Acupuncture for Post-Thoracotomy Pain

Pain Clinical Trial

Official title:

Acupuncture for Post-Thoracotomy Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142532
• Other study ID #: 04-073
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: January 13, 2009
• Start date: June 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Pain

Intervention

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 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use		one year	No
Primary	To determine whether acupuncture affects the immediate post-operative period and/or 30, 60, 90 days and approximately 12 months later		one year	No

External Links

•   Memorial Sloan-Kettering Cancer Center