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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00623909
First received: February 14, 2008
Last updated: June 13, 2013
Last verified: June 2013

February 14, 2008
June 13, 2013
January 2008
December 2008   (final data collection date for primary outcome measure)
The McGill pain questionnaire [ Time Frame: 6 Treatments/6 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623909 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study
Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study.

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Laser Therapy
  • Post Thoracotomy Pain
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.
Experimental: 1
To demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects
Intervention: Device: AvicennaTM class IV laser application
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623909
0709009417
No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Edward Rubin, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP