Low Back PainPhase 1NCT00783562
Preventive Intervention in Nursery School Teachers
A Phase 1 study testing Extension-oriented exercise program and Informative Brochure in people with Low Back Pain and Neck Pain, run by University of Bologna at 1 site in Italy.
Trial summary
Childcare in nursery schools has been shown to be associated with an elevated prevalence of neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem to be the only effective preventive intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Low Back Pain, Neck Pain
- What is being tested?
- Extension-oriented exercise program and Informative Brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Dec 2007
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population was composed by all the 71 nursery school teachers, employed at the town hall of Forlì, that worked in nine different school buildings similar in size and furniture. As provided for by the Italian law (Emilia-Romagna Regional Law No. 1 of January 10, 2000 - art. 32, followed by the Directive of July 25, 2001), teachers had the same working schedule and the same workload in terms of teacher/children ratio depending on children age.
Who cannot join
- medical history of serious injury
- spinal surgery
- malignant pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Extension-Oriented Exercise Program in Preventing Neck and Low Back Complaints in Nursery School Teachers
Childcare in nursery schools has been shown to be associated with an elevated prevalence of neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem to be the only effective preventive intervention. Thus the purpose of this study is to determine the effectiveness of an extension-oriented exercise program in preventing low back/neck pain and functional disability in nursery school teachers. In addition, the investigators also sought to identify the occurrence of musculoskeletal complaints in this category of workers.
Read the detailed description
Seventy-one nursery school teachers working in nine school buildings were randomly divided into two groups, with each school as a unit of randomization. All the teachers in both groups received an ergonomic brochure; teachers in the experimental group also received an extension-oriented exercise program, conducted by a physical therapist. Data were collected at baseline and at a two-month follow-up. The primary outcome measure recorded was the level of disability (Roland Morris Disability Questionnaire and Oswestry Disability Index), while secondary outcome measures included LBP and neck pain presence (Pain Drawing) and intensity (Visual Analogue Scale). At follow-up, a significant improvement was registered in the experimental group for all the outcomes evaluated. In conclusion a six-session extension-oriented exercise program proved decisive in preventing low back and neck complaints and in reducing consequent LBP functional disability among nursery school teachers.
- Conditions
- Low Back Pain, Neck Pain
- Being tested
- Extension-oriented exercise program, Informative Brochure
- Keywords
- Low back pain, Neck pain, Functional disability, Nursery school teachers, Exercise program, Prevention
- Medical subject headings
- Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extension-oriented exercise programOther
Also called EOTA
The exercise program was composed of six graded sessions, two per week for three consecutive weeks. Sessions, each of one hour length, were conducted after the working hours in a wide room of the nursery school, gathering together all the teachers from each school. The exercises were selected in order to reinforce lumbar extension and to strengthen the primary stabilizers of the spine (transversus abdominis, oblique abdominal, multifidus, quadratus lumborum and erector spinae muscles)
Informative BrochureOther
Also called Educational, Informative Pamphlet
The brochure showed the correct way to lift loads, and provided ergonomic suggestions to prevent musculoskeletal complaints, according to the Italian legislation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Extension-oriented exercise program; Other: Informative Brochure |
| 2 | Active comparator | Not described Receives: Other: Informative Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire and Oswestry Disability Index
Measured: Baseline, 2 months
Secondary outcomes (1)
Pain Drawing and Visual Analogue Scale
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Pillastrini, MSc, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783562
- Sponsor's protocol ID
- PP001032008
- Status last verified
- Oct 2008
- First submitted
- 30 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Browder DA, Childs JD, Cleland JA, Fritz JM. Effectiveness of an extension-oriented treatment approach in a subgroup of subjects with low back pain: a randomized clinical trial. Phys Ther. 2007 Dec;87(12):1608-18; discussion 1577-9. doi: 10.2522/ptj.20060297. Epub 2007 Sep 25.
PubMed 17895350Grant KA, Habes DJ, Tepper AL. Work activities and musculoskeletal complaints among preschool workers. Appl Ergon. 1995 Dec;26(6):405-10. doi: 10.1016/0003-6870(95)00057-7.
PubMed 15677041Brown MZ, Gerberich SG. Disabling injuries to childcare workers in Minnesota, 1985 to 1990. An analysis of potential risk factors. J Occup Med. 1993 Dec;35(12):1236-43.
PubMed 8113928
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Extension-Oriented Exercise Program in Preventing Neck and Low Back Complaints in Nursery School Teachers
- ClinicalTrials.gov ID
- NCT00783562
- Acronym / sponsor ID
- PP001032008
- Conditions
- Low Back Pain, Neck Pain
- Keywords
- Low back pain, Neck pain, Functional disability, Nursery school teachers, Exercise program, Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 Oct 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.
Childcare in nursery schools has been shown to be associated with an elevated prevalence of neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem to be the only effective preventive intervention. Thus the purpose of this study is to determine the effectiveness of an extension-oriented exercise program in preventing low back/neck pain and functional disability in nursery school teachers. In addition, the investigators also sought to identify the occurrence of musculoskeletal complaints in this category of workers.
Detailed description
Seventy-one nursery school teachers working in nine school buildings were randomly divided into two groups, with each school as a unit of randomization. All the teachers in both groups received an ergonomic brochure; teachers in the experimental group also received an extension-oriented exercise program, conducted by a physical therapist. Data were collected at baseline and at a two-month follow-up. The primary outcome measure recorded was the level of disability (Roland Morris Disability Questionnaire and Oswestry Disability Index), while secondary outcome measures included LBP and neck pain presence (Pain Drawing) and intensity (Visual Analogue Scale). At follow-up, a significant improvement was registered in the experimental group for all the outcomes evaluated. In conclusion a six-session extension-oriented exercise program proved decisive in preventing low back and neck complaints and in reducing consequent LBP functional disability among nursery school teachers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Extension-oriented exercise program, Other: Informative Brochure |
| 2 | Active comparator | Other: Informative Brochure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population was composed by all the 71 nursery school teachers, employed at the town hall of Forlì, that worked in nine different school buildings similar in size and furniture. As provided for by the Italian law (Emilia-Romagna Regional Law No. 1 of January 10, 2000 - art. 32, followed by the Directive of July 25, 2001), teachers had the same working schedule and the same workload in terms of teacher/children ratio depending on children age.
Key exclusion criteria (3 listed)
- medical history of serious injury
- spinal surgery
- malignant pathology
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 |
|---|---|---|
| Extension-oriented exercise programAlso: EOTAThe exercise program was composed of six graded sessions, two per week for three consecutive weeks. Sessions, each of one hour length, were conducted after the working hours in a wide room of the nursery school, gathering together all the teachers from each school. The exercises were selected in order to reinforce lumbar extension and to strengthen the primary stabilizers of the spine (transversus abdominis, oblique abdominal, multifidus, quadratus lumborum and erector spinae muscles) | Other | 1 |
| Informative BrochureAlso: Educational, Informative PamphletThe brochure showed the correct way to lift loads, and provided ergonomic suggestions to prevent musculoskeletal complaints, according to the Italian legislation | Other | 1, 2 |
Primary outcome
Roland Morris Disability Questionnaire and Oswestry Disability Index
Time frame: Baseline, 2 months
1 secondary outcome
Pain Drawing and Visual Analogue Scale
Time frame: Baseline, 2 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 31 Oct 2008.
- Results publication: PubMed 17895350Browder DA, Childs JD, Cleland JA, Fritz JM. Effectiveness of an extension-oriented treatment approach in a subgroup of subjects with low back pain: a randomized clinical trial. Phys Ther. 2007 Dec;87(12):1608-18; discussion 1577-9. doi: 10.2522/ptj.20060297. Epub 2007 Sep 25.
- Results publication: PubMed 15677041Grant KA, Habes DJ, Tepper AL. Work activities and musculoskeletal complaints among preschool workers. Appl Ergon. 1995 Dec;26(6):405-10. doi: 10.1016/0003-6870(95)00057-7.
- Results publication: PubMed 8113928Brown MZ, Gerberich SG. Disabling injuries to childcare workers in Minnesota, 1985 to 1990. An analysis of potential risk factors. J Occup Med. 1993 Dec;35(12):1236-43.
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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.
Paolo Pillastrini, MSc principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extension-oriented exercise program and Informative Brochure in people with Low Back Pain and Neck Pain, run by University of Bologna at 1 site in Italy.
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 3 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 31 Oct 2008. 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 Italy. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Roland Morris Disability Questionnaire and Oswestry Disability Index (time frame: Baseline, 2 months). 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 NCT00783562, which also lists 3 linked publications.
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 31 Oct 2008.