Effects of Transcutaneous Electrical Nerve Stimulation on Breast Surgery

NCT ID: NCT06973265

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-08-01

Brief Summary

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The aim of this randomized controlled trial was to evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on postoperative pain, lymphedema development, shoulder range of motion, and quality of life in women undergoing breast cancer surgery after neoadjuvant chemotherapy. The main questions it aims to answer are:

Does TENS reduce postoperative pain? Does TENS prevent postoperative lymphedema? Does TENS increase postoperative shoulder range of motion? Does TENS improve postoperative quality of life? The researchers will compare the effects of TENS after breast surgery with a control group.

Participants will be assessed for pain, lymphedema development, and shoulder range of motion before surgery, on the first day after surgery, at the first month after surgery, and at the third month after surgery. Quality of life will be assessed before surgery, at the first month after surgery, and at the third month after surgery.

Detailed Description

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Conditions

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Breast Cancer Surgery Transcutaneous Electric Nerve Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TENS group and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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TENS group

Patients in this group will receive TENS treatment for 1 month after surgery.

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

After the surgery, 2 TENS electrodes will be placed on the inner part of the upper arm of the patient's arm on the side where surgery was performed, and the frequency will be 100 Hz, the pulse duration will be 100 µs and the amplitude will be adjusted so as not to cause muscle contraction, and a 20-minute TENS application will be performed.

Control group

Patients in this group do not receive TENS application after surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TENS

After the surgery, 2 TENS electrodes will be placed on the inner part of the upper arm of the patient's arm on the side where surgery was performed, and the frequency will be 100 Hz, the pulse duration will be 100 µs and the amplitude will be adjusted so as not to cause muscle contraction, and a 20-minute TENS application will be performed.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Those whose primary cancer tissue is breast
* ASA classification is between I and III
* Having unilateral breast surgery

Exclusion Criteria

* Those with cardiac problems and those using a pacemaker
* Pregnant
* Cognitively impaired
* Disruption of skin integrity in the TENS application area
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Seda Akutay

OTHER

Sponsor Role lead

Responsible Party

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Seda Akutay

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Erciyes University

Kayseri, Kayseri, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Akutay S, Yuceler Kacmaz H, Ceyhan O. The healing power of transcutaneous electrical nerve stimulation: a systematic review on its effects after breast surgery. Support Care Cancer. 2025 Jan 13;33(2):90. doi: 10.1007/s00520-024-09129-3.

Reference Type BACKGROUND
PMID: 39804405 (View on PubMed)

Other Identifiers

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EUniversity

Identifier Type: -

Identifier Source: org_study_id

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