Time to significant pain reduction following DETP application vs placebo for acute soft tissue injuries

Current Medical Research and Opinion

Volumn 26, Issue 8, 2010, Pages 1993-2002

  Yanchick, J ^a   Magelli, M ^a   Bodie, J ^b   Sjogren, J ^a,b   Rovati, S ^c  

^a Alpharma Pharmaceuticals LLC   (United States)

^b MMS HOLDINGS INC   (United States)

^c Institut Biochimique SA   (Switzerland)

Author keywords

Acute injury; Diclofenac; Soft tissue injury; Topical; Visual Analog Scale

Indexed keywords

DICLOFENAC; DICLOFENAC EPOLAMINE; PLACEBO; UNCLASSIFIED DRUG;

ACUTE ANKLE SPRAIN; ADULT; AGED; ANKLE SPRAIN; APPLICATION SITE BURNING; ARTICLE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PAIN; PAIN ASSESSMENT; POST HOC ANALYSIS; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; VISUAL ANALOG SCALE;

ACUTE DISEASE; ADMINISTRATION, TOPICAL; ADOLESCENT; ADULT; AGED; ANKLE JOINT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DICLOFENAC; FEMALE; HUMANS; MALE; MIDDLE AGED; PAIN; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; SOFT TISSUE INJURIES; SPRAINS AND STRAINS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77954697247     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2010.493099     Document Type: Article

References (48)

1. Wolfe MW, Uhl TL, Mattacola CG. Management of ankle sprains. Am Fam Physician 2001;63:93-104
2. Soboroff SH, Pappius EM, Komaroff AL. Benefits, risks, and costs of alternative approaches to the evaluation and treatment of severe ankle sprain. Clin Orthop Relat Res 1984;183:160-8
3. Martin B. Ankle sprain complications: MRI evaluation. Clin Podiatr Med Surg 2008;25:203-47
4. Van Dijk CN. Management of the sprained ankle. Br J Sports Med 2002; 36:83-4
5. Ivins D. Acute ankle sprain: an update. Am Fam Physician 2006;74:1714-20
6. Nadarajah A, Abrahan L, Lau FL, et al. Efficacy and tolerability of celecoxib compared with diclofenac slow release in the treatment of acute ankle sprain in an Asian population. Singapore Med J 2006;47:534-42
7. Ekman EF, Fiechtner JJ, Levy S, et al. Efficacy of celecoxib versus ibuprofen in the treatment of acute pain: a multicenter, double-blind, randomized controlled trial in acute ankle sprain. Am J Orthop 2002;31:445-51
8. Ekman EF, Ruoff G, Kuehl K, et al. The COX-2 specific inhibitor valdecoxib versus tramadol in acute ankle sprain: a multicenter randomized, controlled trial. Am J Sports Med 2006;34:945-55
9. Petrella R, Ekman EF, Schuller R, et al. Efficacy of celecoxib, a COX-2-specific inhibitor, and naproxen in the management of acute ankle sprain: results of a double-blind, randomized controlled trial. Clin J Sport Med 2004;14:225-31
10. Diaz JA, Cuervo C, Valderrama AM, et al. Valdecoxib provides effective pain relief following acute ankle sprain. J Int Med Res 2006;34:456-67
11. Dalton Jr JD, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med 2006;48:615-23
12. Ong CK, Lirk P, Tan CH, et al. An evidence-based update on nonsteroidal anti-inflammatory drugs. Clin Med Res 2007;5:19-34
13. Bertin P, Behier JM, Noel E, et al. Celecoxib is as efficacious as naproxen in the management of acute shoulder pain. J Int Med Res 2003;31:102-12
14. Petri M, Hufman SL, Waser G, et al. Celecoxib effectively treats patients with acute shoulder tendinitis/bursitis. J Rheumatol 2004;31:1614-20
15. Rainsford KD. Anti-inflammatory drugs in the 21st century. Subcell Biochem 2007;42:3-27
16. Graham DJ. COX-2 inhibitors, others NSAIDs, and cardiovascular risk: the seduction of common sense. JAMA 2006;296:1653-6
17. Garća Rodŕguez LA, Hernandez-D́az, S. The risk of upper gastrointestinal complications associated with nonsteroidal anti-inflammatory drugs, glucocorticoids, acetaminophen, and combinations of these agents. Arthritis Res. 2001. 3. 98-101
18. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 1999;340:1888-99
19. Mason L, Moore RA, Edwards JE, etal. Topical NSAIDs for acute pain: a metaanalysis. BMC Fam Pract 2004;5:10
20. Moore RA, Tramer MR, Carroll D, et al. Quantitative systematic review of topically applied non-steroidal anti-inflammatory drugs. BMJ 1998; 316:333-8
21. Esparza F, Cobian C, Jimenez JF, et al. Working group for the acute pain study of SETRADE. Topical ketoprofen TDS patch versus diclofenac gel: efficacy and tolerability in benign sport related soft-tissue injuries. Br J Sports Med 2007;41:134-9
22. Mason L, Moore RA, Edwards JE, et al. Topical NSAIDs for chronic musculoskeletal pain: systematic review and meta-analysis. BMC Musculoskelet Disord 2004;5:28
23. Gimbel J, Linn R, HaleM, etal. Lidocaine patch treatment in patients with low back pain: results of an open-label, nonrandomized pilot study. Am J Ther 2005;12:311-19
24. Evans JM, McMahon AD, McGilchrist MM, et al. Topical nonsteroidal antiinflammatory drugs and admission to hospital for upper gastrointestinal bleeding and perforation: a record linkage case-control study. BMJ 1995; 311:22-6
25. Gallacchi G, Marcolongo R. Pharmacokinetics of diclofenac hydroxyethylpyr-rolidine (DHEP) plasters in patients with monolateral knee joint effusion. Drugs Exp Clin Res 1993;19:95-7
26. Rusca A, Mautone G, Sun S, et al. Comparison of plasma pharmacokinetics of FLECTOR® Patch (diclofenac epolamine topical patch) and oral Voltaren® (diclofenac sodium enteric-coated tablets) in healthy volunteers. 2008 (abstract). Presented at: 27th Annual Scientific Meeting of the American Pain Society, May 8-10 2008, Tampa, FL
27. Assandri A, Canali S, Giachetti C. Local tolerability and pharmacokinetic profile of a new transdermal delivery system, diclofenac hydroxyethylpyrroli- dine plaster. Drugs Exp Clin Res 1993;19:89-95
28. Galer B, Rowbotham M, Perander J, et al. Topical diclofenac patch relieves minor sports injury pain: results of a multicenter controlled clinical trial. J Pain Symptom Manage 2000;19:287-94
29. Rowbotham MC, Galer BS, Block JA, et al. Flector Tissugel®: Efficacite et tolerance dans le traitement des microtraumatismes sportifs. Donnees d'une etude controlee conduite aux Etats-Unis. J Traumatol Sport 2003;20: 1S15-20
30. Saillant G. Etude comparant l'efficacite et la tolerance de Flector Tissugel a celles d'un placebo dans le traitement des entorses benignes de la cheville. Medicine du Sport 1998;72:1-4
31. Joussellin E. Flector Tissugel® in the treatment of painful ankle sprain. J Traumatol Sport 2003;20:1S5-9
32. Jenoure P, Segesser B, Luhti U, et al. A trial with diclofenac HEP plaster as topical treatment in minor sport injuries. Drugs Exp Clin Res 1993;19:125-31
33. Dreiser RL, Tisne-Camus M. DHEP plasters as a topical treatment of knee osteoarthritis-a double-blind placebo-controlled study. Drugs Exp Clin Res 1993;19:117-23
34. Bruhlmann P, Michel BA. Topical diclofenac patch in patients with knee osteoarthritis: a randomized, double-blind, controlled clinical trial. Clin Exp Rheumatol 2003;21:193-8
35. Bruhlmann P, de Vathaire F, Dreiser RL, et al. Short-term treatment with topical diclofenac epolamine plaster in patients with symptomatic knee osteoarthritis: pooled analysis of two randomized clinical studies. Curr Med Res Opin 2006;22:2429-38
36. Jenoure PJ, Rostan A, Gremion G, et al. Multicenter, double-blind, controlled clinical study on the efficacy of diclofenac epolamine-Tissugel plaster in patients with epicondylitis. Med Sport 1997;50:285-92
37. Arroyo J-F, BenguettatD, Hermann F, etal. A study of the short term efficacy of Flector EP-Tissugel® (Diclofenac epolamine) for the local treatment of abarticular pathologies of the shoulder and the knee in elderly subjects. Presented in: Acta Therapeutica Symposium Proceedings, 1994
38. Rosenthal M, Bahous I. A controlled clinical study on the new topical dosage form of DHEP plasters in patients suffering from localized inflammatory diseases. Drugs Exp Clin Res 1993;19:99-105 (Pubitemid 24000676)
39. Galeazzi M, Marcolongo R. A placebo-controlled study of the efficacy and tolerability of a nonsteroidal anti-inflammatory drug, DHEP plaster, in inflammatory peri-and extra-articular rheumatological diseases. Drugs Exp Clin Res 1993;19:107-15
40. Angehrn F. Ein neuer Ansatz in der Behandlung von Patienten mit akuter Thrombophlebitis. Hautnah Schweiz 1999;5:3-11
41. Alessandri F, Lijoi D, Mistrangelo E, et al. Topical diclofenac patch for postoperative wound pain in laparoscopic gynecological surgery: a randomized study. J Minim Invasive Gynecol 2006;13:195-200 (Pubitemid 43674530)
42. Mazieres B, Rouanet S, Velicy J, et al. Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study. Am J Sports Med 2005;33:515-23
43. Malmstrom K, Daniels S, Kotey P, et al. Comparison of rofecoxib and celecoxib, two cyclooxygenase-2 inhibitors, in postoperative dental pain: a randomized, placebo-and active-comparator-controlled clinical trial. Clin Ther 1999;21:1653-63
44. Malmstrom K, Fricke JR, Kotey P, et al. A comparison of rofecexib versus celecoxib in treating pain after dental surgery: a single-center, randomized, double-blind, placebo-and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model. Clin Ther 2002; 24:1549-60
45. Desjardins PJ, Mehlisch DR, Chang DJ, et al. The time to onset and overall analgesic efficacy of rofecoxib 50 mg: a meta-analysis of 13 randomized clinical trials. Clin J Pain 2005;21:241-50
46. Moberly JB, Xu J, Desjardins PJ, et al. A randomized, double-blind, celecoxib-and placebo-controlled study of the effectiveness of CS-706 in acute postoperative dental pain. Clin Ther 2007;29:399-412
47. Hoffman GA, Harrington A, Fields HL. Pain and the placebo: what we have learned. Perspect Biol Med 2005;48:248-65
48. Zubieta JK, Stohler CS. Neurobiological mechanisms of placebo responses. Ann NY Acad Sci 2009;1156:198-210