Trial from ANZCTR


Trial ID ACTRN12607000357459
Trial Status: Registered
Date Submitted: 29/06/2007
Date Registered: 4/07/2007
Retrospectively registered

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Public title Effectiveness of Neuromuscle electrical stimulation in rehabilitation of knee osteoarthritis patients
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised controlled trial comparing the effects of exercises, electrical stimulation and education techniques on rehabilitation of knee osteoarthritis patients
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Knee osteoarthritis patients 1914 0
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Condition category: Condition code:
Musculoskeletal Osteoarthritis
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2005 2005 0 0

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Descriptions 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)
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Intervention Code:
Rehabilitation 1860 0
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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.
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Control group Active
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Primary Outcome: Function 2829 0
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Timepoint: Assessed pre and immediately post intervention 2829 0
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Primary Outcome: Timed up and go test 2830 0
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Timepoint: Assessed pre and immediately post intervention 2830 0
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Primary Outcome: Pain 2831 0
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Timepoint: Assessed pre and immediately post intervention 2831 0
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Primary Outcome: Analogic visual scale 2832 0
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Timepoint: Assessed pre and immediately post intervention 2832 0
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Secondary Outcome: Activity of Daily Living Scale(ADL) 4776 0
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Timepoint: Assessed pre and immediately post intervention 4776 0
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Secondary Outcome: Western Ontario and 4777 0
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Timepoint: Assessed pre and immediately post intervention 4777 0
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Secondary Outcome: McMaster Osteoarthritis Index (WOMAC) 4778 0
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Timepoint: Assessed pre and immediately post intervention 4778 0
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Secondary Outcome: Short Form - 36 4779 0
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Timepoint: Assessed pre and immediately post intervention 4779 0
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Key inclusion criteria Knee osteoarthritis (grade 2 ou more in Kelgreen Lawrence classification), knee pain,
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Minimum age 50 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Knee arthroplastie, symptomatic hip osteoarthritis
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) sealed opaque envelopes
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computerised sequence generation
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features the people assessing the outcomes (assessor) and the people analysing the results/data (data analyst) will be blinded
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 1
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Anticipated date of first participant enrolment 1/04/2007
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 123
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Hospital 2149 0
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Name: Ambulatory of Specialities of Grajau 2149 0
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Address: 2149 0
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Country: Brazil 2149 0
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Primary Sponsor Individual
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Name: Aline Mizusaki Imoto
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Secondary Sponsor: Individual 1950 0
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Name: Virgínia Fernandes Moça Trevisani 1950 0
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Address: 1950 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Federal University of São Paulo 3944 0
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Address: 3944 0
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Country: Brazil 3944 0
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Approval Date: 09/03/2007 3944 0
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Submitted Date: 3944 0
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HREC: CEP 0141/07 3944 0
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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.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Aline Mizusaki Imoto
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Address: Rua Pedro de Toledo 598
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Country: Brazil
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Tel: 55-11-55752970
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Email: aline.mizusaki@globo.com
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Contact person for scientific queries
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Name: Maria Stella Peccin
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Address: Rua Pedro de Toledo 598
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Tel: 55-11-55752970
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Email: stella@webtvinterativa.com
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