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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Pain||Procedure: Acupuncture and Questionnaires Procedure: Placebo Acupuncture, Questionnaires||Phase 3|
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.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture for Post-Thoracotomy Pain: A Randomized Controlled Trial|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
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.
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
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
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142532
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Barrie Cassileth, PhD||Memorial Sloan Kettering Cancer Center|