Effects of Transcutaneous Electrical Nerve Stimulation on Breast Surgery

NCT06973265 | Completed

• 1 other identifier: EUniversity
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Surgery; Transcutaneous Electric Nerve Stimulation

Keywords

pain; lymphedema; Mastectomy; Mobility Limitation; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Until the end of 3 month

Secondary Outcomes (2)

• Upper extremity functions

  Preoperative period, postoperative 1 month and postoperative 3 month

• Cancer Related Quality of Life

  Preoperative period, postoperative 1 month and postoperative 3 month

Study Arms (2)

TENS group

EXPERIMENTAL

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

Device: TENS

Control group

NO INTERVENTION

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

Interventions

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.

TENS group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seda Akutay: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38260, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39804405 BACKGROUND

MeSH Terms

Conditions

Pain; Lymphedema; Mobility Limitation

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: TENS group and control group

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-05

Locations

TU (1)