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Effect of intensity of electric current and evidence of blinding method

Effect of intensity of interferential current and validation of the placebo method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8h32gy
Enrollment
Unknown
Registered
2015-08-17
Start date
2012-08-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified pain

Interventions

The subjects were randomly divided into five groups, described as follows: Adjusted motor group: 25 participants of both sexes were recruited, the interferential current (IFC) was applied for 30 minut
at intervals of 5 minutes, the intensity was increased again until a strong sensation. Fixed motor group: 25 participants of both sexes were recruited, the IFC was applied for 30 minutes at a frequenc
this intensity was maintained at this level throughout the procedure. Sensory group: 25 participants of both sexes were recruited, the IFC was applied for 30 minutes at a frequency of 100Hz, the inten
the subjects were connected to the device for 30 minutes. New placebo group: 25 participants of both sexes were recruited, an external device, manufactured exclusively for this study, was connected to
the subjects were connected to the device for 30 minutes. In all groups, the electrodes were placed on the subject's forearm.
Other
D26.660

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Universidade Federal de Sergipe
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy subjects; 18 to 60 years of age.

Exclusion criteria

Exclusion criteria: Participants with peripheral nerve injury in the upper limbs; presence of pain in the upper limbs; pregnancy; chronic diseases; use of cardiac pacemaker; epilepsy; allergy to the material of the electrodes; current use of analgesic medication or in the last seven days; altered skin conditions or loss of sensation in the established areas of electrode placement.

Design outcomes

Primary

MeasureTime frame
Over 50% of subjects, included in the new placebo group, respond receiving an active treatment, when questioned by the investigator immediately after the intervention.;At the end of the study, it was observed a percentage of 60% of subjects, included in the new placebo group, who believed they received active treatment.

Secondary

MeasureTime frame
Let there be no significant changes in the pressure pain threshold, measured by digital algometry, in the cutaneous sensitive threshold, measured by esthesiometry, and in the pain intensity, measured by 11-point numerical rating scale, after intervention in the placebo groups, from the observation of a greater variation than 5% in pre and post treatment.;At the end of study, none of the placebo groups significantly altered the pressure pain threshold, cutaneous sensitive threshold and pain intensity after treatment, presenting a difference greater than 5% of pretreatment value. Only in the adjusted motor group there was significant change less than 5% in all variables.

Countries

Brazil

Contacts

Public ContactFernanda Araújo

Universidade Federal de Sergipe

nanda.maraujo@hotmail.com+55(79)32312841

Outcome results

None listed

Source: REBEC (via WHO ICTRP)