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

NCT00623909 | Withdrawn

• 1 other identifier: 0709009417
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laser Therapy; Post Thoracotomy Pain

Keywords

Laser Therapy; Post Thoracotomy Pain; AvicennaTM laser

Outcome Measures

Primary Outcomes (1)

• The McGill pain questionnaire

  6 Treatments/6 Weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

AvicennaTM class IV laser application DEVICE

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.

1

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Study Officials

• Edward Rubin, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable, study terminated prior to enrollment and closed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 26, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)