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Trial registered on ANZCTR


Registration number
ACTRN12609000473268
Ethics application status
Approved
Date submitted
7/10/2008
Date registered
17/06/2009
Date last updated
17/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of muscular stretching following transcutaneous electrical nerve stimulation (TENS) versus usual muscular stretching only on flexibility and pain in healthy people
Scientific title
Effects of muscular stretching and transcutaneous electrical nerve stimulation compared to usual muscular stretching on flexibility of hamstring and pain for healthy people: a randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stretching and TENS on flexibility of hamstring muscles in healthy women, without musculoskeletal disease. 3796 0
Condition category
Condition code
Musculoskeletal 3976 3976 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1, Stretching: static hamstring stretches (3 repetitions of 30 seconds) daily for 2 weeks. Group 2, Stretching + TENS: 10 minutes TENS (100Hz, 40 micros), immediately followed by static hamstring stretches (3 repetitions of 30 seconds) daily for 2 weeks. The TENS was connected to the participant by self-adhesive electrodes. During the Stretching the TENS remains switched on.
Intervention code [1] 3517 0
Rehabilitation
Comparator / control treatment
Group 3, Control: no treatment given for a period of 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 4879 0
range of motion using a digital goniometer
Timepoint [1] 4879 0
baseline and at 4 weeks after commencement of treatment.
Secondary outcome [1] 8236 0
pain using the visual analogic scale (VAS)
Timepoint [1] 8236 0
baseline and at 4 weeks after commencement of treatment.

Eligibility
Key inclusion criteria
healthy people, without musculoskeletal disease.
Minimum age
18 Years
Maximum age
25 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluded from the study if they are unable to tolerate the stretching.

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)
the subjects were allocated by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
subjects were randomly assigned to 3 groups. One control group and two stretching groups (stretching and stretching + TENS). we select the pateints randomly by using randomisation tablesite. we used a simple randomisation by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
no other design features.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1249 0
Brazil
State/province [1] 1249 0
rio grande do norte

Funding & Sponsors
Funding source category [1] 3981 0
University
Name [1] 3981 0
universidade federal do rio grande do norte
Address [1] 3981 0
avenida salgado filho (br 101), lagoa nova, campus central, natal-rn-brasil, CEP 59078970
Country [1] 3981 0
Brazil
Primary sponsor type
University
Name
departamento de fisioterapia
Address
universidade federal do rio grande do norte, avenida salgado filho (br 101), lagoa nova, natal-rn-brasil, CEP 59078970
Country
Brazil
Secondary sponsor category [1] 3570 0
Individual
Name [1] 3570 0
ricardo oliveira guerra
Address [1] 3570 0
avenida salgado filho (br 101), lagoa nova, CEP 59078970
Country [1] 3570 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6055 0
hospital universitario onofre lopes
Ethics committee address [1] 6055 0
universidade federal do rio grande do norte, avenida salgado filho (br 101), lagoa nova, natal-rn-brasil, CEP 59078970
Ethics committee country [1] 6055 0
Brazil
Date submitted for ethics approval [1] 6055 0
01/07/2007
Approval date [1] 6055 0
01/08/2007
Ethics approval number [1] 6055 0
1/06/0037

Summary
Brief summary
The increase of the stretching pain tolerance is an important factor for flexibility gain. Transcutaneous Electrical Nerve Stimulation (TENS) is an important therapy for pain treatment, however its use during stretching was not investigated. To evaluate stretching and TENS association effect in hamstrings muscles of healthy women about flexibility gain
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29010 0
Address 29010 0
Country 29010 0
Phone 29010 0
Fax 29010 0
Email 29010 0
Contact person for public queries
Name 12167 0
alvaro campos cavalcanti maciel
Address 12167 0
rua moises gosson, 1442, natal-rn. CEP: 59056-060
Country 12167 0
Brazil
Phone 12167 0
+55 84 91296796
Fax 12167 0
Email 12167 0
alvarohuab@ufrnet.br
Contact person for scientific queries
Name 3095 0
alvaro campos cavalcanti maciel
Address 3095 0
rua moises gosson, 1442, Natal-RN. CEP: 59056-060
Country 3095 0
Brazil
Phone 3095 0
+55 84 91296796
Fax 3095 0
Email 3095 0
alvarohuab@ufrnet.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary