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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783562
Other study ID # PP001032008
Secondary ID
Status Completed
Phase Phase 1
First received October 30, 2008
Last updated October 30, 2008
Start date October 2007
Est. completion date December 2007

Study information

Verified date October 2008
Source University of Bologna
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

- medical history of serious injury

- spinal surgery

- malignant pathology

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Extension-oriented exercise program
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 Brochure
The brochure showed the correct way to lift loads, and provided ergonomic suggestions to prevent musculoskeletal complaints, according to the Italian legislation

Locations

Country Name City State
Italy University of Bologna Bologna Emilia-Romagna

Sponsors (1)

Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Epub 2007 Sep 25. — View Citation

Brown 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. — View Citation

Grant KA, Habes DJ, Tepper AL. Work activities and musculoskeletal complaints among preschool workers. Appl Ergon. 1995 Dec;26(6):405-10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Roland Morris Disability Questionnaire and Oswestry Disability Index Baseline, 2 months No
Secondary Pain Drawing and Visual Analogue Scale Baseline, 2 months No
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