Condition category
Musculoskeletal Diseases
Date applied
20/06/2006
Date assigned
26/07/2006
Last edited
05/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ali Montazeri

ORCID ID

Contact details

P.O. Box 13185-1488
Tehran
-
Iran
+98 (0) 21 6409786
ali@jdcord.jd.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Low back education programme could improve quality of life in patients with low back pain.

Ethics approval

Ethics approval received from Tehran University of Medical Sciences Ethics Committee in March 2003.

Study design

Randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Low back pain

Intervention

Back School Programme: the back school programme is a four-day, five-session, multidimensional and interdisciplinary educational regime designed to assess each patient’s physical condition, personal characteristics, lifestyle and subsequent ability to cope.
Group 1: patients received medication and education with the back school programme.
Group 2: patients received the medication alone.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The principal outcome measure was quality of life. The mean increase in quality of life score above the baseline was used as the main outcome measure of the patients’ responses to the intervention.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2003

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women age 18 years and over
2. Suffering from chronic back pain (persisting for 90 days or more)
3. Having a telephone number for regular contact with a responsible caregiver

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

102

Participant exclusion criteria

1. Patients who had back surgery two years prior to the initial observation
2. If the complaint was restricted to the sacroiliac joint or the cervical or thoracic regions
3. Patients with congenital spine disease
4. Patients with a low back complaint that had persisted less than 90 days

Recruitment start date

01/07/2003

Recruitment end date

30/09/2003

Locations

Countries of recruitment

Iran

Trial participating centre

P.O. Box 13185-1488
Tehran
-
Iran

Sponsor information

Organisation

Iranian Institute for Health Sciences Research (Iran)

Sponsor details

P.O. Box 13145-1756
Tehran
-
Iran
+98 (0) 21 66480804
info@ihsr.ac.ir

Sponsor type

Research organisation

Website

http://www.ihsr.ac.ir

Funders

Funder type

Research organisation

Funder name

Iranian Institute for Health Sciences Research (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17328809

Publication citations

  1. Results

    Tavafian SS, Jamshidi A, Mohammad K, Montazeri A, Low back pain education and short term quality of life: a randomized trial., BMC Musculoskelet Disord, 2007, 8, 21, doi: 10.1186/1471-2474-8-21.

Additional files

Editorial Notes