Pain, Transcutaneous Electric Nerve Stimulation
Conditions
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.
Interventions
DEVICETranscutaneous 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.
OTHERExercises
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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Participant flow
Recruitment details
The study was carried out at the Hospital de Clínicas de Porto Alegre Hospital (HCPA), Rio Grande do Sul, Brazil. Evaluations and interventions occurred between May and August 2016.
Participants by arm
| Arm | Count |
|---|---|
| Electrical Stimulation This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises). | 15 |
| Physical Therapy This group received only conventional physical therapy (exercises). | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Electrical Stimulation | Physical Therapy | Total |
|---|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 9.9 | 66.9 years STANDARD_DEVIATION 12.8 | 63.3 years STANDARD_DEVIATION 11.8 |
| Body mass index (BMI) | 29.5 kg/m² STANDARD_DEVIATION 3.4 | 28.6 kg/m² STANDARD_DEVIATION 5.9 | 29.06 kg/m² STANDARD_DEVIATION 4.8 |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Pain Level From Baseline to 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.
Time frame: baseline, 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrical Stimulation | Change in Pain Level From Baseline to 45 Minutes | 1.2 units on a scale | Standard Deviation 1.9 |
| Physical Therapy | Change in Pain Level From Baseline to 45 Minutes | 3.7 units on a scale | Standard Deviation 2.6 |
Secondary
Change in Hip Range of Motion From Baseline to 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.
Time frame: baseline, 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrical Stimulation | Change in Hip Range of Motion From Baseline to 45 Minutes | 22.5 degrees | Standard Deviation 5.8 |
| Physical Therapy | Change in Hip Range of Motion From Baseline to 45 Minutes | 20.5 degrees | Standard Deviation 4.3 |
Secondary
Number of Participants Who Received Morphine Within 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.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electrical Stimulation | Number of Participants Who Received Morphine Within 24 Hours | 6 participants |
| Physical Therapy | Number of Participants Who Received Morphine Within 24 Hours | 3 participants |