Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty

November 6, 2017 updated by: Hospital de Clinicas de Porto Alegre

Acute Effects of Transcutaneous Electrical Nerve Stimulation in Patients Rehabilitation After Total Hip Arthroplasty

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 45 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 45 minutes
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 160105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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