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Completed

NCT Number: NCT06973265

Effects of Transcutaneous Electrical Nerve Stimulation on Breast Surgery

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.

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Key information

Conditions

Breast Cancer Surgery Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Mobility Limitation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Transcutaneous Electric Nerve Stimulation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, 38260, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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.

  2. Lymphedema severity

    Time frame: 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.

  3. Shoulder and arm mobility

    Time frame: 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 outcomes

  1. Upper extremity functions

    Time frame: 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.

  2. Cancer Related Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seda Akutay

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Lymphedema, Upper Extremity Functions, and Quality of Life in Patients Undergoing Breast Surgery After Neoadjuvant Chemotherapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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