- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346202
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes (IMPERApain)
July 12, 2013 updated by: Armin Sablotzki, MD, Klinikum St. Georg gGmbH
Influence of a Multimodal Day-unit Pain Therapy on Pain Experience, Pain-related Disability and Depression in Patients With Chronic Pain Syndromes
Complex and chronified pain syndromes requires a specialized therapeutic concept.
From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success.
In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.
Study Overview
Status
Completed
Conditions
Detailed Description
The multi-modal pain therapy includes:
- specific drug therapy
- pain education
- psychological therapy
- physical therapy
- behavioral therapy
- work hardening
- bio-feedback
- ergotherapy
Study Type
Observational
Enrollment (Actual)
260
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sachsen
-
Leipzig, Sachsen, Germany, 04129
- Klinikum St. Georg, Pain Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
260 consecutive patients with chronic pain syndromes
Description
Inclusion Criteria:
- age >= 18 years and <= 65 years
- verified chronic pain for more than 6 month
Exclusion Criteria:
- application for a pension
- non-accordance with multi-modal pain therapy
- dominant geriatric symptoms
- dominant psychiatric symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
chronic pain
260 consecutive patients with verified chronic pain syndromes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intensity of pain
Time Frame: Change from Baseline in intensity of pain at 1 year
|
pain intensity 1 year after multi-modale therapy compared with pain intensity before treatment
|
Change from Baseline in intensity of pain at 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain disability index
Time Frame: Change from Baseline in pain disability index at 6 months
|
pain disability index 6 month after multi-modale therapy compared with pain disability index before treatment
|
Change from Baseline in pain disability index at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Armin R Sablotzki, MD, PhD, Klinikum St. Georg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
April 27, 2011
First Submitted That Met QC Criteria
April 29, 2011
First Posted (Estimate)
May 2, 2011
Study Record Updates
Last Update Posted (Estimate)
July 15, 2013
Last Update Submitted That Met QC Criteria
July 12, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-BR-28/10-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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