Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study

Not Applicable

Withdrawn

• Conditions: Laser Therapy; Post Thoracotomy Pain
• Interventions: Device: AvicennaTM class IV laser application

• Registration Number: NCT00623909
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this study is to demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects. In addition, we seek to measure the effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy pain syndrome.

Detailed Description

This study was terminated prior to enrollment and closed.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-26
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Men and women age 25-65 years old with chest wall pain after lung surgery lasting more than 2 months after surgery.
• Subjects shall have failed conservative treatment which may include rest, physical therapy, braces, and over the counter anti-inflammatory medications. All those enrolled will be native English speakers and have at least a high school degree

Exclusion Criteria

• Subjects will be excluded if they are pregnant (which will be confirmed by a urine pregnancy test if they are of childbearing age)
• Have previous history of other pain syndromes or psychiatric disorders.
• We will exclude the morbidly obese (BMI >30) because the laser may not be able to penetrate deep enough through adipose tissue. In addition, subjects who have had previous back surgery, or are on antidepressants for the treatment of depression in the preceding 6 weeks will be excluded as these may represent potential confounding factors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AvicennaTM class IV laser application	To demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects. This study was terminated prior to subject enrollment and closed.

Primary Outcome Measures

Name	Time	Method
The McGill pain questionnaire	6 Treatments/6 Weeks

Secondary Outcome Measures

Name	Time	Method
The visual analog scale	6 Weeks
An infrared thermometer will measure skin temperature before and after the treatment	6 Treatments/6 Weeks
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness.	6 Treatments/6 Weeks
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness	6 Treatments/6 Weeks
At the end of the study patients will rate their satisfaction with the treatment using an 11 point Likert scale where 0 means completely dissatisfied and 10 means completely satisfied.	6 Treatments/6 Weeks

Trial Locations

Locations (1)

Weill Cornell Medical College/New York Presbyterian Hospital; 🇺🇸 New York, New York, United States