Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
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
Query!
Condition category
Condition code
Musculoskeletal
3976
3976
0
0
Query!
Normal musculoskeletal and cartilage development and function
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
3517
0
Rehabilitation
Query!
Comparator / control treatment
Group 3, Control: no treatment given for a period of 2 weeks.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
4879
0
range of motion using a digital goniometer
Query!
Assessment method [1]
4879
0
Query!
Timepoint [1]
4879
0
baseline and at 4 weeks after commencement of treatment.
Query!
Secondary outcome [1]
8236
0
pain using the visual analogic scale (VAS)
Query!
Assessment method [1]
8236
0
Query!
Timepoint [1]
8236
0
baseline and at 4 weeks after commencement of treatment.
Query!
Eligibility
Key inclusion criteria
healthy people, without musculoskeletal disease.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
25
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Subjects will be excluded from the study if they are unable to tolerate the stretching.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the subjects were allocated by sealed opaque envelopes
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
no other design features.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/10/2008
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
1249
0
Brazil
Query!
State/province [1]
1249
0
rio grande do norte
Query!
Funding & Sponsors
Funding source category [1]
3981
0
University
Query!
Name [1]
3981
0
universidade federal do rio grande do norte
Query!
Address [1]
3981
0
avenida salgado filho (br 101), lagoa nova, campus central, natal-rn-brasil, CEP 59078970
Query!
Country [1]
3981
0
Brazil
Query!
Primary sponsor type
University
Query!
Name
departamento de fisioterapia
Query!
Address
universidade federal do rio grande do norte, avenida salgado filho (br 101), lagoa nova, natal-rn-brasil, CEP 59078970
Query!
Country
Brazil
Query!
Secondary sponsor category [1]
3570
0
Individual
Query!
Name [1]
3570
0
ricardo oliveira guerra
Query!
Address [1]
3570
0
avenida salgado filho (br 101), lagoa nova, CEP 59078970
Query!
Country [1]
3570
0
Brazil
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
6055
0
hospital universitario onofre lopes
Query!
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
Query!
Ethics committee country [1]
6055
0
Brazil
Query!
Date submitted for ethics approval [1]
6055
0
01/07/2007
Query!
Approval date [1]
6055
0
01/08/2007
Query!
Ethics approval number [1]
6055
0
1/06/0037
Query!
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
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
29010
0
Query!
Address
29010
0
Query!
Country
29010
0
Query!
Phone
29010
0
Query!
Fax
29010
0
Query!
Email
29010
0
Query!
Contact person for public queries
Name
12167
0
alvaro campos cavalcanti maciel
Query!
Address
12167
0
rua moises gosson, 1442, natal-rn. CEP: 59056-060
Query!
Country
12167
0
Brazil
Query!
Phone
12167
0
+55 84 91296796
Query!
Fax
12167
0
Query!
Email
12167
0
[email protected]
Query!
Contact person for scientific queries
Name
3095
0
alvaro campos cavalcanti maciel
Query!
Address
3095
0
rua moises gosson, 1442, Natal-RN. CEP: 59056-060
Query!
Country
3095
0
Brazil
Query!
Phone
3095
0
+55 84 91296796
Query!
Fax
3095
0
Query!
Email
3095
0
[email protected]
Query!
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.
Download to PDF