The American Academy of Pain Medicine      Annual Meeting Home Page     
23rd Annual Meeting
February 7-10, 2007
New Orleans, LA

© 2006 American Academy of Pain Medicine
 


Thursday, February 8, 2007
113

Evaluation of the Safety and Efficacy of Lidoderm® (Lidocaine Patch 5%) Compared to Trigger Point Injections (1% Lidocaine) in Patients with Low Back Pain after Non-operated Injury: A Prospective, Randomized, Controlled Study

Michael G. Jenson, MS, PA-C, CPP1, Raymond F. Sorensen, DO1, Suna Barlas, PhD2, and Arnold R. Gammaitoni, PharmD2. (1) PETC Research Group, Inc., Tulsa, OK, USA, (2) Endo Pharmaceuticals, Inc., Chadds Ford, PA, USA

Introduction: Myofascial Pain Syndrome is a chronic muscle pain disorder associated with focal trigger points. The objective of this study was to evaluate the safety and efficacy of the lidocaine patch 5% (Patch) compared to trigger point injections (TPIs) using lidocaine 0.1% in patients with continued low back pain after injury without surgical intervention. Materials and Methods: Prospective, randomized, controlled study. Study protocol was approved by a local IRB, informed consent obtained prior to study start. A total of 40 patients (18-80 years of age) with clinical diagnosis of lower back with or without gluteal pain after prior injury that is primarily due to a muscular process were randomized at baseline to receive either 4 to 6 injections or patches (applied every 24 hrs) at the trigger sites. Treatment effects on pain qualities were assessed with the VAS, Physician's and Patient's Global Assessments of Response to Treatment, the McGill Short Form Pain Questionnaire, and algometer readings of the trigger points (in Kg) at Weeks 2 and 4. Results: Thirty-eight patients total completed the study; one TPI patient discontinued due to a 6-month absence and 1 Patch patient due to a rash. The Patch group reported significantly greater reductions in VAS (39 vs 16 mm), McGill (7 vs 3), and Ashworth (2.2 vs 0.8) scores compared to the TPI group in addition to marked improvement (5 vs 2.6) in algometer readings. Overall patient subjective response in terms of percent improvement was overwhelmingly in favor of Patch; 84% of Patch patients reported moderate or better pain relief compared to only 21% of TPI patients. Conclusion: The lidocaine patch 5% may be a potentially beneficial, noninvasive alternative therapy to TPI for myofascial pain.

References: Han SC, Harrison P. Myofascial pain syndrome and trigger-point management. Reg Anesth. 1997;22(1):89-101.

Saxen MA. Myofascial pain syndrome: characteristics, diagnosis, and treatment. J Indiana Dent Assoc. 1998;77(3):9-12.
Funding: This study was funded by Endo Pharmaceuticals, Inc.

Michael G. Jenson, MS, PA-C, CPP
Conflict of Interest Disclosure: Endo Pharmaceuticals, Inc., Researcher