Effects of Transcutaneous Electrical Nerve Stimulation on Breast Surgery

Not Applicable

• Conditions: Breast Cancer Surgery; Transcutaneous Electric Nerve Stimulation

• Registration Number: NCT06973265
• Lead Sponsor: Seda Akutay

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	Until the end of 3 month	The Visual Analog Scale (VAS) scale will be used to assess pain intensity. It is a 10 cm line with connecting expressions on the left (no pain) and on the right (extreme pain). The patient is asked to mark the current pain level on the line. It means that the pain intensity increases as you move from left to right.
Lymphedema severity	Until the end of 3 month	A tape measure will be used to assess the severity of lymphedema. Measurements will be made bilaterally at 6 different points (Hand circumference, wrist, 15 cm below the elbow, 7,5 cm below the elbow, 7,5 cm above the elbow, 15 cm above the elbow )on the arm.
Shoulder and arm mobility	Until the end of 3 month	Shoulder range of motion (flexion, extension, abduction, internal rotation and external rotation angles of the arm) was measured with a goniometer.

Secondary Outcome Measures

Name	Time	Method
Upper extremity functions	Preoperative period, postoperative 1 month and postoperative 3 month	The Quick Disability of the Arm, Shoulder and Hand (QuickDASH) Questionnaire and hand dynamometer will be used. In QuickDASH, a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.
Cancer Related Quality of Life	Preoperative period, postoperative 1 month and postoperative 3 month	European Organization for Cancer Research and Treatment Quality of Life Questionnaire-30- EORTC QLQ-C30 will be used.

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Turkey