Transcutaneous Electric Nerve StimulationNCT03046225
Transcutaneous Electrical Nerve Stimulation After Total Knee Arthroplasty.
A study testing Transcutaneous electrical nerve stimulation, Continuous passive movement device and Exercises in people with Transcutaneous Electric Nerve Stimulation and Pain, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the postoperative period of TKA, the pain is intense and limits the mobility of patients, so the analgesia is one of the goals of the physical therapy. 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, Continuous passive movement device and Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 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 TKA surgery due to primary or secondary gonarthrosis; Both sexes; Age between 40 and 90 years.
Who cannot join
- Patients who refused to participate of the study; Indication of TKA for fractures and bone tumors; TKA review surgery; Infection during the postoperative period; Congenital anatomical alterations; Neurological disorders; Lack of understanding of commands; Sensitivity alterations in the lumbar spine or lower limbs; Decompensated heart disease or cardiac pacemaker use.
About this study
Official title: Acute Effects of Transcutaneous Electric Nerve Stimulation in Patients Rehabilitation After Total Knee Arthroplasty.
Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the postoperative period of TKA, the pain is intense and limits the mobility of patients, so the analgesia is one of the goals of the physical therapy. One of the alternatives available for pain management is the transcutaneous electrical nerve stimulation (TENS), characterized by the application of an electric pulsed current through electrodes positioned on the skin. Therefore, the present study aims to evaluate the acute effects of TENS associated with conventional physical therapy compared with conventional physical therapy on the pain level, knee range of motion and administration of morphine in the rehabilitation of patients after TKA.
Read the detailed description
The study included patients who underwent TKA 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 knee and the Administration of morphine.
The experimental group received TENS application held by two self-adhesive electrodes size 5x9cm positioned parallel to the lumbar spine, on the nerve roots L3, L4 and L5. 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, with the use of the CPM device and performing exercises. The CPM device was used for 30 minutes, and realized continuous passive flexion and extension of the operated knee. The amplitudes of these movements were gradually increased in accordance with the tolerance of the patient. The device used was Spectra model, by Kinetec.
Then, the patients realized active exercises of plantar flexion and dorsal flexion of the ankles and adduction and abduction of the hips, isometric exercises of flexion and extension of the operated knee and active exercises of flexion and extension of the non-operated knee. All exercises were performed in 10 repetitions, with the patient positioned in the supine position in the bed.
The control group received only conventional therapy consisting of the use of the CPM device in the operated leg and 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, Continuous passive movement device, 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 was applied in the conventional mode, through two self-adhesive electrodes of size 5x9cm positioned parallel to the lumbar spine, on the nerve roots of L3, L4 and L5, with frequency of 100 Hz and pulse duration of 100 μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was gradually increased, with his permission, during the application time.
Continuous passive movement deviceDevice
Also called CPM
CPM device was used for 30 minutes and realized continuous passive flexion and extension of the operated knee.
ExercisesOther
Active exercises of plantar flexion and dorsal flexion of the ankles, adduction and abduction of the hips and flexion and extension of the operated knees. All exercises were performed in 10 repetitions, with the patient positioned in the supine position in the bed.
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises). Receives: Device: Transcutaneous electrical nerve stimulation; Device: Continuous passive movement device; Other: Exercises |
| Physical therapy | Active comparator | This group received only conventional physical therapy (continuous passive movement device and exercises). Receives: Device: Continuous passive movement device; 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 90 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 of the pain level were performed in each group, before and after the interventions.
Measured: 90 minutes
Secondary outcomes (2)
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
Change in Knee Range of Motion From Baseline to 30 Minutes
It was extracted from the continuous passive movement device display. During the use of the continuous passive movement device (CPM), from the observation of the digital display in its control, the degrees of amplitude reached in the passive movements of flexion and extension of the knee submitted to the surgery were extracted.
Measured: 30 minutes
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 completionSep 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
- 26 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
- NCT03046225
- Sponsor's protocol ID
- 16-0104
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2016
- Last updated
- 22 Mar 2018
- 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 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Transcutaneous Electric Nerve Stimulation in Patients Rehabilitation After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT03046225
- Acronym / sponsor ID
- 16-0104
- Conditions
- Transcutaneous Electric Nerve Stimulation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 22 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the postoperative period of TKA, the pain is intense and limits the mobility of patients, so the analgesia is one of the goals of the physical therapy. One of the alternatives available for pain management is the transcutaneous electrical nerve stimulation (TENS), characterized by the application of an electric pulsed current through electrodes positioned on the skin. Therefore, the present study aims to evaluate the acute effects of TENS associated with conventional physical therapy compared with conventional physical therapy on the pain level, knee range of motion and administration of morphine in the rehabilitation of patients after TKA.
Detailed description
The study included patients who underwent TKA 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 knee and the Administration of morphine.
The experimental group received TENS application held by two self-adhesive electrodes size 5x9cm positioned parallel to the lumbar spine, on the nerve roots L3, L4 and L5. 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, with the use of the CPM device and performing exercises. The CPM device was used for 30 minutes, and realized continuous passive flexion and extension of the operated knee. The amplitudes of these movements were gradually increased in accordance with the tolerance of the patient. The device used was Spectra model, by Kinetec.
Then, the patients realized active exercises of plantar flexion and dorsal flexion of the ankles and adduction and abduction of the hips, isometric exercises of flexion and extension of the operated knee and active exercises of flexion and extension of the non-operated knee. All exercises were performed in 10 repetitions, with the patient positioned in the supine position in the bed.
The control group received only conventional therapy consisting of the use of the CPM device in the operated leg and 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, Device: Continuous passive movement device, Other: ExercisesThis group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises). |
| Physical therapy | Active comparator | Device: Continuous passive movement device, Other: ExercisesThis group received only conventional physical therapy (continuous passive movement device and 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 TKA surgery due to primary or secondary gonarthrosis; Both sexes; Age between 40 and 90 years.
Key exclusion criteria (1 listed)
- Patients who refused to participate of the study; Indication of TKA for fractures and bone tumors; TKA review surgery; Infection during the postoperative period; Congenital anatomical alterations; Neurological disorders; Lack of understanding of commands; Sensitivity alterations in the lumbar spine or 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 was applied in the conventional mode, through two self-adhesive electrodes of size 5x9cm positioned parallel to the lumbar spine, on the nerve roots of L3, L4 and L5, with frequency of 100 Hz and pulse duration of 100 μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was gradually increased, with his permission, during the application time. | Device | Electrical stimulation |
| Continuous passive movement deviceAlso: CPMCPM device was used for 30 minutes and realized continuous passive flexion and extension of the operated knee. | Device | Electrical stimulation, Physical therapy |
| ExercisesActive exercises of plantar flexion and dorsal flexion of the ankles, adduction and abduction of the hips and flexion and extension of the operated knees. All exercises were performed in 10 repetitions, with the patient positioned in the supine position in the bed. | Other | Electrical stimulation, Physical therapy |
Primary outcome
Change in Pain Level From Baseline to 90 Minutes
Time frame: 90 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 of the pain level were performed in each group, before and after the interventions.
2 secondary outcomes
Number of Participants Who Received Morphine Within 24 Hours
Time frame: 24 hours
Change in Knee Range of Motion From Baseline to 30 Minutes
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- 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, Continuous passive movement device 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 22 Mar 2018. 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 22 Mar 2018). 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 90 Minutes (time frame: 90 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 22 Mar 2018.