Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff

NCT01391000 | Completed Results

• 1 other identifier: 0013483
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injury

Keywords

rotator cuff surgery; pain; exercise therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Short Form 12-PCS for Quality of Life Assessment

  Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)

Study Arms (2)

Laser CO2

EXPERIMENTAL

Procedure: LASER CO2

TENS

ACTIVE COMPARATOR

Procedure: TENS

Interventions

LASER CO2 PROCEDURE

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

Laser CO2

TENS PROCEDURE

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.

TENS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects after surgery for rotator cuff injury of traumatic and / or degenerative

You may not qualify if:

• concomitant fractures of the humerus, pace-maker, diseases for which treatments are contraindicated.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bo, 40136, Italy

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Interventions

Lasers, Gas; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr Roberta Monesi
• Organization: Istituto Ortopedico Rizzoli

cristiana.forni@ior.it

0516366694

Study Officials

• Roberta Monesi, PT

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: July 11, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 13, 2018
• Results First Posted: August 2, 2017

Record last verified: 2018-01

Locations

IT (1)