NCT00600197

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 13, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

1.8 years

First QC Date

January 13, 2008

Last Update Submit

November 17, 2009

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability

    before intervention

Secondary Outcomes (1)

  • SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability

    3-6-12-18-24-30-36 month after intervention

Study Arms (2)

Back school

EXPERIMENTAL

a kind of educational program for low back pain

Behavioral: back school

back school

EXPERIMENTAL
Behavioral: back school

Interventions

back schoolBEHAVIORAL

A kind of educational program for low back pain

Back schoolback school

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • 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.

    PMID: 24576271DERIVED

Study Officials

  • Ahmad Re Jamshidi, MD

    Tehran University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2008

First Posted

January 24, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

September 1, 2012

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

IR(1)