Rotator Cuff Injury
Conditions
Keywords
rotator cuff surgery, pain, exercise therapy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELASER 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
PROCEDURETENS
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.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* subjects after surgery for rotator cuff injury of traumatic and / or degenerative
Exclusion criteria
* concomitant fractures of the humerus, pace-maker, diseases for which treatments are contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Mean Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley Score for Range of Motion and Shoulder Function Assessment. | 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. |
| Short Form 12-PCS for Quality of Life Assessment | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| 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. | 35 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Laser CO2 | TENS | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 9.2 | 61.6 years STANDARD_DEVIATION 6.5 | 59.8 years STANDARD_DEVIATION 7.8 |
| Number of participants with Traumatic Lesion | 18 Participants | 12 Participants | 30 Participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 0 / 33 | 0 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Laser CO2 | Visual Analogue Scale Mean Score | 1.40 units on a scale |
| TENS | Visual Analogue Scale Mean Score | 1.20 units on a scale |
Secondary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Laser CO2 | Constant Murley Score for Range of Motion and Shoulder Function Assessment. | 42.12 units on a scale |
| TENS | Constant Murley Score for Range of Motion and Shoulder Function Assessment. | 41.69 units on a scale |
Secondary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Laser CO2 | Short Form 12-PCS for Quality of Life Assessment | 41.07 units on a scale |
| TENS | Short Form 12-PCS for Quality of Life Assessment | 41.35 units on a scale |