Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| 2 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and Questionnaires | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use | one year | |
| To determine whether acupuncture affects the immediate post-operative period and/or 30, 60, 90 days and approximately 12 months later | one year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barrie Cassileth, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Acupuncture, Questionnaires | Procedure | 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. |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 |
| Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |