A randomized, double-blind, placebo-controlled multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel in the treatment of acute uncomplicated ankle sprain

Predel, Hans‐Georg; Giannetti, Bruno; Seigfried, Bernd; Novellini, R.; Menke, G

doi:10.1177/0300060513487639

Cited by 13 publications

(4 citation statements)

References 25 publications

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“…Because of the adverse gastrointestinal effects of NSAIDs, effective topical formulations have been successfully used in pain relief of muscle injuries such as sprains and bruises compared to placebo [6][7][8].…”

Section: Introductionmentioning

confidence: 99%

Celecoxib 2% Cream in Acute Soft Tissue Injuries: Randomized, Double-blind, Placebo-controlled Clinical Trial

Geannyne¹,

Amador²,

Silvia³

et al. 2017

Clin Res Foot Ankle

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Objective: The aim of the study was to evaluate the efficacy of pain reduction and tolerability of topical administration of Celecoxib 2% cream compared to Celecoxib 1% cream and placebo cream in Mexican patients who had acute soft tissue injury in lower limbs. Methods:A randomized, double-blind, placebo control trial with 3 parallel groups was conducted. We include Mexicans patients older than 18 years with diagnosis of acute soft tissue injury in lower limbs. They were randomly assigned to Celecoxib 2% cream (CEL-2), Celecoxib 1% cream (CEL-1) or placebo cream (PLA). All treatments should be applied 3 times a day for a period of 7 days. Every day the pain was assessed with a Visual Analogue Scale (VAS). Secondary, we evaluate inflammation and adverse events.Results: A total of 95 patients were included. VAS on day 1 and 7 in group CEL-2 were 57.41 ± 10.39 mm and 4.34 ± 7.02 mm, in CEL-1 59.38 ± 9.37 mm and 10.41 ± 12.78 mm, and in PLA 55.61 ± 8.09 mm and 9.32 ± 9.93 mm. CEL-2 showed greater pain decrease compared to CEL-1 and PLA, p<0.05. CEL-1 group significantly decreased inflammation more than PLA, p<0.05. 15 adverse events were reported in 9 patients, none was severe. Conclusion:The results shown in the present study demonstrate that topical administration of Celecoxib cream 2%, TID for 7 days was effective in pain relief in patients with acute soft tissue injury.

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Section: Introductionmentioning

confidence: 99%

Celecoxib 2% Cream in Acute Soft Tissue Injuries: Randomized, Double-blind, Placebo-controlled Clinical Trial

Geannyne¹,

Amador²,

Silvia³

et al. 2017

Clin Res Foot Ankle

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“…In participants with an acute ankle sprain, diclofenac sodium gel 1% given four times per day was considerably more effective than placebo at lowering pain, edoema, and discomfort, as well as improving ankle joint function (Predel et al, 2013). Overall, systemic and local tolerance to diclofenac sodium gel 1% was good (Efe et al, 2014).…”

Section: Discussionmentioning

confidence: 97%

Effects of diclofenac sodium gel phonophoresis in sports activities induced grade-l ankle sprain

Singh,

Raghav,

Gulyani

et al. 2023

PhR&RHT

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Purpose: the purpose of this study was to evaluate the effect of diclofenac sodium gel phonophoresis in grade -l ankle sprain. Materials & Methods: 54 patients were randomly included in this study and allocated equally into two groups. Group-1 was managed with therapeutic ultrasound (digital ultrasound machine, a product of HMS marketed in India with frequency of 1 MHz and 3MHz) with diclofenac sodium gel and group-2 was managed with therapeutic ultrasound with aquasonic gel. Therapeutic ultrasound with diclofenac sodium gel, marketed under the name of Voltaren, was administered at a frequency of 1MHz, an intensity of 0.8 W/cm2 with continuous mode (1:1) for five times a week for 2 weeks. The patients were examined by using Numeric Pain Rating Scale (NPRS) and Foot and Ankle Disability Index (FADI). They were assessed on the baseline, after 1st week, and after 2nd week of treatment. Results: one way ANOVA test was used to determine the significant difference at the 0.05 level of significance. There was reduction in NPRS and FADI p-value 0.000 after 2nd week of treatment in group-1 and group-2. But on the basis of mean difference score of NPRS and FADI, group-1 was better effective in terms of reduction of pain and improvement of function periodical manner (Table 3). Conclusion: significant dose-dependently relief was observed in NPRS and FADI for pain in disability for each group treated with diclofenac sodium gel compared with aquasonic gel using ultrasound. Acoustic streaming increased these benefits significantly when used after topical application of diclofenac sodium gel, and the dose-dependent effects of diclofenac sodium gel using therapeutic ultrasound.

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“…19 On day 5, the mean changes in the 100-mm VAS pain ratings were À49.1 and À49.7 mm with the diclofenac regimens, respectively, vs. À25.4 mm with placebo (both P < 0.0001). 19 A 1.3% diclofenac epolamine topical patch 20 and a 4% diclofenac spray gel 21 have also shown efficacy over placebo in the treatment of acute ankle sprain. Effective relief of pain associated with acute ankle sprain has also been demonstrated with a variety of other topical NSAIDs, including 5% ibuprofen cream, 22 2% ketorolac gel, 23 a 100-mg/day ketoprofen patch, 24 2.5% niflumic acid gel, 25 and 0.2% mucopolysaccharide polysulphate/2% salicylic acid cream.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

2017

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PurposeThis study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain.DesignIn this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1–3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient’s global assessment of response to treatment.ResultsThere were no statistically significant differences in AUC1–3 between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac.ConclusionNo significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain.ClinicalTrials.Gov Identifier: NCT02100670

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A randomized, double-blind, placebo-controlled multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel in the treatment of acute uncomplicated ankle sprain

Abstract: Diclofenac 4% spray gel rapidly relieves pain and improves mobility in patients with acute, uncomplicated ankle sprain and is well tolerated. It may be a useful treatment option for other acute soft tissue injuries.

Cited by 13 publications

References 25 publications

Celecoxib 2% Cream in Acute Soft Tissue Injuries: Randomized, Double-blind, Placebo-controlled Clinical Trial

Celecoxib 2% Cream in Acute Soft Tissue Injuries: Randomized, Double-blind, Placebo-controlled Clinical Trial

Effects of diclofenac sodium gel phonophoresis in sports activities induced grade-l ankle sprain

Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

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