Back to resultsLaser CO2 Versus TENS After Reconstruction of the Rotator Cuff
Primary Purpose
Rotator Cuff Injury
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LASER CO2
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injury focused on measuring rotator cuff surgery, pain, exercise therapy
Eligibility Criteria
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.
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser CO2
TENS
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01391000
First Posted
June 15, 2011
Last Updated
January 16, 2018
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT01391000
Brief Title
Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
Keywords
rotator cuff surgery, pain, exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser CO2
Arm Type
Experimental
Arm Title
TENS
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
LASER CO2
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale Mean Score
Description
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 Outcome Measure Information:
Title
Constant Murley Score for Range of Motion and Shoulder Function Assessment.
Description
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)
Title
Short Form 12-PCS for Quality of Life Assessment
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta Monesi, PT
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
State/Province
Bo
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
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Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
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