Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
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|ClinicalTrials.gov Identifier: NCT01391000|
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : August 2, 2017
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Injury||Procedure: LASER CO2 Procedure: TENS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Light Amplification by Simulated Emission Radiation Carbon Dioxide (Laser CO2) Versus Transcutaneous Electrical Stimulation (TENS) for the Reduction of Pain in Patients After Reconstruction of the Rotator Cuff. A Randomized Controlled Trial|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||November 2013|
|Experimental: Laser CO2||
Procedure: 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
|Active Comparator: 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 [ Time Frame: 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.
- Constant Murley Score for Range of Motion and Shoulder Function Assessment. [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391000
|Istituto Ortopedico Rizzoli|
|Bologna, Bo, Italy, 40136|
|Principal Investigator:||Roberta Monesi, PT||Istituto Ortopedico Rizzoli|