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Acupuncture for Post-Thoracotomy Pain

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ClinicalTrials.gov Identifier: NCT00142532
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 14, 2009
Sponsor:
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date January 14, 2009
Study Start Date  ICMJE June 2005
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
  • To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use [ Time Frame: one year ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • - 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 and 90 days later
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Post-Thoracotomy Pain
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Pain
Intervention  ICMJE
  • Procedure: Acupuncture and Questionnaires

    Acupuncture 30 day treatment BL12 - 19 and extra point Wei Guan Xia Shu Each side of the spine,1.5 cun (~2.5cm) lateral to the lower border of spinous process of the T2 - 10 spinal vertebrae respectively 4 weeks ST36, Below the knee, 3 cun (~7.5cm) inferior to the lower border of the patella, one finger breadth lateral to the anterior crest of the tibia. One week following removal of epidural.

    Shenmen, bilaterally. At the lateral 1/3 of the triangular fossa in the auricle.One week following removal of epidural.

    Questionnaires 30 / 60 / 90 Day and 12 Month Follow-up-Numerical rating scale of pain; total opioid use; Medication Quantification Scale; length of stay; Brief Pain Inventory

  • Procedure: Placebo Acupuncture, Questionnaires

    The back studs will be placed halfway between the upper and lower border of spinous processes T2 to T10, approximately 0.5 cun (~1.25cm) from the spine. The leg studs will be placed at 2 cun (~5cm) posterior to GB34 on the posterior of the lower leg. No studs will be placed in the ear; rather studs will be placed on the anterior arm, 3 cun (~ 5cm) proximal and 3 cun (~ 5cm) medial to the midpoint of the antecubital crease.

    Pain will be assessed by a 0 - 10 point numerical rating scale (NRS) marked "no pain" at one end and "worst pain" at the other.

Study Arms  ICMJE
  • Experimental: 1
    At the time of pre-op preparation, 18 semi-permanent intradermal acupuncture studs will be placed at acupuncture points in the back, two will be placed in the legs and two in the ear. All studs will be replaced when the epidural is removed or, for patients without epidurals, shortly before discharge. The new leg and auricular studs will then be removed at eleven days; the new back studs will be removed at the three week post-discharge consult.
    Intervention: Procedure: Acupuncture and Questionnaires
  • Placebo Comparator: 2

    The treatment is the same as for the true acupuncture group, with the following exceptions. The studs in the back will be dummy studs have no needle and that have been used in previous research at MSKCC. The back studs will be placed halfway between the upper and lower border of spinous processes T2 to T10, approximately 0.5 cun (~1.25cm) from the spine. The leg studs will be placed at 2 cun (~5cm) posterior to GB34 on the posterior of the lower leg. No studs will be placed in the ear; rather studs will be placed on the anterior arm, 3 cun (~ 5cm) proximal and 3 cun (~ 5cm) medial to the midpoint of the antecubital crease.

    Numerical rating scale of pain; total opioid use; Medication Quantification Scale; length of stay; Brief Pain Inventory

    Intervention: Procedure: Placebo Acupuncture, Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2009)
162
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
146
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142532
Other Study ID Numbers  ICMJE 04-073
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barrie Cassileth, PhD, Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barrie Cassileth, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP