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.

Study Overview

• Status: Withdrawn
• Conditions: Laser Therapy; Post Thoracotomy Pain
• Intervention / Treatment: Device: AvicennaTM class IV laser application

Detailed Description

This study was terminated prior to enrollment and closed.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Edward Rubin, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 26, 2008

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Laser Therapy; Post Thoracotomy Pain; AvicennaTM laser
• Other Study ID Numbers: 0709009417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not Applicable, study terminated prior to enrollment and closed