Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00623909

Purpose

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.

Condition	Intervention
Laser Therapy Post Thoracotomy Pain	Device: AvicennaTM class IV laser application

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study.

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

The McGill pain questionnaire [ Time Frame: 6 Treatments/6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The visual analog scale [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
An infrared thermometer will measure skin temperature before and after the treatment [ Time Frame: 6 Treatments/6 Weeks ] [ Designated as safety issue: Yes ]
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness. [ Time Frame: 6 Treatments/6 Weeks ] [ Designated as safety issue: Yes ]
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness [ Time Frame: 6 Treatments/6 Weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 6 Treatments/6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental To demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects	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.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623909

Contacts

Contact: Edward Rubin, MD	(212) 746-4673	edr9009@med.cornell.edu
Contact: Rachel Brody, RN	(212) 746-2774	rab9027@med.cornell.edu

Locations

United States, New York
Weill Cornell Medical College/New York Presbyterian Hospital	Recruiting
New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Edward Rubin, MD

Weill Cornell Medical College

More Information

No publications provided

Responsible Party:	Weill Cornell Medical College ( Edward Rubin, MD )
Study ID Numbers:	0709009417
Study First Received:	February 14, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623909 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Laser Therapy
Post Thoracotomy Pain
AvicennaTM laser

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 03, 2009