Cyclobenzaprine ER for muscle spasm associated with low back and neck pain: two randomized, double-blind, placebo-controlled studies of identical design

References

• Bosworth T. Special report: the proper use of muscle relaxants in musculoskeletal pain management. Primary Care 2002;6:1-8
   Google Scholar
• Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007;147:505-14
   PubMed Web of Science ®Google Scholar
• Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007;147:478-91
   PubMed Web of Science ®Google Scholar
• Borenstein DG, Korn S. Efficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trials. Clin Ther 2003;25:1056-73
   PubMed Web of Science ®Google Scholar
• Nibbelink DW, Strickland SC, McLean LF, et al. Cyclobenzaprine, diazepam and placebo in the treatment of skeletal muscle spasm of local origin. Clin Ther 1978;1:409-24
   Web of Science ®Google Scholar
• Brown BR Jr, Womble J. Cyclobenzaprine in intractable pain syndromes with muscle spasm. JAMA 1978;240:1151-2
   PubMed Web of Science ®Google Scholar
• Baratta RR. A double-blind study of cyclobenzaprine and placebo in the treatment of acute musculoskeletal conditions of the low back. Curr Ther Res Clin Exp 1982;32:646-52
   Web of Science ®Google Scholar
• Bercel NA. Cyclobenzaprine in the treatment of skeletal muscle spasm in osteoarthritis of the cervical and lumbar spine. Curr Ther Res 1977;22:462-8
   Web of Science ®Google Scholar
• Aiken DW. A comparative study of the effects of cyclobenzaprine, diazepam and placebo in the treatment of acute musculoskeletal conditions of the low back. Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications, 1978:34-8
   Google Scholar
• Bianchi M. Evaluation of cyclobenzaprine for skeletal muscle spasm of local origin. Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications, 1978:25-9
   Google Scholar
• Scheiner JJ. Cyclobenzaprine in the treatment of local muscle spasm. Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications, 1978:39-48
   Google Scholar
• Aiken DW. Cyclobenzaprine in the treatment of acute skeletal muscle spasm of local origin. Clinical Evaluation of Flexeril (Cyclobenzaprine HCl/MSD). Minneapolis, MN: Postgraduate Medicine Communications, 1978:30-3
   Google Scholar
• Steingard PM, Schilberg WL, Peterson KD. Multiclinic study of a muscle relaxant for treatment of acute musculoskeletal disorders. Osteopath Ann 1980;8:44-58
   Google Scholar
• van Tulder MW, Touray T, Furlan AD, et al. Muscle relaxants for non-specific low back pain. Cochrane Database Syst Rev 2003;Issue 4:CD004252
   PubMedGoogle Scholar
• Commissiong JW, Karoum F, Reiffenstein RJ, et al. Cyclobenzaprine: a possible mechanism of action for its muscle relaxant effect. Can J Physiol Pharmacol 1981;59:37-44
   PubMed Web of Science ®Google Scholar
• Katz WA, Dube J. Cyclobenzaprine in the treatment of acute muscle spasm: review of a decade of clinical experience. Clin Ther 1988;10:216-28
   PubMed Web of Science ®Google Scholar
• Nibbelink DW, Strickland SC. Cyclobenzaprine (Flexeril™): report of a postmarketing surveillance program. Curr Ther Res 1980;28:894-903
   Web of Science ®Google Scholar
• Malanga GA. The use of medications in the treatment of low back pain. In: Physical Medicine and Rehabilitation: State of the Art Reviews. Philadelphia, PA: Hanley and Belfus, Inc., 1999:13(3)
   Google Scholar
• Malanga G, Wolff E. Evidence-informed management of chronic low back pain with nonsteroidal anti-inflammatory drugs, muscle relaxants, and simple analgesics. Spine J 2008;8:173-84
   PubMed Web of Science ®Google Scholar
• Malanga GA, Roman S, Nadler SF. Medications in the treatment of whiplash associated disorders. In: Malanga GA, Nadler SF, eds. Whiplash. Philadelphia, PA: Hanley and Belfus, Inc., 2002:339-58
   Google Scholar
• Cyclobenzaprine hydrochloride tablets [package insert]. Corona, CA: Watson Laboratories, Inc., 2006
   Google Scholar
• Amrix [package insert]. Frazer, PA: Cephalon, Inc., 2007
   Google Scholar
• Darwish M, Hellriegel ET, Xie F. Single-dose pharmacokinetics of once-daily cyclobenzaprine extended release 30 mg versus cyclobenzaprine immediate release 10 mg three times daily in healthy young adults. A randomized, open-label, two-period crossover, single-centre study. Clin Drug Investig 2008;28:793-801
   PubMed Web of Science ®Google Scholar
• World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Available at: http://www.wma.net/e/policy/pdf/17c.pdf. [Last accessed 10 October 2008]
   Google Scholar
• International Conference on Harmonisation Working Group. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1). Presented at: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; June 10, 1996, Washington, DC
   Google Scholar
• Cyclobenzaprine HCl MR Investigator's Brochure. 2nd ed. Richmond, VA: ECR Pharmaceuticals, June 3, 2002
   Google Scholar
• Rollings HE, Glassman JM, Soyka JP. Management of acute musculoskeletal conditions. Thoracolumbar strain or sprain: a double-blind evaluation comparing the efficacy and safety of carisoprodol with cyclobenzaprine hydrochloride. Curr Ther Res 1983;34:917-28
   Web of Science ®Google Scholar
• McHorney CA, Ware JE Jr, Lu JF, et al. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994;32:40-66
   PubMed Web of Science ®Google Scholar
• Hodgkins M, Albert D, Daltroy L. Comparing patients’ and their physicians’ assessments of pain. Pain 1985;23:273-7
   PubMed Web of Science ®Google Scholar
• Teske K, Daut RL, Cleeland CS. Relationships between nurses’ observations and patients’ self-reports of pain. Pain 1983;16:289-96
   PubMed Web of Science ®Google Scholar
• Michel A, Kohlmann T, Raspe H. The association between clinical findings on physical examination and self-reported severity in back pain. Results of a population-based study. Spine 1997;22:296-303
   PubMed Web of Science ®Google Scholar
• Grossman SA, Sheidler VR, Swedeen K, et al. Correlation of patient and caregiver ratings of cancer pain. J Pain Symptom Manage 1991;6:53-7
   PubMed Web of Science ®Google Scholar
• McCombe PF, Fairbank JC, Cockersole BC, et al. 1989 Volvo Award in Clinical Sciences. Reproducibility of physical signs in low-back pain. Spine 1989;14:908-18
   PubMed Web of Science ®Google Scholar
• Potter NA, Rothstein JM. Intertester reliability for selected clinical tests of the sacroiliac joint. Phys Ther 1985;65:1671-5
   PubMed Web of Science ®Google Scholar
• Staiger TO, Paauw DS, Deyo RA, et al. Imaging studies for acute low back pain. When and when not to order them. Postgrad Med 1999;105:161-6, 171
   PubMed Web of Science ®Google Scholar
• Wasiak R, Kim J, Pransky G. Work disability and costs caused by recurrence of low back pain: longer and more costly than in first episodes. Spine 2006;31:219-25
   PubMed Web of Science ®Google Scholar
• Waddell G. The clinical course of low back pain. In: The Back Pain Revolution. Edinburgh, UK: Churchill Livingstone, 1998:103-17
   Google Scholar
• Browning R, Jackson JL, O’Malley PG. Cyclobenzaprine and back pain: a meta-analysis. Arch Intern Med 2001;161:1613-20
   PubMed Web of Science ®Google Scholar
• Greenberg RN. Overview of patient compliance with medication dosing: a literature review. Clin Ther 1984;6:592-9
   PubMed Web of Science ®Google Scholar