Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial.
BACKGROUND
Osteoarthritis is a relatively common musculoskeletal disorder that increases in prevalence with age. Worldwide, knee osteoarthritis is one of the leading causes of disability, particularly in the elderly. In numerous trials of agents for long-term pain therapy, no well-established and replicable results have been achieved. Complementary and alternative medical approaches have been employed for thousands of years to relieve knee osteoarthritis pain. Among herbal medicines, the golden plaster is the preferred and most commonlyused method in China to reduce pain in patients with knee osteoarthritis, as it causes few adverse effects. The purpose of this study will be to evaluate the efficacy and safety of golden plaster on pain in patients with knee osteoarthritis.


METHODS
This study will be a multicenter randomized, double-blind, placebo-controlled trial. A total of 320 participants aged 45 to 79 years with knee osteoarthritis, whose scores on a visual analog scale (VAS) are more than 20 mm,will be randomly allocated into a treatment group and a control group. A golden plaster will be administered externally to participants in the treatment group for 2 weeks, while the control group will receive a placebo plaster externally for 2 weeks. Follow-up will be at regular intervals during a 4-week period with a VAS score for pain, quality of life, and complications.


CONCLUSIONS
This study will be a methodologically sound randomized controlled trial to assess pain relief after the intervention of golden plaster, compared to a placebo intervention in patients with knee osteoarthritis.


BACKGROUND
ClinicalTrials.gov identifier: ChiCTR-TRC-13003418.
Jin-Tao
JT
Liu
Suzhou Hospital of Traditional Chinese Medicine, 889 Wuzhongxi Road, Suzhou, Jiangsu 215009, People's Republic of China. dztang702@126.com.
De-Zhi
DZ
Tang
Xiao-Feng
XF
Li
Zhi-Gang
ZG
Zhang
Wan-Bo
WB
Ji
Shuai
S
Tao
Yong-Jun
YJ
Wang
Hong
H
Jiang
D000279:Administration, Cutaneous; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage*; D018771:Arthralgia / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D057968:Transdermal Patch; D016896:Treatment Outcome
D000700:Analgesics; D004365:Drugs, Chinese Herbal