Laser Therapy, Post Thoracotomy Pain
Conditions
Keywords
Laser Therapy, Post Thoracotomy Pain, AvicennaTM laser
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.
Interventions
DEVICEAvicennaTM class IV laser application
AvicennaTM class IV laser for application over the skin of human subjects in the treatment of post-thoracotomy pain syndrome. Six sessions, twenty minutes applications over a period of six weeks.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Not applicable, study terminated prior to enrollment and closed.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The McGill pain questionnaire | 6 Treatments/6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed