Note that ANZCTR staff will not be processing any registration applications on Thursday 8th October and Friday 9th October. We will process as many applications as possible before Thursday, and any remaining submissions will be processed early the following week. Thank you and apologies for any inconvenience this may cause.

Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Neuromuscle electrical stimulation in rehabilitation of knee osteoarthritis patients
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
Universal Trial Number (UTN)
Trial acronym

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

Study type
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 1860 0
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

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

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

Study design
Purpose of the study
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
Other design features
the people assessing the outcomes (assessor) and the people analysing the results/data (data analyst) will be blinded
Phase 1
Type of endpoint(s)

Anticipated date of first participant enrolment
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
Actual sample size
Recruitment status
Closed: follow-up continuing

Funding & Sponsors
Funding source category 2149 0
Name 2149 0
Ambulatory of Specialities of Grajau
Address 2149 0
Country 2149 0
Primary sponsor
Primary sponsor name
Aline Mizusaki Imoto
Primary sponsor address
Primary sponsor country
Secondary sponsor category 1950 0
Name 1950 0
Virgínia Fernandes Moça Trevisani
Address 1950 0
Country 1950 0

Ethics approval
Ethics application status
Ethics committee name 3944 0
Federal University of São Paulo
Ethics committee address 3944 0
Ethics committee country 3944 0
Date submitted for ethics approval 3944 0
Approval date 3944 0
Ethics approval number 3944 0
CEP 0141/07

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

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
Phone 11049 0
Fax 11049 0
Email 11049 0
Contact person for scientific queries
Name 1977 0
Maria Stella Peccin
Address 1977 0
Rua Pedro de Toledo 598
Country 1977 0
Phone 1977 0
Fax 1977 0
Email 1977 0