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

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Post Thoracotomy Pain; Laser Therapy

Treatments: Device: AvicennaTM class IV laser application

Study type: Interventional

Funder types: Other

Identifiers

NCT00623909

0709009417

Details and patient eligibility

About

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.

Full description

This study was terminated prior to enrollment and closed.

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Device: AvicennaTM class IV laser application