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WithdrawnNCT00623909Updated Feb 7, 2017

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

An interventional study of AvicennaTM class IV laser application in Laser Therapy and Post Thoracotomy Pain, sponsored by Weill Medical College of Cornell University. Withdrawn at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Principal Investigator left the institution
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

This study was terminated prior to enrollment and closed.

02

Conditions studied

  • Laser Therapy
  • Post Thoracotomy Pain

Keywords

  • Laser Therapy
  • Post Thoracotomy Pain
  • AvicennaTM laser
03

In context

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DeviceAvicennaTM 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.

06

What researchers measure

Primary outcomes

  1. The McGill pain questionnaire

    Time frame: 6 Treatments/6 Weeks

Secondary outcomes

  1. The visual analog scale

    Time frame: 6 Weeks

  2. An infrared thermometer will measure skin temperature before and after the treatment

    Time frame: 6 Treatments/6 Weeks

  3. A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness.

    Time frame: 6 Treatments/6 Weeks

  4. A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness

    Time frame: 6 Treatments/6 Weeks

  5. 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

07

Study locations

1 site
  • Weill Cornell Medical College/New York Presbyterian Hospital
    New York, New York 10065, United States
08

References and documents

Individual participant data

Plan to share: No — Not Applicable, study terminated prior to enrollment and closed

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00623909
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Feb 26, 2008
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Feb 7, 2017

Study contacts

Edward Rubin, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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