Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rotator Cuff Injury

Intervention / Treatment
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* Procedure: LASER CO2
* Procedure: TENS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser CO2<br> | Procedure: LASER CO2<br>* 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<br>|
| Active Comparator: TENS<br> | Procedure: TENS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline in pain at the end of the rehabilitation cycle (two weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff surgery, pain, exercise therapy