Integrative Medicine for Chronic Pain (POSITIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Multimodal integrative medicine inpatient treatment program

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Medicine	Other: Multimodal integrative medicine inpatient treatment program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	VAS	14 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Daily log	Daily rating of pain and well-being on a 100mm visual analog scale.	2 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: University of Witten/Herdecke

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 135393-BO