NCT02038244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

January 9, 2014

Last Update Submit

September 22, 2015

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    VAS

    14 days

Secondary Outcomes (12)

  • Pain Intensity

    6 months

  • Pain Disability

    14 days, 6 months

  • Health-related quality of life

    14 days, 6 months

  • Life satisfaction

    14 days, 6 months

  • Depression

    14 days, 6 months

  • +7 more secondary outcomes

Other Outcomes (6)

  • Body awareness

    14 days, 6 months

  • Body responsiveness

    14 days, 6 months

  • Body awareness and dissociation

    14 days, 6 months

  • +3 more other outcomes

Study Arms (1)

Integrative Medicine

EXPERIMENTAL
Other: Multimodal integrative medicine inpatient treatment program

Interventions

Multimodal integrative medicine inpatient treatment programOTHER
Integrative Medicine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with any chronic pain condition
  • at least 6 months pain duration
  • written informed consent

You may not qualify if:

  • participation in any other clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 16, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-05

Locations

DE(1)