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Trial registered on ANZCTR


Registration number
ACTRN12609000922279
Ethics application status
Approved
Date submitted
22/10/2009
Date registered
27/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of plantar pressure and of osteomuscular symptoms by means the use of customized and prefabricated arch supports in the work environment
Scientific title
The effect of customised and prefabricated arch supports on plantar pressure and osteomuscular symptoms in female assembly line workers
Secondary ID [1] 1120 0
none
Universal Trial Number (UTN)
U1111-1112-2063
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteomuscular symptoms 252047 0
Condition category
Condition code
Musculoskeletal 252237 252237 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 252238 252238 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ethylvinylacetate arch supports that were individually customized for participants allocated to this intervention, during eight weeks at work (5 days per week for approximately 8 hours per day)
Intervention code [1] 241445 0
Other interventions
Comparator / control treatment
pre-fabricated arch supports during work days (5 days per week for approximately 8 hours per day) for a total duration of 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 253111 0
The Nordic Musculoskeletal Questionnaire was administered and plantar pressure was determined using a computerized baropodometric system (FootWork). Plantar pressure values were obtained using an electronic plantar pressure plate (FootWork, AM3-IST, France), connected to a microcomputer (Pentium III). The system has 2704 active surface sensors, with a frequency of 150 Hz
Timepoint [1] 253111 0
before intervention, 4 weeks and 8 weeks following randomisation.
Secondary outcome [1] 257982 0
nil
Timepoint [1] 257982 0
nil

Eligibility
Key inclusion criteria
women remain standing throughout their daily work shift, wearing the same shoes and cutting leather for the confection of dog chew bones, with signs and symptoms of work-related musculoskeletal conditions in the lumbar region or lower limbs developed while performing the current bone-confection job were included in the study.
Minimum age
18 Years
Maximum age
37 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
were excluded for symptoms the onset of which occurred prior their work activities at the firm, systemic diseases, structural deformity or previous trauma

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2291 0
Brazil
State/province [1] 2291 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 243915 0
Other
Name [1] 243915 0
To the Brazilian agency Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior for financial support, based on the Postgraduate Social Demand Program in Health Sciences of the Faculdade de Medicina de Sao Jose do Rio Preto.
Address [1] 243915 0
Av. Brigadeiro Faria Lima, 5416 - Vila Sao Pedro - 15090-000
Sao Jose do Rio Preto - SP
Country [1] 243915 0
Brazil
Primary sponsor type
Individual
Name
Josiane Schadeck de Almeida
Address
Rua 22, 2111 – Centro, Jales, SP, Brazil CEP: 15700-000
Country
Brazil
Secondary sponsor category [1] 251264 0
Individual
Name [1] 251264 0
Guaracy Carvalho Filho
Address [1] 251264 0
Av. Brigadeiro Faria Lima, 5416 - Vila Sao Pedro - 15090-000
Sao Jose do Rio Preto - SP
Department of Orthopedics and Traumatology
Country [1] 251264 0
Brazil
Secondary sponsor category [2] 251265 0
Individual
Name [2] 251265 0
Carlos Marcelo Pastre
Address [2] 251265 0
Physiotherapy Department, Faculdade de Ciencias e Tecnologia, Universidade Estadual Paulista, Rua Roberto Simonsen, 305. CEP:19060-900, Presidente Prudente, SP
Country [2] 251265 0
Brazil
Secondary sponsor category [3] 251266 0
Individual
Name [3] 251266 0
Carlos Roberto Padovani
Address [3] 251266 0
Departament of Biostatistics, Instituto de Biociencias, Universidade Estadual Paulista,
18618970 Botucatu - SP
Distrito de Rubiao Junior
Country [3] 251266 0
Brazil
Secondary sponsor category [4] 251267 0
Individual
Name [4] 251267 0
Rodrigo Alberto Mendes Dispato Martins
Address [4] 251267 0
Av. Brigadeiro Faria Lima, 5416 - Vila Sao Pedro - 15090-000
Sao Jose do Rio Preto - SP
Country [4] 251267 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244029 0
Research Ethics Committee of Faculdade de Medicina de Sao Jose do Rio Preto
Ethics committee address [1] 244029 0
CEP - Comite de Etica em Pesquisa
Av. Brigadeiro Faria Lima, 5416 Bairro: Sao Pedro
Sao Jose do Rio Preto -SP
CEP: 15090-000
Ethics committee country [1] 244029 0
Brazil
Date submitted for ethics approval [1] 244029 0
10/08/2005
Approval date [1] 244029 0
07/11/2005
Ethics approval number [1] 244029 0
6032/2005

Summary
Brief summary
OBJECTIVE: Compare the effect of the use of two types of arch supports (customized and prefabricated) on the behavior of plantar weight load and osteomuscular symptoms in assembly line workers. METHODS: A randomized trial was carried out with 27 female workers who worked in an orthostatic position, with a mean age of 30.3 ± 7.09 years and weight of 64.85 ± 13.65 Kg, and had osteomuscular symptoms. The Nordic Musculoskeletal Questionnaire was administered and plantar pressure was determined using a computerized baropodometric system (FootWork). The sample was then divided into control group, which wore pre-fabricated arch supports, and intervention group, with wore ethylvinylacetate arch supports during eight weeks. Baropodometric data were collected and the questionnaire was administered again.RESULTS: There was no statistically significant difference in the comparison between groups and baropodometric data. However, a change was noted in the behavior of the load variables between evaluations, with an increase in mean load pressure and maximal plantar pressure (p<0.05). No statistically significant difference was found between groups for any anatomical site in the different evaluations. Within each group, there was a reduction in foot pain and back pain between evaluations (p<0.05). CONCLUSION: Both types of arch support reduced pain symptoms in the lumbar region and feet. After eight weeks of use, there was an increase in maximal and mean plantar pressure and a reduction in plantar surface area with both types of arch support.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30410 0
Address 30410 0
Country 30410 0
Phone 30410 0
Fax 30410 0
Email 30410 0
Contact person for public queries
Name 13657 0
Josiane Schadeck de Almeida
Address 13657 0
Av, João Amadeu, 2160 Centro, Jales, SP, Brazil CEP: 15700-000
Country 13657 0
Brazil
Phone 13657 0
+55 1736323010
Fax 13657 0
+55 1736323010
Email 13657 0
jsalmeidaf@gmail.com
Contact person for scientific queries
Name 4585 0
Josiane Schadeck de Almeida
Address 4585 0
Av, João Amadeu, 2160 Centro, Jales, SP, Brazil CEP: 15700-000
Country 4585 0
Brazil
Phone 4585 0
+55 1736323010
Fax 4585 0
Email 4585 0
jsalmeidaf@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary