Cost of Long Term Disability in Patients With Chronic Non... | NCT00652236

Studies
Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain

NCT00652236

Sponsor

Klinik Valens

Status

Terminated

Last Update Posted

Apr 3, 2008Estimated

Enrollment

174Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

Physiotherapy

Countries

Switzerland

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

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated according the study protocol end of 2007

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

Mar 27, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 3, 2008Estimated

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

Mar 31, 2008

Last Update Posted Date

Apr 3, 2008Estimated

Name	Class
University of Applied Sciences of Western Switzerland	OTHER
Zurich University of Applied Sciences	OTHER

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

The purpose of the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect costs were recorded by questionnaires sent to health insurances, employers and Swiss Disability Insurance Company.

Detailed Description

Not provided

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

174Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FCT		Patients passing a function- centred rehabilitation	Other: Physiotherapy
PCT		Patients passing a pain-centred rehabilitation	Other: Physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other	The two groups passed an in-patient rehabilitation and a physiotherapy: FCT function-centred vs. PCT pain-centred	FCT PCT

Measure	Description	Time Frame
cost- effectiveness		3 year follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic low back pain, sick leave of 6 weeks during the last 6 months

Exclusion Criteria:

not able to perform a training program

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Tertiary rehabilitaton centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Bachmann, MD	Rehabilitationszentrum Klinik Valens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rehabilitationszentrum Klinik Valens		Valens	Canton of St. Gallen	CH- 7317	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided