Controlled-release oxycodone and naloxone in the treatment of chronic low back pain: A placebo-controlled, randomized study

Pain Research and Management

Volumn 18, Issue 2, 2013, Pages 75-82

  Cloutier, C ^a   Taliano, J ^b   O'Mahony, W ^c   Csanadi, M ^d   Cohen, G ^e   Sutton, I ^f   Sinclair, D ^b   Awde, M ^b   Henein, S ^g   Robinson, L ^h   Eisenhoffer, J ⁱ   Piraino, P S ⁱ   Harsanyi, Z ⁱ   Michalko, K J ⁱ  

^a CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE   (Canada)

^b Family Practice   (Canada)

^c Corunna Medical Research Centre ^*  (Canada)

^d Fort Erie Group Family Practice   (Canada)

^e Brittania Medical Centre   (Canada)

^f HEALTH SCIENCES CENTRE   (Canada)

^g Family Practice SKDS Research Inc   (Canada)

^h Optimal Physiotherapy Clinic   (Canada)

ⁱ PURDUE PHARMA L P   (United States)

Author keywords

Controlled release; Low back pain; Naloxone; Oxycodone

Indexed keywords

COCODAMOL; DOCUSATE SODIUM; DOCUSATE SODIUM PLUS SENNA EXTRACT; NALOXONE; OXYCODONE; PLACEBO;

ABDOMINAL PAIN; ADULT; ARTICLE; CONSTIPATION; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; NAUSEA; OPEN STUDY; PAIN ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SLEEP QUALITY; SOMNOLENCE; UPPER RESPIRATORY TRACT INFECTION; VISUAL ANALOG SCALE; VOMITING; XEROSTOMIA;

EID: 84878330815     PISSN: 12036765     EISSN: None     Source Type: Journal    
DOI: 10.1155/2013/164609     Document Type: Article

References (52)

1. Statistics Canada. Musculoskeletal diseases: Back pain. 〈www.statcan.gc.ca/pub/82-619-m/2006003/4053542-eng.htm〉 (Accessed December 9, 2008).
2. Woolf AD, Pfledger B. Burden of major musculoskeletal conditions. Bulletin of the WHO 2003;81:646-56. (Pubitemid 37254686)
3. Thienhaus O, Cole BE. The classification of pain. In: Weiner RS, ed. Pain Management: A Practical Guide for Clinicians, 6th edn. Boca Raton: CRC Press, 2002:29.
4. Asche CV, Kirkness CS, McAdam-Marx C, Fritz JM. The societal costs of low back pain: Data published between 2001 and 2007. J Pain Palliat Care Pharmacother 2007;21:25-33. (Pubitemid 47585217)
5. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J 2008;8:8-20. (Pubitemid 350299273)
6. Jonsson E. Introductory comments. In: Nachemson A, Jonsson E, eds. Neck and Back Pain: The scientific evidence of causes, diagnosis and treatment. Philadelphia: Lippincott Williams & Wilkins, 2000:2.xiii.
7. Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010(1):CD006605.
8. Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database Syst Rev 2007(3):CD004959.
9. Rossignol M, Arsenault B, Dionne C, et al. Clinic on Low-Back Pain in Interdisciplinary Practice (CLIP) guidelines. Montréal: Direction de santé publique, Agence de la santé et des services sociaux de Montréal, 2007.
10. Top Alberta Doctors. Management of Low Back Pain. [Alberta]: Toward Optimized Practice; 2009 〈www.topalbertadoctors.org/cpgs/back-pain. html〉 (Accessed November 20, 2009).
11. 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. (Pubitemid 351688341)
12. Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain 2010 National Opioid Use Guideline Group (NOUGG). 〈http://nationalpaincentre.mcmaster.ca/opioid/〉 (Accessed March, 2011)
13. Targin Product Monograph, Purdue Pharma, March 30, 2010.
14. Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:114-54.
15. Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Cur Med Res Opin 2008;24:3503-12.
16. Lowenstein O, Leyendecker P, Hopp M, et al. Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: A randomized controlled trial. Expert Opin Pharmacother 2009;10:531-43.
17. Sandner-Kiesling A, Leyendecker P, Hopp M, et al. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. Int J Clin Pract 2010;64:763-74.
18. Schutter U, Grunert S, Meyer C, Schmidt T, Notle T. Innovative pain therapy with a fixed combination of prolonged-release oxycodone/naloxone: A large observational study under conditions of daily practice. Cur Med Res Opin 2010;26:1377-87.
19. Watson CP, Babul N. Efficacy of oxycodone in neuropathic pain: A randomized trial in postherpetic neuralgia. Neurology 1998;50:1837-41. (Pubitemid 28283261)
20. Watson CP, Moulin D, Watt-Watson J, et al. Controlled-release oxycodone relieves neuropathic pain: A randomized controlled trial in painful diabetic neuropathy. Pain 2003;105:71-8. (Pubitemid 37162475)
21. Beaulieu AD, Peloso P, Bensen W, et al. A randomized, double-blind, 8-week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain. Clin Ther 2007;29:49-60. (Pubitemid 46414025)
22. Raffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an "atypical" opioid analgesic. J Pharmacol Exp Ther 1992;260:275-85.
23. Russell A, Watson CPN, Clark AJ, et al. Evaluation of dosing guidelines for use of controlled-release codeine in chronic noncancer pain. Pain Res Manage 2003;8:143-48. (Pubitemid 37461197)
24. Hagen NA, Thirlwell M, Eienhoffer J, Quigley P, Harsanyi Z, Darke A. Efficacy, safety and steady-state pharmacokinetics of once-a-day controlled-release morphine (MS Contin XL) in cancer pain. J Pain Symptom Manage 2005;29:80-90. (Pubitemid 40126227)
25. Arkinstall W, Sandler A, Goughnour B, et al. Efficacy of controlled-release codeine in chronic non-malignant pain: A randomized placebo-controlled trial. Pain 1995;62:169-78.
26. Pollard CA. Preliminary validity study of the Pain Disability Index. Percept Mot Skills. 1984;59:974.
27. Tait RC, Chibnall JT, Krause S. The Pain Disability Index: Psychometric properties. Pain 1990;40:171-82. (Pubitemid 20070786)
28. Kopec JA, Esdaile JM, Abrahamowicz M, et al. The Quebec Back Pain Disability Scale. Measurement properties. Spine 1995;20:341-52.
29. Rentz AM, Yu R, Müller-Lissner S, Leyendecker P. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ 2009;12:371-83.
30. Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: New outcome measure for primary care. BMJ 1992;305:160-4.
31. Bronfort G, Bouter LM. Responsiveness of general health status in chronic low back pain: A comparison of the COOP charts and the SF-36. Pain 1999;83:201-9. (Pubitemid 29479278)
32. Sibley J, Kelly A, Rashiq S, et al. Controlled release oxycodone and acetaminophen plus codeine in chronic low back pain. [Abstract]. 10th World Congress on Pain, San Diego, August 17 to 22, 2002:429.
33. Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physio Ther 2004;27:26-35. (Pubitemid 38125045)
34. Handelsman L, Cochrane KJ, Aronson MJ, Ness R, Rubinstein KJK, Kanoff PD. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse 1987;13:293-308. (Pubitemid 17143298)
35. Elkader AK, Brands B, Callaghan R, Sproule BA. Exploring the relationship between perceived inter-dose opioid withdrawal and patient characteristics in methadone maintenance treatment. Drug Alcohol Depend 2009;105:209-14.
36. Jones B, Kenward MG. Design and Analysis of Cross-Over Trials, 2nd edn. Boca Raton: Chapman & Hall/CRC, 2003.
37. Dworkin R, Turk D, Wyrwich K, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105-21. (Pubitemid 351147828)
38. Mystakidou K, Clark AJ, Fischer J, Lam A, Pappert K, Richarz U. Treatment of chronic pain by long-acting opioids and the effects on sleep. Pain Pract 2011;11:282-9
39. Edwards RR, Almeida DM, Klick B, Haythornthwaite JA, Smith MT. Duration of sleep contributes to next-day pain report in the general population. Pain 2008;137:202-7.
40. Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: A randomized controlled trial. Neurology 2003;60:894-5.
41. Attal N, Guirimand F, Brasseur L, et al. Effects of IV morphine in central pain: A randomized placebo-controlled study. Neurology 2002;58:554-63. (Pubitemid 34164936)
42. Rowbotham MC, Twilling L, Davies PS, et al. Oral opioid therapy for chronic peripheral and central neuropathic pain. N Engl J Med 2003;348:1223-32. (Pubitemid 36359298)
43. OxyContin Product Monograph, August 25, 2009.
44. Martell BA, O'Connor PG, Kems RD, et al. Systematic review: Opioid treatment for chronic back pain: Prevalence, efficacy, and association with addiction. Ann Int Med 2007;146:116-27. (Pubitemid 351640015)
45. Jamison RN, Raymond SA, Slawsby EA, et al. Opioid therapy for chronic noncancer back pain: A randomized prospective study. Spine 1998;23:2591-600. (Pubitemid 29003533)
46. Simpson RK Jr, Edmondson EA, Constant CF, Collier C. Transdermal fentanyl as treatment for chronic low back pain. J Pain Symptom Manage 1997;14:218-24. (Pubitemid 27415739)
47. Muller FO, Odendaal CL, Muller FR, et al. Comparison of the efficacy and tolerability of a paracetamol/codeine fixed-dose combination with tramadol in patients with refractory chronic back pain. Arzneimittelforschung 1998;48:675-9. (Pubitemid 28308194)
48. Hale ME, Fleischmann R, Salzman R, et al. Efficacy and safety of controlled-release versus immediate-release oxycodone: Randomized, double-blind evaluation in patients with chronic back pain. Clin J Pain 1999;15:179-83. (Pubitemid 29467548)
49. Richards P, Zhang P, Friedman M, et al. Controlled release oxycodone releives moderate to severe pain in a 3-month study of persistent moderate to severe back pain. Pain Med 2002;3:176.
50. Portenoy RK, Farrar JT, Backonja M-M, et al. Long-term use of controlled-release oxycodone for non-cancer pain: Results of a 3-year registry study. Clin J Pain. 2007;23:287-99. (Pubitemid 46650020)
51. Hildebrandt J, Lindena G, Maier CH, et al. Long-term treatment with sustained release morphine in non-malignant pain (LAMONTAS). 9th World Congress of Pain, Vienna, August 22 to 27, 1999.
52. Gordon DN, Broughton AN, Miller AJ. Long term efficacy of CR oxycodone (OxyContin tablets) in 101 patients treated for 12 months. 9th World Congress of Pain, Vienna, August 22 to 27, 1999.