Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- visual analogue scale mean score [ Time Frame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks) ] [ Designated as safety issue: No ]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.
- 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) ] [ Designated as safety issue: No ]
- Short Form 12 for quality of life assessment [ Time Frame: Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Study Completion Date:||November 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391000
|Istituto Ortopedico Rizzoli|
|Bologna, Bo, Italy, 40136|
|Principal Investigator:||Roberta Monesi, PT||Istituto Ortopedico Rizzoli|