Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Transcutaneous Electric Nerve Stimulation; Pain
• Interventions: Device: Transcutaneous electrical nerve stimulation; Other: Exercises

• Registration Number: NCT03046212
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Primary Completion: 2016-08
• Study Completion: 2016-11
• Study First Submitted: 2016-11-29
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-08
• Results First Submitted: 2017-03-09
• Results First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Results First Posted: 2017-11-09
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical stimulation	Exercises	This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
Electrical stimulation	Transcutaneous electrical nerve stimulation	This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).
Physical therapy	Exercises	This group received only conventional physical therapy (exercises).

Primary Outcome Measures

Name	Time	Method
Change in Pain Level From Baseline to 45 Minutes	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

Name	Time	Method
Number of Participants Who Received Morphine Within 24 Hours	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.
Change in Hip Range of Motion From Baseline to 45 Minutes	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.