Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000392460
Ethics application status
Approved
Date submitted
29/06/2007
Date registered
31/07/2007
Date last updated
31/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physio Therapy before and after of lumbar column´s surgery
Scientific title
Application of a physiotherapeutic treatment protocol before and after of lumbar column's surgery: stories of cases
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical intervention of the lumbar column 2185 0
Condition category
Condition code
Surgery 2280 2280 0 0
Physical Medicine / Rehabilitation 2281 2281 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical evaluation through needle and brush and classified according to ASIA (Sensitivity Absence = 0; Alteration of the sensitivity = 1; Normal Sensitivity = 2)- painful and tactile sensitivity - before and after the physical therapy and the surgical intervention.
Physical Therapy: twice a day, 20 minutes, for 3 days starting one day before surgery.
Physiotherapeutic protocol: Exercises for pulmonary reexpansion and active exercises of the members for maintenance of the muscle force and prevention of blood circulation dysfunction
Intervention code [1] 1861 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3172 0
Improvement in the tactile and painful sensitivity - measure through needle and brush and classified according to ASIA.
Timepoint [1] 3172 0
Monitored one day before surgery and in the second day after surgery intervention.
Secondary outcome [1] 5289 0
Precocious deambulation - absence of muscular weakness in inferior Members during walking.
Timepoint [1] 5289 0
Measured through the questionnaire in the second day after surgery intervention.

Eligibility
Key inclusion criteria
Patient submitted of surgical intervention of the lumbar column.
Minimum age
45 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Another patology with alterations of sensitivity or the motor control.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2447 0
University
Name [1] 2447 0
Universidade Metodista de Piracicaba
Country [1] 2447 0
Brazil
Primary sponsor type
Individual
Name
Giuliana Gasparotto
Address
Country
Secondary sponsor category [1] 2217 0
Individual
Name [1] 2217 0
Raquel Martins
Address [1] 2217 0
Country [1] 2217 0
Secondary sponsor category [2] 2218 0
Individual
Name [2] 2218 0
Luciane M. Fernandes
Address [2] 2218 0
Country [2] 2218 0
Secondary sponsor category [3] 2219 0
Individual
Name [3] 2219 0
Daniela Faleiros Bertelli
Address [3] 2219 0
Country [3] 2219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4301 0
Univeristy Metodista de Piracicaba
Ethics committee address [1] 4301 0
www.unimep.br/cepesquisa
Ethics committee country [1] 4301 0
Brazil
Date submitted for ethics approval [1] 4301 0
Approval date [1] 4301 0
23/06/2006
Ethics approval number [1] 4301 0
Research Protocol No. 11/06

Summary
Brief summary
Aplication of a physioterapeutic treatment protocol to minimize the complication of the permanence in the stream bed and to allow the precocious deambulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27675 0
Address 27675 0
Country 27675 0
Phone 27675 0
Fax 27675 0
Email 27675 0
Contact person for public queries
Name 11050 0
Giuliana Gasparotto
Address 11050 0
Rua Jose Maria Araujo
125 Jardim Boa Vista Santa Bárbara d´Oeste
São Paulo
Country 11050 0
Brazil
Phone 11050 0
+55 19 34635542
Fax 11050 0
Email 11050 0
[email protected]
Contact person for scientific queries
Name 1978 0
Giuliana Gasparotto
Address 1978 0
Rua Jose Maria Araujo
125 Jardim Boa Vista Santa Bárbara d´Oeste
São Paulo
Country 1978 0
Brazil
Phone 1978 0
+55 19 34635542
Fax 1978 0
Email 1978 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.