Chronic Low Back PainNCT00600197
Biopsychosocial Education and Chronic Low Back Pain
A study testing back school in people with Chronic Low Back Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- back school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteIran
- Study dates
- Jul 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
- age 18-70 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- back school
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
back schoolBehavioural
A kind of educational program for low back pain
| Study group | Role | What they receive |
|---|---|---|
| Back school | Experimental | a kind of educational program for low back pain Receives: Behavioral: back school |
| back school | Experimental | Not described Receives: Behavioral: back school |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability
Measured: before intervention
Secondary outcomes (1)
SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability
Measured: 3-6-12-18-24-30-36 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2010 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ahmad Re Jamshidi, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600197
- Sponsor's protocol ID
- 86-03-41-5465
- Status last verified
- Nov 2009
- First submitted
- 13 Jan 2008
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24576271
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00600197
- Acronym / sponsor ID
- 86-03-41-5465
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back school | Experimental | Behavioral: back schoola kind of educational program for low back pain |
| back school | Experimental | Behavioral: back school |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
- age 18-70 years.
Key exclusion criteria (7 listed)
- Osteoporosis
- Newly operation on the back up to 2 years before the beginning of the study
- Fresh vertebral fracture
- Malignancy
- Infection in the back
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| back schoolA kind of educational program for low back pain | Behavioural | Back school, back school |
Primary outcome
SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability
Time frame: before intervention
1 secondary outcome
SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability
Time frame: 3-6-12-18-24-30-36 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
- Derived from this study: PubMed 24576271Tavafian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Re Jamshidi, MD study chair
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing back school in people with Chronic Low Back Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (time frame: before intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2009.