Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial

/Home/Chiropractic & Acupuncture/Acupuncture Research

Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial
Received: 21 November 2005
Accepted: 3 May 2006
Published: 3 May 2006
Andrew J Vickers1,2 , Valerie W Rusch3 , Vivek T Malhotra4 , Robert J Downey3 and Barrie R Cassileth1
BMC Anesthesiology 2006
BioMed Central

1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
2Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
3Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
4Department of Anesthesiology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA

Abstract

Background
Thoracotomy is associated with severe pain that may persist for years. Acupuncture is a complementary therapy with a proven role in pain control. A randomized trial showed that acupuncture was effective in controlling pain after abdominal surgery, but the efficacy of this technique for the treatment of thoracotomy pain has not been established. We developed a novel technique for convenient application of acupuncture to patients undergoing thoracotomy, and in a Phase II trial evaluated the safety of this intervention and the feasibility of doing a randomized trial.

Methods
Adult patients scheduled for unilateral thoracotomy with preoperative epidural catheter placement received acupuncture immediately prior to surgery. Eighteen semi-permanent intradermal needles were inserted on either side of the spine, and four were inserted in the legs and auricles. Needles were removed after four weeks. Using a numerical rating scale, pain was measured on the first five postoperative days. After discharge, pain was assessed using the Brief Pain Inventory at 7, 30, 60 and 90 days.

Results
Thirty-six patients were treated with acupuncture. Of these, 25, 23, and 22 patients provided data at 30, 60, and 90 days, respectively. The intervention was well tolerated by patients with only one minor and transient adverse event of skin ulceration.

Conclusion
The rate of data completion met our predefined criterion for determining a randomized trial to be feasible (at least 75% of patients tolerated the intervention and provided evaluable data). This novel intervention is acceptable to patients undergoing thoracotomy and does not interfere with standard preoperative care. There was no evidence of important adverse events. We are now testing the hypothesis that acupuncture significantly adds to standard perioperative pain management in a randomized trial.

Background
Thoracotomy is a common procedure employed for primary lung cancer, with almost 30,000 performed annually in the United States (Source: Agency for Healthcare Research and Quality). The procedure is extensive and can be associated with severe pain in patients already compromised by numerous other co-morbidities such as chronic obstructive pulmonary disease. Pain that limits respiratory function can have devastating consequences on post-operative recovery; consequently, extensive measures such as epidural catheters, local anesthetic infiltration and nonsteroidal-anti-inflammatory drugs (NSAIDs), are used to maximize analgesia and minimize side effects. [1,2]. Acupuncture represents a modality providing analgesia with a paucity of side effects; however, acupuncture needles can potentially overlap with the surgical field and also hamper epidural catheter placement, making acupuncture impractical. We undertook a single-arm, open-label, clinical trial to assess: 1) the feasibility of employing pre-operative acupuncture needles near the operative field for analgesia after thoracotomy, 2) the acceptance by patient's of a non-traditional technique after receiving a diagnosis as ominous as cancer, 3) the percentage of patients providing evaluable pain data at the first post-operative visit (approximately 30 days post surgery), 4) the occurrence of any adverse effects, 5) to determine the optimal primary outcome and timepoint for the randomized trial, 6) to provide data to determine sample size calculations. With respect to the primary aim, the trial was considered "feasible" if at least 75% of patients tolerated the intervention; if the intervention did not interfere with surgery and routine post-operative care; if at least 75% of patients provided evaluable data at the first post-operative visit; and, if reported adverse events were acceptable. Furthermore, accrual needed to be sufficiently rapid so that, after appropriate sample size calculations, a randomized trial could be completed in less than two years.

© 2006 Vickers et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Complete article may be viewed online.