Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2005

Open Access 01-12-2005 | Research article

Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]

Authors: Philip A Baer, Lisa M Thomas, Zev Shainhouse

Published in: BMC Musculoskeletal Disorders | Issue 1/2005

Login to get access

Abstract

Background

Topical NSAIDs have been proven to relieve the symptoms of osteoarthritis (OA) in short-term studies (2 weeks). To justify its chronic use, efficacy of a topical NSAID over a longer term of study should be demonstrated. The efficacy and safety of a topical diclofenac solution over a 6-week treatment course in symptomatic primary OA of the knee was investigated.

Methods

216 men and women, age 40–85 years, with radiologically confirmed primary OA of the knee and a flare of pain at baseline following discontinuation of prior therapy were enrolled into this double-blind study. Participants applied either a topical diclofenac solution (Pennsaid®) or vehicle control solution (carrier with no diclofenac); 40 drops 4 times daily directly to the painful knee(s), without massage, for 6 weeks. Pre-planned primary efficacy outcome measures included the core continuous variables pain relief and improved physical function measured by the Western Ontario and McMaster Universities (WOMAC) LK3.1 OA Index, and improved patient global assessment (PGA). Secondary efficacy measure was reduced stiffness. Safety assessments included adverse events and vital signs.

Results

The topical diclofenac group had a significantly greater mean change in score (final minus baseline) compared to the vehicle control group for pain (-5.2 vs. -3.3, p = 0.003), physical function (-13.4 vs. -6.9, p = 0.001), PGA (-1.3 vs. -0.7, p = 0.0001) and stiffness (-1.8 vs. -0.9, p = 0.002). The mean difference between treatment arms (95% confidence interval [CI]) was 1.9 (0.7 to 3.2), 6.5 (2.5 to 10.5), 0.6 (0.2 to 0.9), and 0.9 (0.3 to 1.4), respectively. Safety analyses showed that topical diclofenac caused skin irritation, mostly minor local skin dryness, in 42/107 (39%), leading to discontinuation of treatment in 5/107 (5%) participants.

Conclusion

This topical diclofenac solution demonstrated relief at 6 weeks of the symptoms of primary osteoarthritis of the knee.
Appendix
Available only for authorised users
Literature
1.
2.
Moore RA, Tramer MR, Carroll D, Wiffen PJ, McQuay HJ: Quantitative systematic review of topically applied non-steroidal anti-inflammatory drugs. BMJ. 1998, 316: 333-338.CrossRefPubMedPubMedCentral
3.
Mason L, Moore RA, Edwards JE, Derry S, McQuay HJ: Topical NSAIDs for chronic musculoskeletal pain: systematic review and meta-analysis. BMC Musculoskelet Disord. 2004, 5: 28-10.1186/1471-2474-5-28.CrossRefPubMedPubMedCentral
4.
Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M: EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003, 62: 1145-1155. 10.1136/ard.2003.011742.CrossRefPubMedPubMedCentral
5.
6.
Altman RD, Hochberg MC, Moskowitz RW, Schnitzer TJ: Recommendations for the medical management of osteoarthritis of the hip and knee: New OA practice management guidelines from the ACR. Arthritis Rheum. 2000, 43: 1905-1915. 10.1002/1529-0131(200009)43:9<1905::AID-ANR1>3.0.CO;2-P.CrossRef
7.
Evans JM, McMahon AD, McGilchrist MM, White G, Murray FE, McDevitt DG, MacDonald TM: Topical non-steroidal anti-inflammatory drugs and admission to hospital for upper gastrointestinal bleeding and perforation: a record linkage case-control study. BMJ. 1995, 311: 22-26.CrossRefPubMedPubMedCentral
8.
Lin J, Zhang W, Jones A, Doherty M: Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials. BMJ. 2004, 329: 324-10.1136/bmj.38159.639028.7C.CrossRefPubMedPubMedCentral
9.
Altman RD, Hochberg M, Murphy WAJ, Wolfe F, Lequesne M: Atlas of individual radiographic features in osteoarthritis. Osteoarthritis Cartilage. 1995, 3 Suppl A: 3-70.PubMed
10.
Bellamy N: WOMAC Osteoarthritis Index - A User's Guide. 1995, London, Canada, London Health Sciences Centre
11.
Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, Altman R, Brandt K, Dougados M, Lequesne M: Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997, 24: 799-802.PubMed
12.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW: Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988, 15: 1833-1840.PubMed
13.
Recommendations for the registration of drugs used in the treatment of osteoarthritis. Group for the respect of ethics and excellence in science (GREES): osteoarthritis section. Ann Rheum Dis. 1996, 55: 552-557.
14.
Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M: OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004, 12: 389-399. 10.1016/j.joca.2004.02.001.CrossRefPubMed
15.
Contact allergy: predictive testing in humans. Dermatotoxicology and pharmacology. Advances in modern toxicology. Edited by: Marzulli FN and Maibach HI. 1977, Washington D.C., Hemisphere Publishing, 353-372.
16.
Administration USFD: COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms. 1993, Springfield, VA, National Technical Information Service, US Department of Commerce
17.
18.
Cooper C, Jordan KM: Topical NSAIDs in osteoarthritis. BMJ. 2004, 329: 304-305 doi:10.1136/bmj.329.7461.304 (published 30 July 2004). 10.1136/bmj.329.7461.304.CrossRefPubMedPubMedCentral
19.
Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WAJ, Rosario-Jansen T, Schwartz B, Trippel S: Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage. 1996, 4: 217-243.CrossRefPubMed
20.
Bookman AA, Williams KS, Shainhouse JZ: Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ. 2004, 171: 333-338.CrossRefPubMedPubMedCentral
21.
Roth SH, Shainhouse JZ: Efficacy and safety of a topical diclofenac solution (Pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med. 2004, 164: 2017-2023. 10.1001/archinte.164.18.2017.CrossRefPubMed
22.
Kazis LE, Anderson JJ, Meenan RF: Effect sizes for interpreting changes in health status. Med Care. 1989, 27: S178-S189.CrossRefPubMed
23.
Bjordal JM, Ljunggren AE, Klovning A, Slordal L: Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ. 2004, 329: 1317-10.1136/bmj.38273.626655.63.CrossRefPubMedPubMedCentral
24.
Lee C, Hunsche E, Balshaw R, Kong SX, Schnitzer T: Importance of evaluating common internal controls when assessing the relative efficacy of different pharmacologic agents through a metaanalytic approach: a case study of COX-2-selective inhibitors in the treatment of osteoarthritis. Osteoarthritis Cartilage. 2004, 12 (Supplement B): S74-S75.
25.
Zhang W, Jones A, Doherty M: Does paracetamol (acetaminophen) reduce the pain of osteoarthritis? A meta-analysis of randomised controlled trials. Ann Rheum Dis. 2004, 63: 901-907 doi 10.1136/ard.2003.018531 (published 5 March 2004). 10.1136/ard.2003.018531.CrossRefPubMedPubMedCentral
26.
Osiri M, Suarez-Almazor ME, Wells GA, Robinson V, Tugwell P: Number needed to treat (NNT): implication in rheumatology clinical practice. Ann Rheum Dis. 2003, 62: 316-321. 10.1136/ard.62.4.316.CrossRefPubMedPubMedCentral
27.
Edwards JE, McQuay HJ, Moore RA: Efficacy and safety of valdecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Pain. 2004, 111: 286-296. 10.1016/j.pain.2004.07.004.CrossRefPubMed
28.
Sheldon E, Beaulieu A, Paster Z, Dutta D, Yu S: Lumiracoxib 100 mg once daily is effective in treating osteoarthritis as assessed by OMERACT-OARSI Criteria. Osteoarthritis Cartilage. 2004, 12 (Supplement B): S140-S141.
29.
Ouellet JP, Zacher J, Moore A, Lee A, V.S. S: Long-term efficacy of lumiracoxib in osteoarthritis demonstrated using the OMERACT-OARSI criteria. Osteoarthritis Cartilage. 2004, 12 (Supplement B): S84-S85.
30.
Tugwell PS, Wells GA, Shainhouse JZ: Equivalence study of a topical diclofenac solution (Pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 2004, 31: 2002-2012.PubMed
31.
Hui X, Hewitt PG, Poblete N, Maibach HI, Shainhouse JZ, Wester RC: In vivo bioavailability and metabolism of topical diclofenac lotion in human volunteers. Pharm Res. 1998, 15: 1589-1595. 10.1023/A:1011911302005.CrossRefPubMed
32.
Voltaren Product Monograph. Compendium of Pharmaceuticals and Specialties. Edited by: Association CP. 2004, Ottawa, ON, 2203-2204.
33.
Heyneman CA, Lawless-Liday C, Wall GC: Oral versus topical NSAIDs in rheumatic diseases: a comparison. Drugs. 2000, 60: 555-574.CrossRefPubMed
Metadata
Title
Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]
Authors
Philip A Baer
Lisa M Thomas
Zev Shainhouse
Publication date
01-12-2005
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2005
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-6-44

Other articles of this Issue 1/2005

BMC Musculoskeletal Disorders 1/2005 Go to the issue

Research article

Bone mineral density, body mass index and cigarette smoking among Iranian women: implications for prevention

Research article

Transforming growth factor beta-1 (TGFB1) and peak bone mass: association between intragenic polymorphisms and quantitative ultrasound of the heel

Study protocol

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617]

Research article

Reliability of upright posture measurements in primary school children

Study protocol

A prospective cohort study of surgical treatment for back pain with degenerated discs; study protocol

Research article

Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee or hip: an open, multicentre study