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

Laser Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00623909
• Other study ID #: 0709009417
• Status: Withdrawn
• Phase: N/A
• First received: February 14, 2008
• Last updated: February 3, 2017
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was terminated prior to enrollment and closed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laser Therapy
• Post Thoracotomy Pain

Intervention

Device:
• AvicennaTM 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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College/New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The McGill pain questionnaire		6 Treatments/6 Weeks
Secondary	The visual analog scale		6 Weeks
Secondary	An infrared thermometer will measure skin temperature before and after the treatment		6 Treatments/6 Weeks
Secondary	A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness.		6 Treatments/6 Weeks
Secondary	A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness		6 Treatments/6 Weeks
Secondary	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