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

Study Overview
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Brief Summary
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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
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This study was terminated prior to enrollment and closed.

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

Conditions
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Laser Therapy, Post Thoracotomy Pain

Intervention / Treatment
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* Device: AvicennaTM class IV laser application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Device: AvicennaTM class IV laser application<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The McGill pain questionnaire |  | 6 Treatments/6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Therapy, Post Thoracotomy Pain, AvicennaTM laser