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Electrical stimulation effect to diminish pain on arm in women undergoing surgery for breast cancer

Electrical Analgesia Effect On Dysestesia In Women Undergoing To Axillary Linfadenectomy - : Electrical analgesia effect on Dysestesia in women undergoing to Axillary Linfadenectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3s39jp
Enrollment
Unknown
Registered
2013-10-03
Start date
2011-06-20
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

postoperative breast neoplasm, paresthesia, removal of lymph

Interventions

Was recruited 32 women, aged between 18 and 80 years and randomized into two groups: Transcutaneous Electrical Nerve Stimulation (TENS
)active TENS (treated group n = 16) and placebo TENS (control group n = 16). The patients in the active TENS group underwent 20 sessions, 3x per week on alternate days- parameters: Frequency = 100Hz,
Other
HP3.073.433.101

Sponsors

CNPq- Conselho Nacional de Desenvolvimento Científico e Tecnológico
Lead Sponsor
Núcleo de Pós-Graduação em Medicina da Universidade Federal de Sergipe
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Axillary lymphadenectomy for breast cancer, the presence of changes in skin sensitivity intercostal nerve pathway, ASA I or II; absence of cognitive disorders, hearing and visual

Exclusion criteria

Exclusion criteria: Attendance: skin lesions, active infectious processes; erysipelas; girth greater than 4 cm, breast reconstruction, bilateral mastectomy, neurological diseases, use of certain drugs such as anlagesic and antiinflammatory, use of a cardiac pacemaker; morbid obesity.

Design outcomes

Primary

MeasureTime frame
It is expected that after 20 sessions of Transcutaneous Electrical Nerve Stimulation (TENS) to dysesthesia caused by nerve damage intercostobrachial (NICB) in women undergoing axillary lymphadenectomy is decreased. Was used to calculate the sample based on previously published studies with methodological design and similar areas of study. Estimating a level of significance of 5% and a power of 75% was calculated sample size of approximately 15 subjects per group.;After 20 sessions of Transcutaneous Electrical Nerve Stimulation (TENS)the dysesthesia caused by intercostobrachial nerve (ICBN)injury decreased in women undergoing axillary lymphadenectomy.

Secondary

MeasureTime frame
The intensity of discomfort in the arm (measured by the Visual Analogue Scale-VAS) ipsilateral decreased significantly after 20 sessions of TENS in TENS group active, but compared with the placebo TENS group, no difference was found. Cutaneous sensitivity (assessed by esthesiometry) and pressure pain threshold (assessed by algometry) did not change after the intervention in either group. The quality of life (as measured by the EORTC QLQ C30 and BR23) is not modified significantly after the treatment in both groups. ;It is expected that the intensity of discomfort in the arm (measured by the Visual Analogue Scale-VAS) ipsilateral diminished significantly after 20 sessions of TENS in TENS group active. And that skin sensitivity (assessed by esthesiometry) and pressure pain threshold (assessed by algometry) are changed after the intervention in the active TENS group. The quality of life (assessed by the EORTC QLQ C30 and BR23) improves significantly after treatment in the active TENS group.

Countries

Brazil

Contacts

Public ContactMariana Rett

Hospital Universitário (HU) da Universidade Federal de Sergipe (UFS)

marianatrb@gmail.com+55 (79) 21051804

Outcome results

None listed

Source: REBEC (via WHO ICTRP)