Biopsychosocial Education and Chronic Low Back Pain | NCT00600197

Studies
Biopsychosocial Education and Chronic Low Back Pain

NCT00600197

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 18, 2009Estimated

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Chronic Low Back Pain

Interventions

back school

Countries

Iran

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

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Apr 2010Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Jan 13, 2008

First Submission Date that Met QC Criteria

Jan 13, 2008

First Posted Date

Jan 24, 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

Nov 17, 2009

Last Update Posted Date

Nov 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.

Detailed Description

Little information exists on biopsychosocial educational program as a multidimensional and interdisciplinary program in which Quality Of Life is as an outcome measure. Thus this educational Program designed in this study is a an outpatient program that used a health education approach to empower participants through a process of assessment, education and skill building in three dimensions of physical,mental and social that leading to improved quality of life. The purpose of this study was to examine to what extent this educational Program could improve low back pain patients' HRQOL.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Back school	Experimental	a kind of educational program for low back pain	Behavioral: back school
back school	Experimental		Behavioral: back school

Interventions

Name	Type	Description	Arm Group Labels	Other Names
back school	Behavioral	A kind of educational program for low back pain	Back school back school

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability		before intervention

Secondary Outcomes

Measure	Description	Time Frame
SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability		3-6-12-18-24-30-36 month after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
age 18-70 years.

Exclusion Criteria:

Osteoporosis
Newly operation on the back up to 2 years before the beginning of the study
Fresh vertebral fracture
Malignancy
Infection in the back
spondylolisthesis
Problem in understanding Farsi Language

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmad Re Jamshidi, MD	Tehran University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tehran University of Medical Sciences		Tehran	Tehran Province		Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24576271	Derived	Tavafian SS, Jamshidi AR, Mohammad K. Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months. Int J Rheum Dis. 2014 Feb;17(2):159-64. doi: 10.1111/1756-185X.12116. Epub 2013 Jun 21.