A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.
acute back pain
acute neck pain
caffeine
ibuprofen
Journal
Journal of pain research
ISSN: 1178-7090
Titre abrégé: J Pain Res
Pays: New Zealand
ID NLM: 101540514
Informations de publication
Date de publication:
2019
2019
Historique:
received:
24
05
2019
accepted:
17
08
2019
entrez:
3
10
2019
pubmed:
3
10
2019
medline:
3
10
2019
Statut:
epublish
Résumé
Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain. Patients with acute lower back/neck pain resulting in pain on movement (POM) ≥5 on a 10-point numerical rating scale were randomized 2:2:1 to receive orally, three times daily for 6 days, 400 mg ibuprofen+100 mg caffeine, 400 mg ibuprofen or placebo, respectively. The primary endpoint was change in POM In total, 635 patients were randomized (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). Active treatments exhibited similar reductions in POM A decrease in lower back/neck pain, indicated by reduced POM
Sections du résumé
BACKGROUND
BACKGROUND
Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain.
METHODS
METHODS
Patients with acute lower back/neck pain resulting in pain on movement (POM) ≥5 on a 10-point numerical rating scale were randomized 2:2:1 to receive orally, three times daily for 6 days, 400 mg ibuprofen+100 mg caffeine, 400 mg ibuprofen or placebo, respectively. The primary endpoint was change in POM
RESULTS
RESULTS
In total, 635 patients were randomized (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). Active treatments exhibited similar reductions in POM
CONCLUSION
CONCLUSIONS
A decrease in lower back/neck pain, indicated by reduced POM
Identifiants
pubmed: 31576162
doi: 10.2147/JPR.S217045
pii: 217045
pmc: PMC6765100
doi:
Types de publication
Journal Article
Langues
eng
Pagination
2771-2783Informations de copyright
© 2019 Predel et al.
Déclaration de conflit d'intérêts
Caty Ebel-Bitoun, Robert Lange and Thomas Weiser are employees at Sanofi Aventis. Hans-Georg Predel has received study grants, honoraria for speaking at congresses and consultancy fees from Sanofi-Aventis and personal fees from Reckitt Benckiser, during the conduct of the study. The authors report no other conflicts of interest in this work.
Références
N Engl J Med. 2001 Feb 1;344(5):363-70
pubmed: 11172169
Postgrad Med. 2018 Jan;130(1):24-31
pubmed: 29110567
Pain Med. 2010 Jun;11(6):951-65
pubmed: 20624245
Lancet. 2014 Nov 1;384(9954):1586-96
pubmed: 25064594
J Neurosurg Spine. 2014 Jan;20(1):83-6
pubmed: 24206036
Arthritis Rheum. 2012 Jun;64(6):2028-37
pubmed: 22231424
Clin Pharmacol Ther. 1991 Jun;49(6):674-84
pubmed: 2060256
J Pain Res. 2016 Dec 14;9:1221-1230
pubmed: 28008281
Pain. 1996 Aug;66(2-3):247-51
pubmed: 8880847
BMC Musculoskelet Disord. 2013 Aug 21;14:250
pubmed: 23964752
BMJ. 2008 Dec 22;337:a2718
pubmed: 19103627
JAMA. 1984 Apr 6;251(13):1711-8
pubmed: 6366275
Pain. 2011 Apr;152(4):726-9
pubmed: 21041029
Int J Clin Pharmacol Ther. 2003 Sep;41(9):375-85
pubmed: 14518597
Clin Ther. 2000 Nov;22(11):1306-18
pubmed: 11117655
Eur J Pain. 2018 Jan;22(1):28-38
pubmed: 28805281
Med Clin North Am. 2014 May;98(3):645-61
pubmed: 24758966
Clin Pharmacol Ther. 2000 Sep;68(3):312-9
pubmed: 11014413
Cochrane Database Syst Rev. 2014 Dec 11;(12):CD009281
pubmed: 25502052
J Clin Pharmacol. 1996 Dec;36(12):1120-5
pubmed: 9013368
Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34
pubmed: 27120496
J Oral Surg. 1977 Nov;35(11):898-903
pubmed: 269932
Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92
pubmed: 21665126
Headache. 2000 Jul-Aug;40(7):561-7
pubmed: 10940094
Phys Sportsmed. 2017 Nov;45(4):418-425
pubmed: 28926295
Ann Rheum Dis. 2017 Jul;76(7):1269-1278
pubmed: 28153830
J Clin Pharmacol. 1989 Nov;29(11):1026-30
pubmed: 2689471