Laser TherapyNCT00623909
Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study
A study testing AvicennaTM class IV laser application in people with Laser Therapy and Post Thoracotomy Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Laser Therapy, Post Thoracotomy Pain
- What is being tested?
- AvicennaTM class IV laser application
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065
About this study
Official title: 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.
Read the detailed description
This study was terminated prior to enrollment and closed.
- Conditions
- Laser Therapy, Post Thoracotomy Pain
- Being tested
- AvicennaTM class IV laser application
- Keywords
- Laser Therapy, Post Thoracotomy Pain, AvicennaTM laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvicennaTM class IV laser applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AvicennaTM class IV laser application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The McGill pain questionnaire
Measured: 6 Treatments/6 Weeks
Secondary outcomes (5)
The visual analog scale
Measured: 6 Weeks
An infrared thermometer will measure skin temperature before and after the treatment
Measured: 6 Treatments/6 Weeks
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness.
Measured: 6 Treatments/6 Weeks
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness
Measured: 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.
Measured: 6 Treatments/6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Principal Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser TherapyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Rubin, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623909
- Sponsor's protocol ID
- 0709009417
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2008
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not Applicable, study terminated prior to enrollment and closed
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study.
- ClinicalTrials.gov ID
- NCT00623909
- Acronym / sponsor ID
- 0709009417
- Conditions
- Laser Therapy, Post Thoracotomy Pain
- Keywords
- Laser Therapy, Post Thoracotomy Pain, AvicennaTM laser
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was terminated prior to enrollment and closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AvicennaTM class IV laser applicationTo 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvicennaTM class IV laser applicationAvicennaTM 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. | Device | 1 |
Primary outcome
The McGill pain questionnaire
Time frame: 6 Treatments/6 Weeks
5 secondary outcomes
The visual analog scale
Time frame: 6 Weeks
An infrared thermometer will measure skin temperature before and after the treatment
Time frame: 6 Treatments/6 Weeks
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness.
Time frame: 6 Treatments/6 Weeks
A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness
Time frame: 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.
Time frame: 6 Treatments/6 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No. Not Applicable, study terminated prior to enrollment and closed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Rubin, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AvicennaTM class IV laser application in people with Laser Therapy and Post Thoracotomy Pain, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The McGill pain questionnaire (time frame: 6 Treatments/6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.