Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation After Total Knee Arthroplasty. (NCT NCT03046225)
NCT ID: NCT03046225
Last Updated: 2018-03-22
Results Overview
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.
COMPLETED
NA
26 participants
90 minutes
2018-03-22
Participant Flow
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 September 2016.
Participant milestones
| Measure |
Electrical Stimulation
This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
|
Physical Therapy
This group received only conventional physical therapy (continuous passive movement device and exercises).
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcutaneous Electrical Nerve Stimulation After Total Knee Arthroplasty.
Baseline characteristics by cohort
| Measure |
Electrical Stimulation
n=13 Participants
This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
|
Physical Therapy
n=13 Participants
This group received only conventional physical therapy (continuous passive movement device and exercises).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 Years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
66.5 Years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
67.1 Years
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
30.7 kg/m²
STANDARD_DEVIATION 3.7 • n=99 Participants
|
32 kg/m²
STANDARD_DEVIATION 4.3 • n=107 Participants
|
31.3 kg/m²
STANDARD_DEVIATION 4 • n=206 Participants
|
|
Femoral nerve block
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 minutesIt 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.
Outcome measures
| Measure |
Electrical Stimulation
n=13 Participants
This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
|
Physical Therapy
n=13 Participants
This group received only conventional physical therapy (continuous passive movement device and exercises).
|
|---|---|---|
|
Change in Pain Level From Baseline to 90 Minutes
|
3.1 Units on a scale
Standard Deviation 2.6
|
3.3 Units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 24 hoursIt 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.
Outcome measures
| Measure |
Electrical Stimulation
n=13 Participants
This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
|
Physical Therapy
n=13 Participants
This group received only conventional physical therapy (continuous passive movement device and exercises).
|
|---|---|---|
|
Number of Participants Who Received Morphine Within 24 Hours
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 minutesIt 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.
Outcome measures
| Measure |
Electrical Stimulation
n=13 Participants
This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).
|
Physical Therapy
n=13 Participants
This group received only conventional physical therapy (continuous passive movement device and exercises).
|
|---|---|---|
|
Change in Knee Range of Motion From Baseline to 30 Minutes
|
46.2 Degrees
Standard Deviation 10.4
|
44.9 Degrees
Standard Deviation 6.2
|
Adverse Events
Electrical Stimulation
Physical Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Graciele Sbruzzi
Hospital de Clínicas de Porto Alegre
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place