NCT04800640

Brief Summary

It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

March 23, 2020

Last Update Submit

March 13, 2021

Conditions

Bariatric SurgeryObesity, Morbid

Keywords

SpirometryElectroanalgesiaBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • As a primary endpoint, pain using the visual analog pain scale.

    This scale is considered valid to predict the level of pain in the postoperative period of bariatric surgery. The value being zero without pain and ten maximum pain.

    5 days.

Secondary Outcomes (2)

  • Evaluate changes in the strength of respiratory muscles, using manovacuometry.

    5 days.

  • To evaluate lung function in patients in the postoperative period of bariatric surgery using spirometry.

    5 days.

Study Arms (2)

No Electroanalgesia

NO INTERVENTION

The sample will consist of 132 individuals, of both sexes, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia through TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia

Electroanalgesia

EXPERIMENTAL

The sample will consist of 132 individuals, of both sexes, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia through TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia

Other: Experimental: Electroanalgesia

Interventions

Experimental: ElectroanalgesiaOTHER

The sample will consist of 66 individuals, of both men and women, where they will be randomly included in two groups: Intervention group composed of 33 patients who will effectively receive the treatment through electroanalgesia via TENS;

Electroanalgesia

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • This research will include patients who are in the postoperative period of bariatric surgery and who are aged 18 years or over

You may not qualify if:

  • Patients over the age of 50;
  • Individuals who present hemodynamic instability in the postoperative period;
  • Use of mechanical ventilation for more than 24 hours;
  • Contraindications regarding the use of TENS (presence of a cardiac pacemaker, hypersensitivity regarding the use of TENS);
  • Previous history of epilepsy;
  • Pregnant women during the first trimester;
  • Patients with a score, on the Glasgow coma scale (Appendix I), less than 15;
  • Patients who choose to withdraw during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro universitário augusto motta

Rio de Janeiro, Rio de Janeiro, 21041-020, Brazil

RECRUITING

Related Publications (5)

  • Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, Mancuso M, Ruffini E, Maggi G. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997 Mar;63(3):773-6. doi: 10.1016/s0003-4975(96)01249-0.

    PMID: 9066400BACKGROUND

  • 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: 12600800BACKGROUND

  • Cipriano G Jr, de Camargo Carvalho AC, Bernardelli GF, Tayar Peres PA. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):539-43. doi: 10.1510/icvts.2007.168542. Epub 2008 Apr 16.

    PMID: 18417519BACKGROUND

  • Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. doi: 10.1007/s00268-005-7934-6.

    PMID: 16331341BACKGROUND

  • Luchesa CA, Lopes AJ. Role of Transcutaneous Electric Nerve Stimulation in Pain and Pulmonary Function in Patients after Bariatric Surgery. Rehabil Res Pract. 2022 Jun 2;2022:9138602. doi: 10.1155/2022/9138602. eCollection 2022.

    PMID: 35692935DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cesar A Luchesa, MSc

    Centro Universitário FAG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar A Luchesa, MSc

CONTACT

55 (45) 984228189fisioterapia_ala@saolucas.fag.edu.br

Agnaldo J Lopes, PHd

CONTACT

55 (21) 99853-6162agnaldolopes.uerj@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
He sample will consist of 132 individuals, of both men and women, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia via TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia. For division of groups, a sortition will be carried out through envelopes where it will be decided to which study group the patient will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is an uncontrolled cross-sectional clinical trial with a sample of 132 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 16, 2021

Study Start

June 1, 2019

Primary Completion

July 1, 2021

Study Completion

October 30, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)