Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

Rotator Cuff Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391000
• Other study ID #: 0013483
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: January 16, 2018
• Start date: July 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2018
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Injury

Intervention

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
• 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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	Bo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
Secondary	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.	Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)
Secondary	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.	Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)