Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000357459
Ethics application status
Approved
Date submitted
29/06/2007
Date registered
4/07/2007
Date last updated
4/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Neuromuscle electrical stimulation in rehabilitation of knee osteoarthritis patients
Scientific title
A randomised controlled trial comparing the effects of exercises, electrical stimulation and education techniques on rehabilitation of knee osteoarthritis patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis patients 1914 0
Condition category
Condition code
Musculoskeletal 2005 2005 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 2 times a week for 8 weeks, 41 patients per group.
3 groups
interventions groups
Group 1: exercises (bike 10min, isometric quadriceps exercises, stretching)
Group 2: Electrical stimulation (bike 10min, isometric quadriceps exercises plus electrical stimulation, stretching)
Intervention code [1] 1860 0
Rehabilitation
Comparator / control treatment
Control Group
Group 3: Education with some devices of weight reduction, how to reduce the pain with ice or mild hot water, use of comfortable shoes and some informations about the desease.
Control group
Active

Outcomes
Primary outcome [1] 2829 0
Function
Timepoint [1] 2829 0
Assessed pre and immediately post intervention
Primary outcome [2] 2830 0
Timed up and go test
Timepoint [2] 2830 0
Assessed pre and immediately post intervention
Primary outcome [3] 2831 0
Pain
Timepoint [3] 2831 0
Assessed pre and immediately post intervention
Primary outcome [4] 2832 0
Analogic visual scale
Timepoint [4] 2832 0
Assessed pre and immediately post intervention
Secondary outcome [1] 4776 0
Activity of Daily Living Scale(ADL)
Timepoint [1] 4776 0
Assessed pre and immediately post intervention
Secondary outcome [2] 4777 0
Western Ontario and
Timepoint [2] 4777 0
Assessed pre and immediately post intervention
Secondary outcome [3] 4778 0
McMaster Osteoarthritis Index (WOMAC)
Timepoint [3] 4778 0
Assessed pre and immediately post intervention
Secondary outcome [4] 4779 0
Short Form - 36
Timepoint [4] 4779 0
Assessed pre and immediately post intervention

Eligibility
Key inclusion criteria
Knee osteoarthritis (grade 2 ou more in Kelgreen Lawrence classification), knee pain,
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Knee arthroplastie, symptomatic hip osteoarthritis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
the people assessing the outcomes (assessor) and the people analysing the results/data (data analyst) will be blinded
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
123
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2149 0
Hospital
Name [1] 2149 0
Ambulatory of Specialities of Grajau
Country [1] 2149 0
Brazil
Primary sponsor type
Individual
Name
Aline Mizusaki Imoto
Address
Country
Secondary sponsor category [1] 1950 0
Individual
Name [1] 1950 0
Virgínia Fernandes Moça Trevisani
Address [1] 1950 0
Country [1] 1950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3944 0
Federal University of São Paulo
Ethics committee address [1] 3944 0
Ethics committee country [1] 3944 0
Brazil
Date submitted for ethics approval [1] 3944 0
Approval date [1] 3944 0
09/03/2007
Ethics approval number [1] 3944 0
CEP 0141/07

Summary
Brief summary
purpose of the study: verify the effectivity of electrical stimulation and exercises in quadriceps exercise at knee function and pain.
1 - Hypothesis:
the electrical stimulation plus exercises and only the exercises are better than educational program
2 - the group submmited to electrical stimulation is better than the group that did only exercises.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27674 0
Address 27674 0
Country 27674 0
Phone 27674 0
Fax 27674 0
Email 27674 0
Contact person for public queries
Name 11049 0
Aline Mizusaki Imoto
Address 11049 0
Rua Pedro de Toledo 598
Country 11049 0
Brazil
Phone 11049 0
55-11-55752970
Fax 11049 0
Email 11049 0
[email protected]
Contact person for scientific queries
Name 1977 0
Maria Stella Peccin
Address 1977 0
Rua Pedro de Toledo 598
Country 1977 0
Brazil
Phone 1977 0
55-11-55752970
Fax 1977 0
Email 1977 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.