Trial Outcomes & Findings for Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff (NCT NCT01391000)
NCT ID: NCT01391000
Last Updated: 2018-02-13
Results Overview
To evaluate the analgesic efficacy of Light Amplification by Stimulated Emission of Radiation carbon dioxide therapy vs Transcutaneous Electrical Nerve Stimulator during the first cycle of rehabilitation through Visual Analogue Scale, calculating the mean score in values of beginning and end of daily treatment. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.
COMPLETED
NA
70 participants
Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
2018-02-13
Participant Flow
Participant milestones
| Measure |
Laser CO2
LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
|
TENS
TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Laser CO2
LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
|
TENS
TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
Baseline characteristics by cohort
| Measure |
Laser CO2
n=33 Participants
LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
|
TENS
n=35 Participants
TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
61.6 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 7.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Number of participants with Traumatic Lesion
|
18 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)To evaluate the analgesic efficacy of Light Amplification by Stimulated Emission of Radiation carbon dioxide therapy vs Transcutaneous Electrical Nerve Stimulator during the first cycle of rehabilitation through Visual Analogue Scale, calculating the mean score in values of beginning and end of daily treatment. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.
Outcome measures
| Measure |
Laser CO2
n=33 Participants
LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
|
TENS
n=35 Participants
TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
|
|---|---|---|
|
Visual Analogue Scale Mean Score
|
1.40 units on a scale
Interval 0.96 to 1.84
|
1.20 units on a scale
Interval 0.73 to 1.73
|
SECONDARY outcome
Timeframe: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)The Constant Murley scale had values from 0 to 100 where zero represented the worst possible range of motion and shoulder function and 100 the best.
Outcome measures
| Measure |
Laser CO2
n=33 Participants
LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
|
TENS
n=35 Participants
TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
|
|---|---|---|
|
Constant Murley Score for Range of Motion and Shoulder Function Assessment.
|
42.12 units on a scale
Interval 36.79 to 47.45
|
41.69 units on a scale
Interval 36.34 to 47.04
|
SECONDARY outcome
Timeframe: Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. SF-12 score measures substantially limited physical disability, general well-being and the perception of one's state of health, (Physical Component Summary) and also measure the psychological attitude of the patient, the limitation in social and personal activities (Mental Component Summary). Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Laser CO2
n=33 Participants
LASER CO2: The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
|
TENS
n=35 Participants
TENS: Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA.
|
|---|---|---|
|
Short Form 12-PCS for Quality of Life Assessment
|
41.07 units on a scale
Interval 38.05 to 44.09
|
41.35 units on a scale
Interval 38.22 to 44.47
|
Adverse Events
Laser CO2
TENS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place