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

NCT06202794 | Unknown

• 1 other identifier: 18072023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Pain after breast plastic surgery affects quality of life. Physical therapy offers effective interventions for this condition, such as transcutaneous electrical nerve stimulation (TENS). Although this resource has been used for more than 20 years, no studies have been published that support its use following this type of surgery. Therefore, the aim of the proposed study is to evaluate the effect of TENS on pain intensity in patients undergoing mastopexy with implants, given the existing evidence on the success of TENS for other conditions. Methods: A two-arm, randomized, sham-controlled trial will be conducted with blinded assessors. The study will be carried out at the Exercise Physiology and Metabolism Lab of Finis Terrae University. Eligible participants will be women undergoing mastopexy with implants invited by a board-certified plastic surgeon. The participants will be randomly assigned to one of two study groups: Group 1 (surgery + TENS) and Group 2 (surgery + sham TENS). TENS will be administered only one hour after surgery and will remain for one hour. Four assessments will be performed: before treatment (T0), immediately after treatment (T1), one hour (T2) and four hours after TENS (T3). The primary outcome will be pain intensity at rest, pain intensity during movement (standardized movements of both arms: anterior flexion, abduction, and external rotation), and during respiratory function tests. Secondary outcome measures will be maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and vital capacity (VC). Discussion In this study, the effects of TENS on patients with pain following mastopexy with implants will be compared to the effects of a sham TENS intervention. This RCT will offer novel evidence on the potential benefits of TENS in terms of pain intensity at rest as well as during movements and respiratory function tests. Keywords TENS, Mastopexy, Plastic Surgery, Physical therapy modalities, Clinical trial protocol

Conditions

Postoperative Pain; Respiratory Complication

Keywords

TENS; Plastic Surgery; Physical therapy modalities

Outcome Measures

Primary Outcomes (2)

• Pain intensity at rest

  The primary outcome will be pain intensity, which will be measured using the numeric rating scale (NRS). The NRS is a simple, easy-to-use scale on which the respondent is asked to rate the intensity of current pain using a scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). This tool has established validity and reliability for measuring acute and postoperative pain intensity. It also has similar sensitivity and correlates to the visual analogue scale.

  This will be performed at rest immediately after the intervention (T1), 1 hour after treatment (T2) and 4 hour after treatment (T3)

• Pain intensity during movement

  The primary outcome will be pain intensity, which will be measured using the numeric rating scale (NRS). The NRS is a simple, easy-to-use scale on which the respondent is asked to rate the intensity of current pain using a scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). This tool has established validity and reliability for measuring acute and postoperative pain intensity. It also has similar sensitivity and correlates to the visual analogue scale.

  This will be performed during movement of arms immediately after the intervention (T1), 1 hour after treatment (T2) and 4 hour after treatment (T3)

Secondary Outcomes (3)

• Maximum Inspiratory Pressure (MIP)

  Immediately after treatment (T1), 1 h after treatment (T2) and 4 h after treatment (T3)

• Maximum Expiratory Pressure (MEP)

  Immediately after treatment (T1), 1 h after treatment (T2) and 4 h after treatment (T3)

• Vital Capacity (VC)

  Immediately after treatment (T1), 1 h after treatment (T2) and 4 h after treatment (T3)

Study Arms (2)

Experimental group

EXPERIMENTAL

TENS will be initiated one hour after surgery. A portable device with two channels will be used (Neurodyn Portable TENS, Ibramed, Amparo, São Paulo, Brazil). This device will deliver a biphasic, asymmetrical, balanced current, with a frequency of 100 Hz and pulse duration of 100 μs. Four electrodes (5x5 cm) will be positioned on the left and right sides of the spine according to the indicated instructions. The assessor will increase the intensity to promote a strong tingling sensation, reaching the patient's maximum tolerance level without causing discomfort. Emission will be applied in a single session of one continuous hour and the patients will be informed that the sensation may decrease over time. Every 10 minutes, the assessor will ask the patient if there is habituation to the current and will increase the intensity if necessary. TENS will be administered only once for one hour.

Device: Experimental: Experimental group

Control group

SHAM COMPARATOR

Sham TENS will be performed using equipment identical in appearance to active TENS (Neurodyn Portable TENS, Ibramed, Amparo, São Paulo, Brazil) specifically designed for this study. The device will emit an electrical current gradually increased during the first 30 seconds, followed by a gradual decrease over the subsequent 15 seconds reaching an intensity of 0 mA. The device will remain inactive during the rest of the application, but will have a flashing light, giving the patient the appearance that it is active. The assessor will inform the patient that it is possible to feel the sensation of the current or not depending on individual characteristics. This type of equipment is validated and has been used in other studies to facilitate the blinding of participants. Both systems will be calibrated using a digital oscilloscope (DPO 7000, Tektronix Inc., Beaverton, OR, USA).

Device: Sham Comparator: Control group

Interventions

Experimental: Experimental group DEVICE

TENS will be initiated one hour after surgery. A portable device with two channels will be used (Neurodyn Portable TENS, Ibramed, Amparo, São Paulo, Brazil). This device will deliver a biphasic, asymmetrical, balanced current, with a frequency of 100 Hz and pulse duration of 100 μs. Four electrodes (5x5 cm) will be positioned on the left and right sides of the spine according to the indicated instructions. The assessor will increase the intensity to promote a strong tingling sensation, reaching the patient's maximum tolerance level without causing discomfort. Emission will be applied in a single session of one continuous hour and the patients will be informed that the sensation may decrease over time. Every 10 minutes, the assessor will ask the patient if there is habituation to the current and will increase the intensity if necessary. TENS will be administered only once for one hour.

Also known as: TENS Experimental group

Experimental group

Sham Comparator: Control group DEVICE

Sham TENS will be performed using equipment identical in appearance to active TENS (Neurodyn Portable TENS, Ibramed, Amparo, São Paulo, Brazil) specifically designed for this study. The device will emit an electrical current gradually increased during the first 30 seconds, followed by a gradual decrease over the subsequent 15 seconds reaching an intensity of 0 mA. The device will remain inactive during the rest of the application, but will have a flashing light, giving the patient the appearance that it is active. The assessor will inform the patient that it is possible to feel the sensation of the current or not depending on individual characteristics. This type of equipment is validated and has been used in other studies to facilitate the blinding of participants. Both systems will be calibrated using a digital oscilloscope (DPO 7000, Tektronix Inc., Beaverton, OR, USA).

Also known as: Sham TENS Experimental group

Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Finis Terrae University: lead

Study Sites (1)

Esteban Fortuny

Santiago, Santiago Metropolitan, 7510447, Chile

Location

Related Publications (14)

• Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.

  PMID: 12600800 RESULT

• da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.

  PMID: 25665520 RESULT

• DeSantana JM, Santana-Filho VJ, Guerra DR, Sluka KA, Gurgel RQ, da Silva WM Jr. Hypoalgesic effect of the transcutaneous electrical nerve stimulation following inguinal herniorrhaphy: a randomized, controlled trial. J Pain. 2008 Jul;9(7):623-9. doi: 10.1016/j.jpain.2008.01.337. Epub 2008 Apr 3.

  PMID: 18387854 RESULT

• Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097/AJP.0b013e31817d1070.

  PMID: 19158541 RESULT

• Ducic I, Seiboth LA, Iorio ML. Chronic postoperative breast pain: danger zones for nerve injuries. Plast Reconstr Surg. 2011 Jan;127(1):41-46. doi: 10.1097/PRS.0b013e3181f9587f.

  PMID: 21200198 RESULT

• Emmiler M, Solak O, Kocogullari C, Dundar U, Ayva E, Ela Y, Cekirdekci A, Kavuncu V. Control of acute postoperative pain by transcutaneous electrical nerve stimulation after open cardiac operations: a randomized placebo-controlled prospective study. Heart Surg Forum. 2008;11(5):E300-3. doi: 10.1532/HSF98.20081083.

  PMID: 18948245 RESULT

• Freynet A, Falcoz PE. Is transcutaneous electrical nerve stimulation effective in relieving postoperative pain after thoracotomy? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):283-8. doi: 10.1510/icvts.2009.219576. Epub 2009 Nov 12.

  PMID: 19910359 RESULT

• Galli TT, Chiavegato LD, Liebano RE. Effects of TENS in living kidney donors submitted to open nephrectomy: a randomized placebo-controlled trial. Eur J Pain. 2015 Jan;19(1):67-76. doi: 10.1002/ejp.521. Epub 2014 May 15.

  PMID: 24831862 RESULT

• Galli TT, Chiavegato LD, Santiago NR, Liebano RE. Effects of transcutaneous electrical nerve stimulation on pain, walking function, respiratory muscle strength and vital capacity in kidney donors: a protocol of a randomized controlled trial. BMC Nephrol. 2013 Jan 11;14:7. doi: 10.1186/1471-2369-14-7.

  PMID: 23311705 RESULT

• Liebano RE, Vance CG, Rakel BA, Lee JE, Cooper NA, Marchand S, Walsh DM, Sluka KA. Transcutaneous electrical nerve stimulation and conditioned pain modulation influence the perception of pain in humans. Eur J Pain. 2013 Nov;17(10):1539-46. doi: 10.1002/j.1532-2149.2013.00328.x. Epub 2013 May 6.

  PMID: 23650092 RESULT

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 RESULT

• Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

  PMID: 14622708 RESULT

• Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022 Feb 10;12(2):e051073. doi: 10.1136/bmjopen-2021-051073.

  PMID: 35144946 RESULT

• Pacheco EF, Lyons TV, Liebano RE. Effects of transcutaneous electrical nerve stimulation for the treatment of pain and respiratory function following mastopexy with augmentation: study protocol for a randomized controlled trial. Trials. 2025 Dec 2;27(1):7. doi: 10.1186/s13063-025-09231-9.

  PMID: 41331821 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Research Design

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Esteban Fortuny, PT

  Finis Terrae University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esteban Fortuny, PT

CONTACT

+56976693950; efortunyp@uft.edu

Richard Liebano, PhD, PT

CONTACT

+18608105563; liebano@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: After the website (https://www.randomizer.org) generates a number sequence, blind allocation will be performed using consecutively numbered opaque envelopes. The envelopes will be sealed and stored in a secure cabinet. The main investigator will perform sample randomization and blind assignment. The researcher in charge of administering the treatments will open the envelopes immediately prior to the intervention. The patient, researcher and assessor will have no knowledge about the treatment applied (blinding of assessor and subjects). Only the researcher who administers the intervention (active or sham TENS) will have knowledge of the treatment and will instruct the participant not to provide information on the sensation of electrical stimulus to the assessor measuring pain levels.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy

Model Details: A two-arm, randomized, sham-controlled trial will be conducted with blinded assessors.

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 12, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)