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Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

This study is currently recruiting participants.
Verified August 2012 by Istituto Ortopedico Rizzoli
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01391000
First received: June 15, 2011
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  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 Phase
Rotator Cuff Injury
 Procedure: LASER CO2
Procedure: TENS
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]
    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.


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) ] [ Designated as safety issue: No ]
  • Short Form 12 for quality of life assessment [ Time Frame: Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 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 miconsec, 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391000

Contacts
Contact: Roberta monesi, pt 00390516366694 cristiana.forni@ior.it

Locations
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Bo, Italy, 40136
Contact: Roberta Monesi, pt     00390516366694     cristiana.forni@ior.it    
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Roberta Monesi, PT Istituto Ortopedico Rizzoli
  More Information

No publications provided

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01391000     History of Changes
Other Study ID Numbers: 0013483
Study First Received: June 15, 2011
Last Updated: August 21, 2012
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013