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Search / Trial NCT06202794

TENS for the Treatment of Pain and Respiratory Function Following Mastopexy With Augmentation

Launched by FINIS TERRAE UNIVERSITY · Jan 10, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Tens Plastic Surgery Physical Therapy Modalities

ClinConnect Summary

This clinical trial is investigating whether a treatment called Transcutaneous Electrical Nerve Stimulation (TENS) can help reduce pain and improve breathing after breast surgery known as mastopexy with implants. After surgery, many women experience discomfort that can affect their recovery and quality of life. The study aims to see if using TENS shortly after surgery can make a difference in how much pain patients feel and how well they can breathe during recovery.

To participate in the trial, women aged 18 to 55 who are having this specific type of surgery and report moderate pain (a score greater than 3 on a pain scale) may be eligible. Participants will be randomly assigned to either receive TENS treatment or a placebo treatment that does not have any real effect. Throughout the study, their pain levels and breathing function will be carefully measured at different times after the treatment. This trial will provide valuable information on whether TENS could be a helpful tool for women recovering from this surgery.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • female sex, age between 18 to 55 years in the immediate postoperative period of mastopexy with implants;
  • score \> 3 for pain intensity on the numeric pain scale (NRS) reported during post-surgery screening;
  • no previous experience with the use of TENS or electrical currents for analgesia;
  • not having undergone any other type of surgery in the chest region, taking medications to control pain or anxiety, or having a history of pain in the breast region.
  • None of the individuals should use bronchodilator therapy or medications that directly act on the respiratory system.
  • Exclusion Criteria:
  • frequent use of bronchodilators, analgesics, muscle relaxants, or psychotropics or allergy to any medication that interferes with surgery (morphine, dipyrone, propofol, lidocaine);
  • pregnancy, previous abdominal surgeries, or pre-surgical breast pain;
  • any type of inflammatory disease, systemic lupus erythematosus, dermatomyositis or dermatitis in the treatment area, cancer, tumors of any type diagnosed in the previous five years;
  • history of epilepsy, metal devices implanted in the body;
  • any musculoskeletal injury in the cervical spine, neck or shoulder in the previous three months (fractures, sprains, tendinopathies, dislocations or muscle ruptures) or having a cardiac device, such as an internal automatic defibrillator or pacemaker.
  • All patients undergoing combined surgeries or who undergo another surgical procedure in addition to mastopexy with implants or who have knowledge or previous use of TENS or electrical currents for the treatment of pain will be excluded.

About Finis Terrae University

Finis Terrae University is a distinguished academic institution dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that promotes the integration of scientific inquiry and practical application in clinical settings. By leveraging state-of-the-art facilities and a commitment to ethical research practices, Finis Terrae University aims to contribute valuable insights to the medical community, ultimately enhancing patient care and outcomes. Their clinical trial initiatives reflect a robust commitment to improving health through evidence-based approaches and rigorous scientific methodologies.

Locations

Santiago, Metropolitana, Chile

Patients applied

0 patients applied

Trial Officials

Esteban Fortuny, PT

Principal Investigator

Finis Terrae University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported