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Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01391000
First Posted: July 11, 2011
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
  Purpose
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.

Condition Intervention
Rotator Cuff Injury Procedure: LASER CO2 Procedure: TENS

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

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:
  • Visual Analogue Scale Mean Score [ Time Frame: 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:
  • Constant Murley Score for Range of Motion and Shoulder Function Assessment. [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 70
Study Start Date: July 2011
Study Completion Date: November 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser CO2 Procedure: LASER CO2
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
Active Comparator: TENS Procedure: TENS

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.


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391000


Locations
Italy
Istituto Ortopedico Rizzoli
Bologna, Bo, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Roberta Monesi, PT Istituto Ortopedico Rizzoli
  More Information

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01391000     History of Changes
Other Study ID Numbers: 0013483
First Submitted: June 15, 2011
First Posted: July 11, 2011
Results First Submitted: February 3, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017
Last Verified: April 2017

Keywords provided by Istituto Ortopedico Rizzoli:
rotator cuff surgery
pain
exercise therapy

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries