Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000480280
Ethics application status
Approved
Date submitted
11/12/2008
Date registered
18/06/2009
Date last updated
18/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of the stimulating frequency involved in analgesia by electroacupuncture
Scientific title
Study by stimulatory frequency in analgesia with electroacupuncture
Universal Trial Number (UTN)
Trial acronym
Cervical pain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assess what is the best attendance in stimulatory electro-acupuncture for analgesia in cervical pain 4122 0
Condition category
Condition code
Alternative and Complementary Medicine 4317 4317 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
66 volunteers were treated with cervical pain, stimuation in trapezius muscles, by electroacupunture divided into 5 groups. Each group was treated with different frequencies stimulatory (2, 100, 1000, 2500 Hz and a group only with acupuncture). 66 volunteers received only one session by 20 minutes each. The electroacupuncture is a electrical
stimulation in the needles acupuncture. The eletroacupuncture was administred to the trapezius muscles in the acupoint denomination tianliao and jianjing.
Intervention code [1] 3831 0
Rehabilitation
Comparator / control treatment
One group with acupuncture, without electrical stimulation in the same points (trapezius muscles). Received only one session by 20 minutes each.
Control group
Active

Outcomes
Primary outcome [1] 5207 0
The study was without use drugs by analgesic. Primary outcome: All the frequencies stimulations with acupuncture are analgesics after 10 minutes your aplication by analogical visual escale (EAV) and algometry.
Timepoint [1] 5207 0
Before 10 minutes and after 10 minutes by acupuncture.
Primary outcome [2] 238115 0
The study was without use drugs by analgesic. Primary outcome: All the frequencies stimulations with acupuncture are analgesics after 10 minutes your aplication by analogical visual escale (EAV) and algometry.
Timepoint [2] 238115 0
Before 10 minutes and after 10 minutes by acupuncture.
Secondary outcome [1] 242459 0
"Nil"
Timepoint [1] 242459 0
"Nil"

Eligibility
Key inclusion criteria
Tensional cervical pain;
Minimum age
18 Years
Maximum age
53 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnat;
smoking;
eplepsy
without use drugs by analgesic

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)
Have been pre-selected volunteers with cervical tension in accordance with inclusion criteria. The Stimulatory frequency tested (2, 100, 1000, 2500 Hz) or only with acupuncture was choose by drawn randomly tested with numberes containers. The evaluation of clinical response (analgesia) was performed by an external evaluator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Method of distribution of volunteers in the groups was distributed systematically by simple randomisation. There was a draw of groups (2, 100, 1000, 2500 Hz and only acupuncture) and its correlation with the numbers 1, 2, 3, 4 and 5. As the volunteers went to the treatment session take in a box drawn one of the numbers 1, 2, 3, 4 and 5. An external evaluator conducted the sweepstakes, and adjusted the stimulatory frequencies without the researcher knew which was being used at that time. The correspondence group with the results appeared only after the statistical treatment. Don't was selection of groups by age or gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Were five uniforms groups with cervical pain, by the criteria of inclusion. In each group the only variable stimulatory was the frequency of which was the objective research
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 1471 0
Brazil
State/province [1] 1471 0
parana

Funding & Sponsors
Funding source category [1] 4281 0
Other Collaborative groups
Name [1] 4281 0
IBRATE - Instituto Brasileiro de Therapias e Ensino
Country [1] 4281 0
Brazil
Funding source category [2] 237132 0
Self funded/Unfunded
Name [2] 237132 0
Sandra Mara Silverio-Lopes
Country [2] 237132 0
Brazil
Primary sponsor type
Individual
Name
Sandra Mara Silverio-Lopes
Address
Rua Voluntarios da Patria, 215 - 2 andar - Curitiba-Pr. - 80020-000
Country
Brazil
Secondary sponsor category [1] 4668 0
None
Name [1] 4668 0
Address [1] 4668 0
Country [1] 4668 0
Other collaborator category [1] 507 0
University
Name [1] 507 0
Pontificia Universidade Catolica do Parana
Address [1] 507 0
Rua Imaculada Conceicao, 1155 Curitiba-Pr.- 80215-901
Country [1] 507 0
Brazil
Other collaborator category [2] 508 0
Individual
Name [2] 508 0
Percy Nohama
Address [2] 508 0
Rua Imaculada Conceicao, 1155 - Curitiba - Pr. - 80215-901
Country [2] 508 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6334 0
Comite de Etica da Pontificia Universidade Catolica do Parana
Ethics committee address [1] 6334 0
Rua Imaculada Conceicao 1155 - Curitiba - pr.- 80215-901
Ethics committee country [1] 6334 0
Brazil
Date submitted for ethics approval [1] 6334 0
22/03/2006
Approval date [1] 6334 0
26/04/2006
Ethics approval number [1] 6334 0
1035

Summary
Brief summary
The goal of this research is the avaluation of the influence of the electrical stimulation frequency on the induced analgesia for tensional cervical pain. For the development of the experimental protocol, a micropocessed electrical stimulation system yielding a non-symmetrical. balanced, rectangular pulse. The tested frequency was 2, 100, 1000, 2500 hz. and one group only by acupuncture. The instruments for avaluation and comparison were applied: pressure algometry, analog visual scale and cardiac frequency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35035 0
Address 35035 0
Country 35035 0
Phone 35035 0
Fax 35035 0
Email 35035 0
Contact person for public queries
Name 12382 0
Sandra Mara Silverio-Lopes
Address 12382 0
Rua Voluntarios da Patria, 215 - 2 andar - CEP: 80020-000 - Curitiba - Parana.
Country 12382 0
Brazil
Phone 12382 0
55-41-32251844
Fax 12382 0
55-41-32251844
Email 12382 0
[email protected]
Contact person for scientific queries
Name 3310 0
Sandra Mara Silverio-Lopes
Address 3310 0
Rua Voluntarios da Patria, 215 - 2 andar - CEP: 80020-000 - Curitiba - Parana.
Country 3310 0
Brazil
Phone 3310 0
55-41-32251844
Fax 3310 0
55-41-32251844
Email 3310 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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