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Acupuncture for Post-Thoracotomy Pain

This study is ongoing, but not recruiting participants.
Information provided by Memorial Sloan-Kettering Cancer Center

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Descriptive Information Fields
Brief Title  Acupuncture for Post-Thoracotomy Pain
Official Title  Acupuncture for Post-Thoracotomy Pain: A Randomized Controlled Trial
Brief Summary

Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in the early post-operative period after abdominal surgery, suggesting that acupuncture may have a role in preventing chronic post-thoracotomy pain. This study is being done in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.

Detailed Description

Rationale:

Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent years, researchers have come to understand how acupuncture might work in terms of nerve stimulation and the release of chemical messages in the body. Researchers have found evidence that acupuncture is useful in treating a variety of conditions, including headache, nausea, and pain after surgery.

Pain is a common problem after surgery for lung cancer. Many patients experience pain in the first few days after surgery, despite medication. In some patients, this pain can last for many months or years afterwards.

Purpose:

A pilot study of acupuncture in patients undergoing lung cancer surgery was conducted previously and found that this study was feasible to implement and well-received by patients. We now wish to conduct a larger study in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.

  • To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use
  • To determine whether acupuncture affects the immediate post-operative period and/or 30, 60,90 days and approximately 12 months later.
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use [ Time Frame: one year ] [ Designated as safety issue: No ]
To determine whether acupuncture affects the immediate post-operative period and/or 30, 60, 90 days and approximately 12 months later [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Lung Cancer
Pain
Intervention  Procedure: Acupuncture and Questionnaires
Procedure: Placebo Acupuncture, Questionnaires
MEDLINE PMIDs
Links Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  146
Start Date  June 2005
Completion Date June 2009
Eligibility Criteria 

Inclusion Criteria:

  • Patients undergoing unilateral thoracotomy at Memorial Sloan-Kettering Cancer Center (MSKCC)
  • Age greater than or equal to 18 years old.

Exclusion Criteria:

  • Any of the following procedures: hemiclamshell, clamshell, extrapleural approach, chest wall involvement, esophagectomy. These more extensive procedures have a higher risk of complications.
  • Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture
  • Platelets < 20,000 or International Normalized Ratio (INR) > 2.5 or absolute neutrophil count (ANC) < 0.5; though it would be unusual for any patient to be operated on with such values, it seems wise as a precautionary measure to avoid risk of bleeding from acupuncture.
  • Known cardiac conditions constituting a high or moderate risk of endocarditis as defined by the American Heart Association criteria
  • Patients unable to remove studs without assistance, who have no home assistance, and who are unable or unwilling to return to the hospital in the event that they decide to remove studs before the post-discharge visit.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00142532
Organization ID 04-073
Secondary IDs ††
Study Sponsor  Memorial Sloan-Kettering Cancer Center
Collaborators ††
Investigators 
Principal Investigator:     Barrie Cassileth, PhD     Memorial Sloan-Kettering Cancer Center    
Information Provided By Memorial Sloan-Kettering Cancer Center
Verification Date December 2007
First Received Date  August 31, 2005
Last Updated Date December 10, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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