An interventional study of LASER CO2 and TENS in Rotator Cuff Injury, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff.
To evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff and to evaluate, at the end of the rehabilitation period, the range of motion, the function gained and the quality of life comparatively in the two groups of patients treated with Transcutaneous Electrical Stimulation or Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: LASER CO2
Procedure: TENS
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
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
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.
Time frame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
Constant Murley Score for Range of Motion and Shoulder Function Assessment.
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.
Time frame: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)
Short Form 12-PCS for Quality of Life Assessment
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.
Time frame: Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)
| Milestone | Laser CO2 | TENS |
|---|---|---|
| Started | 35 | 35 |
| Completed | 33 | 35 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
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.
| units on a scale | Laser CO2 | TENS |
|---|---|---|
| Visual Analogue Scale Mean Score | 1.40 (0.96 to 1.84) | 1.20 (0.73 to 1.73) |
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.
| units on a scale | Laser CO2 | TENS |
|---|---|---|
| Constant Murley Score for Range of Motion and Shoulder Function Assessment. | 42.12 (36.79 to 47.45) | 41.69 (36.34 to 47.04) |
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.
| units on a scale | Laser CO2 | TENS |
|---|---|---|
| Short Form 12-PCS for Quality of Life Assessment | 41.07 (38.05 to 44.09) | 41.35 (38.22 to 44.47) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laser CO2 | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| TENS | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Continuous(years) | Laser CO2 | TENS | Total |
|---|---|---|---|
| Mean | 58 ± 9.2 | 61.6 ± 6.5 | 59.8 ± 7.8 |
| Sex: Female, Male(Participants) | Laser CO2 | TENS | Total |
|---|---|---|---|
| Female | 13 | 14 | 27 |
| Male | 20 | 21 | 41 |
| Number of participants with Traumatic Lesion(Participants) | Laser CO2 | TENS | Total |
|---|---|---|---|
| Count of participants | 18 | 12 | 30 |
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istituto Ortopedico Rizzoli