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Trial registered on ANZCTR


Registration number
ACTRN12610000302055
Ethics application status
Approved
Date submitted
5/04/2010
Date registered
15/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate effects of transcutaneous electrical nerve stimulation and cryotherapy on the spasticity of hemiparetic subjects
Scientific title
Transcutaneus electrical nerve stimulation reduces spasticity and cryotherapy may increase hyperreflexia in hemiparetic spastic patients
Secondary ID [1] 1582 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spasticity 257108 0
Condition category
Condition code
Neurological 257239 257239 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of Transcutaneous Electrical Nerve Stimulation (TENS) in the conventional manner (100Hertz and 60 microseconds) and cryotherapy in the form of ice compress over the soleus muscle. Both Transcutaneous Electrical Nerve Stimulation and cryotherapy were used for 30 minutes in single session. All the subjects underwent three days of assessment after the following procedures were randomly applied: TENS, cryotherapy or control. The application interval among the resources was of at least 24 hours
Intervention code [1] 256253 0
Rehabilitation
Comparator / control treatment
In the affected limb, the recording of H-reflex, M response of the soleus muscle and electromyogram (EMG) of the tibialis anterior muscle occurred before and after the application of TENS and cryotherapy on different days. In the control, there was not treatment and the evaluation happened in two moments, before and after 30minutes, in a single day in agreement with the randomization. The non-affected limb was evaluated once for comparison with the affected limb.
Control group
Active

Outcomes
Primary outcome [1] 258136 0
There was a reduction in the Hmax/Mmax ratio (P=0.0006) registered by the electromyography (EMG).
Timepoint [1] 258136 0
30 minutes following Transcutaneous Electrical Nerve Stimulation (TENS) application.
Primary outcome [2] 258208 0
There was an increase in the Hmax/Mmax ratio (P=0.0007) and an increase in the latency (P=0.0001) registered by the electromyography (EMG).
Timepoint [2] 258208 0
30 minutes after ice application.
Primary outcome [3] 258209 0
EMG amplitude was not significantly altered.
Timepoint [3] 258209 0
30 minutes following Transcutaneous Electrical Nerve Stimulation and ice application.
Secondary outcome [1] 263780 0
The Hmax/Mmax, H-reflex latency and EMG amplitude of the muscle antagonist of the spastic muscle was not significantly altered
Timepoint [1] 263780 0
30 minutes after control.
Secondary outcome [2] 263821 0
The Hmax/Mmax registered by the electromyography (EMG) was significantly higher in the affected limb (P=0.0245).
Timepoint [2] 263821 0
Non-affected limb compared to the affected limb before any aplication.
Secondary outcome [3] 263823 0
H-reflex latency registered by the electromyography (EMG) was significantly lower in the affected limb (P=0.0375).
Timepoint [3] 263823 0
Non-affected limb compared to the affected limb before any aplication.
Secondary outcome [4] 263825 0
The Electromyogram amplitude of the muscle antagonist of the spastic muscle was decreased in the compromised limb (P< 0.0001).
Timepoint [4] 263825 0
Non-affected limb compared to the affected limb before any aplication.
Secondary outcome [5] 263826 0
Statistically significant differences were found when the Hmax/Mmax ratio (P<0.0001) and H reflex latency (P<0.0001) registered by the electromyography (EMG) were compared between post-TENS, post-cryotherapy and control.
Timepoint [5] 263826 0
When post-TENS, post-cryotherapy and control were compared.

Eligibility
Key inclusion criteria
Clinical diagnosis of Cerebrovascular accident (CVA), minimum lesion duration of 6 months, degree of spasticity between 1 and 3 on the modified Ashworth scale, capacity to obey simple verbal commands and absence of degenerative diseases or orthopedic-traumatic lesions in ankle articulation.
Minimum age
30 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypersensitivity to ice or to electric current, inability to withstand the intensity of the electric current used to record H-reflex and M response and non-attendance at the three assessment days were established as exclusion criteria.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
The subjects underwent three days of assessment after the following procedures were randomly applied: TENS, cryotherapy or control. In the affected limb, the recording of H-reflex, M response of the soleus muscle and EMG of the tibialis anterior muscle occurred before and after the application of TENS and cryotherapy on different days. In the control the assessment was conducted 30 minutes before and 30 minutes after. The non-affected limb was evaluated once for comparison with the affected limb.
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] 2565 0
Brazil
State/province [1] 2565 0
Rio Grande do Norte/Natal

Funding & Sponsors
Funding source category [1] 256753 0
Government body
Name [1] 256753 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico
Address [1] 256753 0
SEPN 507, Bloco B - Ed. Sede do CNPq, Brasilia - Distrito Federal -CEP 70740-901
Country [1] 256753 0
Brazil
Funding source category [2] 256756 0
Government body
Name [2] 256756 0
Fundacao de Apoio a Pesquisa do Estado do Rio Grande do Norte
Address [2] 256756 0
BR 101, Km 94, Centro admnistrativo s/n, Lagoa Nova, Natal - Rio Grande do Norte
CEP: 59064-901
Country [2] 256756 0
Brazil
Primary sponsor type
University
Name
Federal University of Rio Grande do Norte
Address
Av. Senador Salgado Filho, 3000
Caixa Postal 1524 - CEP:59072-970
Natal - Rio Grande do Norte
Country
Brazil
Secondary sponsor category [1] 256034 0
None
Name [1] 256034 0
Address [1] 256034 0
Country [1] 256034 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258768 0
Research Ethics Committee of the Federal University of Rio Grande do Norte
Ethics committee address [1] 258768 0
Av. Senador Salgado Filho, 3000
Caixa Postal 1524,
Natal - Rio Grande do Norte -CEP:59072-970
Ethics committee country [1] 258768 0
Brazil
Date submitted for ethics approval [1] 258768 0
10/04/2009
Approval date [1] 258768 0
09/06/2009
Ethics approval number [1] 258768 0
109/2009

Summary
Brief summary
Objectives. Investigate the hyperreflexia of patients with cerebrovascular accident (CVA) and identify the immediate effects of transcutaneous electrical nerve stimulation (TENS) and cryotherapy on the spasticity and electromyographic activity of hemiparetic subjects.
Design: Nonrandomized Controlled Trial:
Setting: The experiment were conducted in the Laboratory of Analysis of the Human Movement of Physiology Laboratory of the Federal University of Rio Grande do Norte.
Subjects: 16 subjects with CVA-related sequel
Intervention: application of TENS in the conventional manner (100Hz and 60µs) and cryotherapy in the form of ice compress over the soleus muscle
Assessment measurements: H-reflex, M response, Hmax/Max, H-reflex latency and RMS value of surface EMG.
Results: The Hmax/Mmax was significantly higher in the affected limb (P=0.0245). H-reflex latency was significantly lower in the affected limb (P=0.0375). The EMG amplitude of the muscle antagonist of the spastic muscle was decreased in the compromised limb (P< 0.0001). After TENS there was a reduction in the Hmax/Mmax ratio (P=0.0006) and therefore in hyperreflexia. However, soon after ice application there was an increase in the Hmax/Mmax ratio (P=0.0007) and an increase in the latency (P=0.0001). EMG amplitude was not significantly altered by any of the resources. Statistically significant differences were found when the Hmax/Mmax ratio (P<0.0001) and H reflex latency (P<0.0001) were compared between post-TENS, post-cryotherapy and control.
Conclusion: We conclude that TENS can be used for the immediate reduction of spasticity and that cryotherapy may increase hyperreflexia in spastic patients. However, the decrease or increase in spasticity after intervention did not alter electromyographic activity in the antagonist of the spastic muscle.
Trial website
No website provided
Trial related presentations / publications
Not published yet. Submitted to Archives of Medicine and Physical Rehabilitation
Public notes

Contacts
Principal investigator
Name 31009 0
Address 31009 0
Country 31009 0
Phone 31009 0
Fax 31009 0
Email 31009 0
Contact person for public queries
Name 14256 0
Ana Raquel Rodrigues Lindquist
Address 14256 0
Universidade Federal do Rio Grande do Norte - UFRN
Departamento de Fisioterapia
Centro de Ciencias da Saude
Av. Senador Salgado Filho, 3000, Natal-RN
Caixa Postal 1524 - CEP:59072-970
Country 14256 0
Brazil
Phone 14256 0
55 84 3342 2010
Fax 14256 0
55 84 3342 2000
Email 14256 0
raquellindquist@gmail.com
Contact person for scientific queries
Name 5184 0
Fabio de Lima Martins
Address 5184 0
R. Eunice de Sa Ramalho, 86, Bancarios
Joao Pessoa - PB
CEP: 58062-000
Country 5184 0
Brazil
Phone 5184 0
55 83 91345162
Fax 5184 0
Email 5184 0
fabtins@gmail.com

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