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Transcutaneous Electrical Nerve Stimulation Post-thoracic Surgery in a Intensive Care Unit (TENS)

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ClinicalTrials.gov Identifier: NCT02438241
Recruitment Status : Unknown
Verified December 2014 by Hermann Heinrich Husch, Irmandade Santa Casa de Misericórdia de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Hermann Heinrich Husch, Irmandade Santa Casa de Misericórdia de Porto Alegre

Brief Summary:
Introduction: Pain is an important factor of increase of morbidity and mortality in patients undergoing surgical procedures include thoracotomy. There are different methods of analgesia in postoperative thoracic surgery, ranging from systemic analgesia with opioids, as well as local anesthetics block (intrapleural, extrapleural, intercostal cryoanalgesia, etc.) in addition to spinal blocks and Epidural blocks. In the pharmacological analgesia, electroanalgesia has been proposed as an adjunctive treatment for the relief of postoperative pain. Rationale: noting the lack of data in the literature regarding the use of this physical therapy technique in order to reduce the pain in the postoperative period of thoracic surgery and its consequences, it is relevant to the realization of a new randomized controlled trial (RCT) to evaluate the effects of transcutaneous electrical nerve (TENS) in the post - thoracic surgery on pain, pulmonary function and strength respiratory muscle. Objective: To evaluate the effects of TENS on pain, respiratory muscle strength and lung function in postoperative thoracic surgery in a Intensive Care Unit. Method: The subjects included will be randomized into three groups randomly: control group (CG) that will hold only conventional physical therapy, TENS group (EG) that will hold the application of TENS associated with conventional physical therapy, TENS placebo group (GP) who will perform the application of TENS placebo to conventional therapy. All groups carry out the assessments (digital manometer, spirometry, visual analog pain scale) in the preoperative period, postoperative Immediate / pre-intervention and at the end of treatment (discharge from the intensive care unit), except for the pain that will be evaluated before and after each intervention session. All patients receive physical therapy three times a day (morning, afternoon and evening) during hospitalization in the intensive care unit. Intervention: The conventional group will receive conventional therapy for hospital service. The TENS group will receive conventional therapy and the end of that service, will be applied TENS for 30 minutes. The placebo TENS group will receive the conventional physical therapy and the end of the service will be installed TENS placebo, during this period the patient receives electrical stimulation for 45 seconds, shutting down at the end of this time and held position as TENS group.

Condition or disease Intervention/treatment Phase
Thoracic Surgery Procedure: Conventional physiotherapy Group Procedure: TENS Group Procedure: Placebo TENS group Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Nerve Stimulation Post-thoracic Surgery in a Intensive Care Unit: Randomized Clinical Trial
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: Conventional physiotherapy Group
Patients randomized to this group will receive only conventional physiotherapy. The treatment protocol will consist of weathered active exercises to manually lower limbs in bed (triple flexion, abduction and adduction, plantar / dorsiflexion), free active exercises of the upper limbs in the bed (shoulder flexion, shoulder flexion and horizontal functional diagonal shoulder), bronchial hygiene techniques, flow redirection, positive expiratory pressure and ventilatory blowing patterns.
Procedure: Conventional physiotherapy Group
Patients randomized to this group will receive only conventional physiotherapy. The treatment protocol Control Group, will consist of weathered active exercises to manually lower limbs in bed (triple flexion, abduction and adduction, plantar / dorsiflexion), free active exercises of the upper limbs in the bed (shoulder flexion, shoulder flexion and horizontal functional diagonal shoulder), bronchial hygiene techniques, flow redirection, positive expiratory pressure and ventilatory blowing patterns.

Placebo Comparator: Placebo TENS Group
Will be held the same procedure as TENS group, except that TENS will be offered to the patient only for 45 seconds, and in the first 30 seconds is reached the sensory threshold of the patient and in the last 15 seconds will turn off the electrical current by 29 remaining period minutes and 15 seconds off.
Procedure: Placebo TENS group
Patients randomized to this group will receive conventional physical therapy (the treatment protocol Control Group), will be held the same procedure as TENS group, except that TENS will be offered to the patient only for 45 seconds, and in the first 30 seconds is reached the sensory threshold of the patient and in the last 15 seconds will turn off the electrical current by 29 remaining period minutes and 15 seconds off.

Experimental: TENS group
Patients randomized to this group will receive conventional physical therapy for the control group, and the end of that service, will be applied TENS. TENS is accomplished through the use of an electrical stimulation device with symmetrical biphasic current pulse. The following parameters are used: frequency: 100 Hz, pulse width: 100 µs, intensity to the greatest sensory threshold of the patient and total session time: 30 minutes. Self-adhesive electrodes will be used (Valutrode, size 5x9 cm) to be positioned in the posterolateral portion of the chest to 2 cm skin incision both upper and lower.
Procedure: TENS Group
Patients randomized to this group will receive conventional physical therapy (the treatment protocol Control Group), and the end of that service, will be applied TENS. TENS is accomplished through the use of an electrical stimulation device with symmetrical biphasic current pulse. The following parameters are used: frequency: 100 Hz, pulse width: 100 µs, intensity to the greatest sensory threshold of the patient and total session time: 30 minutes. Self-adhesive electrodes will be used (Valutrode, size 5x9 cm) to be positioned in the posterolateral portion of the chest to 2 cm skin incision both upper and lower.




Primary Outcome Measures :
  1. Assess the pain of change in postoperative thoracic surgery [ Time Frame: 3 days ]
    It will be used a visual analogous scale to assess pain after each service physiotherapy



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Will be included patients between 30 and 75 years;
  • Both sexes;
  • Post-thoracic surgery with posterolateral thoracotomy incision for pulmonary resection (Bullectomy, segmentectomy, lobectomy, pneumonectomy);
  • Evaluated between 4-6 hours after entry into the intensive care unit;
  • Hemodynamic stability (mean arterial pressure between 60 mmHg and 100 mmHg, heart rate between 50 bpm and 110 bpm, peripheral saturation greater than 90%);
  • Patients who have liquid drainage chest tubes in less than 300 ml for six hours;
  • Scale agitation-sedation Richmond (RASS) between -1 and +1;
  • Prescription physical therapy;
  • Have epidural or Paravertebral catheter;
  • Agree to participate in the study by signing the Informed Consent and Informed (IC ).

Exclusion Criteria:

  • Not intubated with up to 6 hours in the immediate postoperative period;
  • Primary pulmonary disease not rise (cardiovascular, neurological diseases);
  • Hemodynamic instability (with pressure mean blood less than 60 mmHg or greater 100 mmHg, heart rate less than 49 bpm and greater than 111 bpm, reduced peripheral saturation of 90%);
  • Patients who have the upper drainage liquid drains to 300 ml for six hours;
  • Scale agitation-sedation Richmond (RASS) between -5 and -2, and agitated / aggressive patients, scale agitation-sedation Richmond RASS +2 and +4;
  • Prescribing physical therapy;
  • Without epidural or paravertebral catheter;
  • Patients who do not accept the study, not collaborative and do not sign the informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438241


Locations
Brazil
Irmandade Santa Casa de Misericórdia
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Sponsors and Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
Investigators
Study Director: Graciele Sbruzzi, doctor Federal University of Rio Grande do Sul

Additional Information:
Publications of Results:

Responsible Party: Hermann Heinrich Husch, Physiotherapist intensive care unit, Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier: NCT02438241     History of Changes
Other Study ID Numbers: 36851514.6.0000.5335
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: December 2014

Keywords provided by Hermann Heinrich Husch, Irmandade Santa Casa de Misericórdia de Porto Alegre:
Pain Measurement
Electric Stimulation
Spirometry
Manometry