale	14 days, 6 months	No
Secondary	Easiness of life	Questionnaire on emotional and physical reactions	14 days, 6 months	No
Secondary	Ability and will to change	Ability and will to change Questionnaire	14 days, 6 months	No
Secondary	Safety	Adverse events	14 days, 6 months	Yes
Secondary	Pain Disability	- Pain Disability Index	14 days, 6 months	No