NCT00783562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_1 low-back-pain

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

2 months

First QC Date

October 30, 2008

Last Update Submit

October 30, 2008

Conditions

Low Back PainNeck Pain

Keywords

Low back painNeck painFunctional disabilityNursery school teachersExercise programPrevention

Outcome Measures

Primary Outcomes (1)

  • Roland Morris Disability Questionnaire and Oswestry Disability Index

    Baseline, 2 months

Secondary Outcomes (1)

  • Pain Drawing and Visual Analogue Scale

    Baseline, 2 months

Study Arms (2)

1

EXPERIMENTAL
Other: Extension-oriented exercise programOther: Informative Brochure

2

ACTIVE COMPARATOR
Other: Informative Brochure

Interventions

Extension-oriented exercise programOTHER

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)

Also known as: EOTA
1
Informative BrochureOTHER

The brochure showed the correct way to lift loads, and provided ergonomic suggestions to prevent musculoskeletal complaints, according to the Italian legislation

Also known as: Educational, Informative Pamphlet
12

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • medical history of serious injury
  • spinal surgery
  • malignant pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

Related 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. doi: 10.2522/ptj.20060297. Epub 2007 Sep 25.

    PMID: 17895350RESULT

  • Grant 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.

    PMID: 15677041RESULT

  • 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.

    PMID: 8113928RESULT

MeSH Terms

Conditions

Low Back PainNeck Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paolo Pillastrini, MSc

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

IT(1)