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Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03046212
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
Transcutaneous electrical nerve stimulation (TENS) is characterized by the application of an electric pulsed current through electrodes positioned on the skin. It can be an alternative for pain management after surgery for total hip arthroplasty (THA), since it is a safe and cost-effective therapeutic tool, allowing the patient to move early due to pain relief. Therefore, the study aims to evaluate the acute effects of TENS associated with standard physical therapy compared with standard physical therapy on the intensity of pain, hip range of motion and morphine consumption in the rehabilitation of patients after THA.

Condition or disease Intervention/treatment Phase
Transcutaneous Electric Nerve Stimulation Pain Device: Transcutaneous electrical nerve stimulation Other: Exercises Not Applicable

Detailed Description:
The study included patients who underwent THA surgery in the Hospital de Clínicas de Porto Alegre (HCPA) and met the study eligibility criteria. The sample was randomly divided into experimental group, which received conventional physical therapy associated with the application of TENS, and control group, which held only conventional physical therapy, both on the first day after the surgery. The pain level, the range of motion of the operated hip and the administration of morphine. The experimental group received TENS application held by four self-adhesive electrodes size 5x9cm positioned about five centimeters from the edges of the surgical scar. TENS was applied in conventional mode, emitting a pulsed biphasic, symmetrical rectangular wave with frequency of 100 Hz and pulse duration of 100 µs, for 30 minutes. The intensity was set according to the tolerance of the patient and was gradually increased during the application. The device used was the Neurodyn II model, by Ibramed. Subsequently, the conventional physical therapy was performed. The patients realized active exercises of plantar flexion and dorsal flexion of the ankles, flexion and extension of the knees and adduction and abduction of the hips, in both lower limbs. All exercises were performed with the patient in the supine position in the bed, in one serie of 10 repetitions. Control group received only conventional therapy consisting of the exercises in both lower limbs, identical to those performed in the experimental group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effects of Transcutaneous Electrical Nerve Stimulation in Patients Rehabilitation After Total Hip Arthroplasty
Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Electrical stimulation
This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
Device: Transcutaneous electrical nerve stimulation
TENS: it was applied in the conventional mode, through four self-adhesive electrodes of size 5x9cm positioned about five centimeters from the edges of the surgical scar, with frequency of 100 Hz and pulse duration of 100μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was it increased during the application time with their permission.
Other Name: TENS
Other: Exercises
Active exercises of plantar flexion and dorsal flexion of the ankles, flexion and extension of the knees and adduction and abduction of the hips, in both lower limbs. All exercises were performed with the patient in the supine position in the bed, in 10 repetitions.
Active Comparator: Physical therapy
This group received only conventional physical therapy (exercises).
Other: Exercises
Active exercises of plantar flexion and dorsal flexion of the ankles, flexion and extension of the knees and adduction and abduction of the hips, in both lower limbs. All exercises were performed with the patient in the supine position in the bed, in 10 repetitions.



Primary Outcome Measures :
  1. Change in Pain Level From Baseline to 45 Minutes [ Time Frame: baseline, 45 minutes ]
    It was measured by Visual Analogue Pain Scale (VAS), which has scores ranging from zero (which means "no pain") to 10 (which means "worst possible pain"). Two evaluations were performed in each group, before and after the interventions.


Secondary Outcome Measures :
  1. Change in Hip Range of Motion From Baseline to 45 Minutes [ Time Frame: baseline, 45 minutes ]
    Flexion and abduction movements were assessed by goniometry in the hip submitted to the surgery. Two evaluations were performed in each group, before and after the interventions.

  2. Number of Participants Who Received Morphine Within 24 Hours [ Time Frame: 24 hours ]
    It was evaluated based on the information found in patients' electronic records, considering whether they received morphine during the 24 hours following the interventions or not.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who underwent THA surgery due to primary or secondary coxarthrosis; both sexes; age between 40 and 90 years.

Exclusion Criteria:

  • patients who refused to participate of the study; THA indication for fractures and bone tumors; THA review surgery; postoperative infection; congenital anatomical alterations; neurological disorders; lack of understanding of commands; sensitivity alterations in the lower limbs; decompensated heart disease or cardiac pacemaker use.

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03046212     History of Changes
Other Study ID Numbers: 160105
First Posted: February 8, 2017    Key Record Dates
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided