An interventional study of TENS in Breast Cancer Surgery and Transcutaneous Electric Nerve Stimulation, sponsored by Seda Akutay. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Seda Akutay · Not applicable, Interventional, and Treatment
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.
2,226 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 48 is below the median of 70 across 1,911 interventional studies indexed under Pain.
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Exclusion Criteria:
Patients in this group will receive TENS treatment for 1 month after surgery.
Device: TENS
Patients in this group do not receive TENS application after surgery.
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.
Pain intensity
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.
Time frame: Until the end of 3 month
Lymphedema severity
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.
Time frame: Until the end of 3 month
Shoulder and arm mobility
Shoulder range of motion (flexion, extension, abduction, internal rotation and external rotation angles of the arm) was measured with a goniometer.
Time frame: Until the end of 3 month
Upper extremity functions
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.
Time frame: Preoperative period, postoperative 1 month and postoperative 3 month
Cancer Related Quality of Life
European Organization for Cancer Research and Treatment Quality of Life Questionnaire-30- EORTC QLQ-C30 will be used.
Time frame: Preoperative period, postoperative 1 month and postoperative 3 month
Plan to share: Undecided
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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