title: Delayed-onset muscle soreness: a pilot study to assess analgesic study design features.
abstract: Based on a thorough review of the available literature in the delayed-onset muscle soreness (DOMS) model, we identified multiple study design characteristics that are considered to be normative in acute pain research but have not been followed in a majority of published DOMS experiments. We designed an analgesic investigation using the DOMS model that both complied with current scientifically accepted standards for the conduct of analgesic studies and demonstrated reasonable assay sensitivity. This randomized, double-blind, placebo-controlled within-subject study compared the efficacy of topical diclofenac sodium 1% with a matching placebo in reducing pain associated with DOMS. After exercise, subjects reporting DOMS received topical diclofenac sodium gel 1% (DSG 1%) applied to one leg and placebo to the other every 6 hours for 48 hours. Pain intensity was assessed at rest, upon standing, and when walking in the 48 hours after initial drug application (T0). The primary end point was the reduction in pain intensity (SPID 24) on walking. Subjects receiving DSG 1% had less pain while walking compared with those receiving placebo at 24 hours (SPID 24 = 34.9 [22.9] and 23.6 [19.4], respectively; P = 0.032). This investigation used experimental techniques that have been vetted in the field of exercise physiology and superimposed techniques that are considered to be best practice in the field of analgesic research. Over time and with the help of colleagues in both fields of study, similar investigations will validate design features that impact the assay sensitivity of analgesic end points in DOMS models. In addition, the study confirmed the analgesic efficacy of topical DSG 1% over placebo in subjects experiencing DOMS.
authors: Department of Anesthesia, Lotus Clinical Research, Huntington Hospital, Pasadena, CA, USA, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.
authors: Neil
authors: N
authors: Singla
authors: Paul J
authors: PJ
authors: Desjardins
authors: Evelyn B
authors: EB
authors: Cosca
authors: Cherri
authors: C
authors: Parulan
authors: Anne
authors: A
authors: Arriaga
authors: Kelly C
authors: KC
authors: Poole
authors: Dan M
authors: DM
authors: Batz
authors: Phoebe D
authors: PD
authors: Chang
mesh_terms: D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D004008:Diclofenac / Q000008:administration & dosage; D004311:Double-Blind Method; D015444:Exercise / Q000502:physiology; D005260:Female; D006801:Humans; D008297:Male; D063806:Myalgia / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010865:Pilot Projects; D013997:Time Factors; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D000700:Analgesics; D004008:Diclofenac
references: Clin J Sport Med. 1998 Apr;8(2):82-7
references: 9641434
references: Clin J Sport Med. 2003 Jul;13(4):200-8
references: 12855921
references: Med Sci Sports Exerc. 2010 Mar;42(3):614-21
references: 19952809
references: Neuroimmunomodulation. 2005;12(4):195-200
references: 15990450
references: J Int Soc Sports Nutr. 2009 Jun 05;6:14
references: 19500355
references: Arch Phys Med Rehabil. 2006 Oct;87(10):1310-7
references: 17023239
references: Arch Phys Med Rehabil. 2000 Jul;81(7):966-72
references: 10896014
references: Drugs. 2000 Sep;60(3):555-74
references: 11030467
references: Scand J Med Sci Sports. 2010 Feb;20(1):e195-207
references: 19522751
references: J Physiol. 2004 May 1;556(Pt 3):983-1000
references: 14766942
references: J Strength Cond Res. 2013 Nov;27(11):3101-9
references: 24164961
references: Phytother Res. 2010 Nov;24(11):1620-6
references: 21031618
references: Drug Des Devel Ther. 2009 Sep 21;3:143-9
references: 19920930
references: J Appl Behav Anal. 1979 Summer;12(2):199-210
references: 489478
references: Pain Pract. 2008 Nov-Dec;8(6):433-8
references: 18783359
references: Drugs Aging. 2011 Jan 1;28(1):27-40
references: 21174485
references: Med Sci Sports Exerc. 2001 May;33(5):702-10
references: 11323536
references: J Int Soc Sports Nutr. 2014 Jun 18;11:31
references: 24982601
references: J Rheumatol. 2009 Sep;36(9):1991-9
references: 19648310
references: Pain. 1994 Feb;56(2):217-226
references: 8008411
references: J Strength Cond Res. 2003 Feb;17(1):53-9
references: 12580656