Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000232033
Ethics application status
Approved
Date submitted
17/03/2010
Date registered
19/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of physiotherapy resources in knee osteoarthritis: a randomized controlled trial with therapeutic exercise, ear acupuncture and transcutaneous electrical nerve stimulation.
Scientific title
Effectiveness of physiotherapy resources on pain, quantitative physical functional and self related physical function in women with knee osteoarthritis: a randomized controlled trial with therapeutic exercise, ear acupuncture and transcutaneous electrical nerve stimulation
Secondary ID [1] 1517 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 256983 0
Condition category
Condition code
Musculoskeletal 257133 257133 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One intervention group will receive transcutaneous electrical nerve stimulation (TENS) application before therapeutic exercise. This stimulation will last 40 minutes, and will be carried out 3 times per week, in a total of 4 weeks. Conventional TENS parameters will be used.
The other intervention group will have ear acupuncture sessions before therapeutic exercise. This therapy will be carried out once a week, in a total of 4 weeks, and each session will last 15 minutes. Conventional puncture ear points will be used.
Both intervention groups will have therapeutic exercise after the specific therapy intervention of each group. Therapeutic exercise sessions will last 40 minutes and will be carried out 3 times per week, in a total of 4 weeks.
Intervention code [1] 256158 0
Rehabilitation
Comparator / control treatment
The control group will have usual rehabilitation therapy with therapeutic exercises. Therapeutic exercises include warming, strengthening and stretching. This therapy will last 40 minutes and will be carried out 3 times per week, in a total of 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 258028 0
Pain by Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [1] 258028 0
at pre-intervention, post-intervention and at one month follow up
Primary outcome [2] 258030 0
Self related physical function by Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [2] 258030 0
at pre-intervention, post-intervention and at one month follow up
Secondary outcome [1] 263591 0
Quantitative physical funtion by step test
Timepoint [1] 263591 0
at pre-intervention, post-intervention and at one month follow up

Eligibility
Key inclusion criteria
To participate in the study, subjects should be women with clinical diagnose of knee osteoarthritis according to American College of Rheumatology. Besides they should have felt any pain in their knee for the last 6 months and 14 days previously allocation in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects were excluded if they had history of lower extremity surgery with or not prosthesis, any type of drug abuse, corticoid application in the last 3 months, neurologic disease or another orthopaedic and rheumatic affection.
Besides subjects were excluded if they were unable to attend the number of treatment sessions established by researchers previously, or missed two treatment sessions, sequentially.

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)
Subjects will be recruited from the waiting list for physiotherapy from University Hospital of Federal University of Juiz de Fora.
At first, a blinded physiotherapist evaluated the subject in order to know if it was eligible for inclusion in this study. After this evaluation, the participant will be randomly allocated into intervention and control groups. The allocation procedure will be carried out by a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomly allocated in each treatment group according to the non-stratified randomization. The simple randomization procedure used was dice rolling. Number 1 and 4 was control group. 2 and 5 was ear acupuncture intervention and 3 and 6 was transcutaneous electrical nerve stimulation.
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
Recruiting
Date of first participant enrolment
Anticipated
15/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2545 0
Brazil
State/province [1] 2545 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 256659 0
Self funded/Unfunded
Name [1] 256659 0
Jennifer G. Peixoto
Country [1] 256659 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Juiz de Fora
Address
Centro de Ciencias da Saude
Campus Universitario - Bairro Martelos
Zip Code: 36036-330
Country
Brazil
Secondary sponsor category [1] 255947 0
Hospital
Name [1] 255947 0
Centro de Atencao a Saude da UFJF
Address [1] 255947 0
Centro de Ciencias da Saude
Campus Universitario - Bairro Martelos
Zip Code: 36036-330
Country [1] 255947 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258681 0
The University Institutional research ethics committee approved this study (protocol 439/2007)
Ethics committee address [1] 258681 0
Comite de Etica em Pesquisa com Seres Humanos
Pro-Reitoria de Pesquisa
Campus Universitario s/n
Rua Jose Lourenco Kelmer, s/n - Bairro Sao Pedro - CEP: 36036-330
Ethics committee country [1] 258681 0
Brazil
Date submitted for ethics approval [1] 258681 0
Approval date [1] 258681 0
Ethics approval number [1] 258681 0

Summary
Brief summary
Objective: Evaluate the effect comparatively, between a protocol of individualized therapeutic exercises with ear acupuncture and the transcutaneous electrical nerve stimulation (TENS) with the aim to improve pain and functional performance of volunteers with OA in the knee.
Desing: A single-blinded randomized clinical trial
Subjects: 30 women with knee osteoarthritis (age above 18 years) randomized to intervention group (10 women in each group) and to control group (10 women)
Interventions: Both intervention groups had 12 sessions of therapeutic exercise 3 times per week (4 weeks). One intervention group will be submitted a 12 sessions of TENS application before therapeutic exercise sessions for 40 minutes with conventional parameters. The other intervention group will have four sessions of ear acupuncture once in week before therapeutic exercise.
The control group will maintain usual rehabilitation therapy with therapeutic exercise during the total period of intervention (4 weeks).
Main Measures: Women will be assessed with Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) in pain and self-reported physical function domains before and after intervention, and after one month follow up. The step test was also used as a quantitative physical function measure before and after intervention, and after one month follow up.
Trial website
Trial related presentations / publications
After completing this study, the results will be presented in national and international scientific events and manuscript will be send to publication.
Public notes

Contacts
Principal investigator
Name 30950 0
Address 30950 0
Country 30950 0
Phone 30950 0
Fax 30950 0
Email 30950 0
Contact person for public queries
Name 14197 0
Jennifer G. Peixoto
Address 14197 0
Departamento de Fisioterapia
Centro de Ciencias da Saude
Campus Universitário - Bairro Martelos – Cep: 36036-330
Country 14197 0
Brazil
Phone 14197 0
55 - 32 - 3229-3738
Fax 14197 0
55 - 32 - 3229-3843
Email 14197 0
[email protected]
Contact person for scientific queries
Name 5125 0
Jennifer G. Peixoto
Address 5125 0
Departamento de Fisioterapia
Centro de Ciencias da Saude
Campus Universitario - Bairro Martelos – Cep: 36036-330
Country 5125 0
Brazil
Phone 5125 0
55 - 32 - 3229-3738
Fax 5125 0
55 - 32 - 3229-3843
Email 5125 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

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