NCT01346202

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

2.5 years

First QC Date

April 27, 2011

Last Update Submit

July 12, 2013

Conditions

Chronic Pain

Keywords

multi-modal pain therapy, chronic pain

Outcome Measures

Primary Outcomes (1)

  • intensity of pain

    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 Outcomes (1)

  • pain disability index

    Change from Baseline in pain disability index at 6 months

Study Arms (1)

chronic pain

260 consecutive patients with verified chronic pain syndromes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

260 consecutive patients with chronic pain syndromes

You may qualify if:

  • age \>= 18 years and \<= 65 years
  • verified chronic pain for more than 6 month

You may not qualify if:

  • application for a pension
  • non-accordance with multi-modal pain therapy
  • dominant geriatric symptoms
  • dominant psychiatric symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum St. Georg, Pain Center

Leipzig, Saxony, 04129, Germany

Location

Related Links

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Armin R Sablotzki, MD, PhD

    Klinikum St. Georg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 27, 2011

First Posted

May 2, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

DE(1)