Low Back PainPhase 3NCT00596076
Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II)
A Phase 3 study testing Back School in people with Low Back Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to Control Rheumatic Diseases). The purpose of this study is to find if Back School training has any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- 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
- 30 participants
- Where
- 1 siteIran
- Study dates
- Feb 2008to Sep 2008
- Phase
- Phase 3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of mechanical low back pain in the last six months
Who cannot join
- History of inflammatory spinal diseases
- Severe scoliosis
- History of spinal surgery
- History of spinal malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Back School on Low Back Pain and Quality of Life of Workers of a Pharmaceutics Company in Tehran Suburb. COPCORD Study (Stage II)
The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to Control Rheumatic Diseases). The purpose of this study is to find if Back School training has any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.
Read the detailed description
A back school will be held on at the Modava Pharmaceutical Factory, in Tehran suburbs. We estimate that this prospective study will include almost one third of the 70 workers in the factory. The study provides objective data and subjective information from patients. The clinical benefits of back school on low back pain and quality of life will be reported at the beginning and the end of intervention and after a period of 6 months follow up.
- Conditions
- Low Back Pain
- Being tested
- Back School
- Keywords
- Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back SchoolBehavioural
All the workers undergo a clinical examination for low back pain, by two trained practitioner. Those workers who are diagnosed for mechanical low back pain during the last six months fulfill a self report Quality of Life Questionnaire (SF36). The objective level of low back pain will obtain by a visual analogue scale. Then a back school training course will be held in 6 sessions, in 6 consecutive weeks. Two previously trained physiotherapists are responsible for the training course. Each series will have 10 participants. They will learn vertebral column anatomy and its function at the first session. The proper posture and exercises to reduce or inhibit low back pain are taught in the next 4 sessions. The 6th session is arranged for answering questions and checking how exercises are performed.
A visual analogue scale and quality of life assessment will be held at the end of the last session and the end of the sixth month.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Workers with low back pain Receives: Behavioral: Back School |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Comparison of quality of life in patients with low back pain before and after Back school training. 2- Comparison of low back pain based on a visual analogue scale before and after back school training.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Fereydoun Davatchi, MD, Study chair, Rheumatology Research Center, Medical Sciences/University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596076
- Sponsor's protocol ID
- 85-04-41-4972
- Status last verified
- Aug 2010
- First submitted
- 5 Jan 2008
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Back School on Low Back Pain and Quality of Life of Workers of a Pharmaceutics Company in Tehran Suburb. COPCORD Study (Stage II)
- ClinicalTrials.gov ID
- NCT00596076
- Acronym / sponsor ID
- 85-04-41-4972
- Conditions
- Low Back Pain
- Keywords
- Low back pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 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 study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to Control Rheumatic Diseases). The purpose of this study is to find if Back School training has any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.
Detailed description
A back school will be held on at the Modava Pharmaceutical Factory, in Tehran suburbs. We estimate that this prospective study will include almost one third of the 70 workers in the factory. The study provides objective data and subjective information from patients. The clinical benefits of back school on low back pain and quality of life will be reported at the beginning and the end of intervention and after a period of 6 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Back SchoolWorkers with low back pain |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- History of mechanical low back pain in the last six months
Key exclusion criteria (4 listed)
- History of inflammatory spinal diseases
- Severe scoliosis
- History of spinal surgery
- History of spinal malignancy
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 SchoolAll the workers undergo a clinical examination for low back pain, by two trained practitioner. Those workers who are diagnosed for mechanical low back pain during the last six months fulfill a self report Quality of Life Questionnaire (SF36). The objective level of low back pain will obtain by a visual analogue scale. Then a back school training course will be held in 6 sessions, in 6 consecutive weeks. Two previously trained physiotherapists are responsible for the training course. Each series will have 10 participants. They will learn vertebral column anatomy and its function at the first session. The proper posture and exercises to reduce or inhibit low back pain are taught in the next 4 sessions. The 6th session is arranged for answering questions and checking how exercises are performed. A visual analogue scale and quality of life assessment will be held at the end of the last session and the end of the sixth month. | Behavioural | 1 |
Primary outcome
1- Comparison of quality of life in patients with low back pain before and after Back school training. 2- Comparison of low back pain based on a visual analogue scale before and after back school training.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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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.
Fereydoun Davatchi, MD study chair
Rheumatology Research Center, Medical Sciences/University of Tehran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Back School in people with 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 16 Aug 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1- Comparison of quality of life in patients with low back pain before and after Back school training. 2- Comparison of low back pain based on a visual analogue scale before and after back school training. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2010.