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Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

Not Applicable
Completed
Conditions
Rotator Cuff Injury
Interventions
Procedure: LASER CO2
Procedure: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Laser CO2LASER CO2-
TENSTENS-
Primary Outcome Measures
NameTimeMethod
Visual Analogue Scale Mean ScoreChange 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
NameTimeMethod
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 AssessmentChange 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

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