Transcutaneous Electric Nerve StimulationNCT03046212
Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty
A study testing Transcutaneous electrical nerve stimulation and Exercises in people with Transcutaneous Electric Nerve Stimulation and Pain, run by Hospital de Clinicas de Porto Alegre.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Transcutaneous Electric Nerve Stimulation, Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation and Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who underwent THA surgery due to primary or secondary coxarthrosis; both sexes; age between 40 and 90 years.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Transcutaneous Electric Nerve Stimulation, Pain
- Being tested
- Transcutaneous electrical nerve stimulation, Exercises
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Also called TENS
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.
ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises). Receives: Device: Transcutaneous electrical nerve stimulation; Other: Exercises |
| Physical therapy | Active comparator | This group received only conventional physical therapy (exercises). Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 45 minutes
Secondary outcomes (2)
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.
Measured: baseline, 45 minutes
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transcutaneous Electric Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046212
- Sponsor's protocol ID
- 160105
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2016
- Last updated
- 9 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Transcutaneous Electrical Nerve Stimulation in Patients Rehabilitation After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03046212
- Acronym / sponsor ID
- 160105
- Conditions
- Transcutaneous Electric Nerve Stimulation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 9 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Device: Transcutaneous electrical nerve stimulation, Other: ExercisesThis group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises). |
| Physical therapy | Active comparator | Other: ExercisesThis group received only conventional physical therapy (exercises). |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent THA surgery due to primary or secondary coxarthrosis; both sexes; age between 40 and 90 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulationAlso: TENSTENS: 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. | Device | Electrical stimulation |
| ExercisesActive 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. | Other | Electrical stimulation, Physical therapy |
Primary outcome
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.
2 secondary outcomes
Change in Hip Range of Motion From Baseline to 45 Minutes
Time frame: baseline, 45 minutes
Number of Participants Who Received Morphine Within 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation and Exercises in people with Transcutaneous Electric Nerve Stimulation and Pain, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level From Baseline to 45 Minutes (time frame: baseline, 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.