Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
- Conditions
- Rotator Cuff Injury
- Interventions
- Procedure: LASER CO2Procedure: TENS
- Registration Number
- NCT01391000
- Lead Sponsor
- Istituto Ortopedico Rizzoli
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- subjects after surgery for rotator cuff injury of traumatic and / or degenerative
- concomitant fractures of the humerus, pace-maker, diseases for which treatments are contraindicated.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laser CO2 LASER CO2 - TENS TENS -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Bo, Italy