Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

Istituto Ortopedico Rizzoli70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rotator Cuff Injury

Interventions

LASER CO2PROCEDURE

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

TENSPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Bo, Italy

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

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)

Data from ClinicalTrials.gov

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