Effects of Multimodal Pain Therapy in Patients With Mixed... | NCT01346202

Studies
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes

NCT01346202

Sponsor

Klinikum St. Georg gGmbH

Status

Completed

Last Update Posted

Jul 15, 2013Estimated

Enrollment

260Actual

Phase

Not provided

Conditions

Chronic Pain

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2013

Last Update Posted Date

Jul 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The multi-modal pain therapy includes:

specific drug therapy
pain education
psychological therapy
physical therapy
behavioral therapy
work hardening
bio-feedback
ergotherapy

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic pain		260 consecutive patients with verified chronic pain syndromes

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
pain disability index	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

260 consecutive patients with chronic pain syndromes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin R Sablotzki, MD, PhD	Klinikum St. Georg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum St. Georg, Pain Center		Leipzig	Saxony	04129	Germany

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided