diclofenac has been researched along with Ankle Injuries in 19 studies
Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.
Ankle Injuries: Harm or hurt to the ankle or ankle joint usually inflicted by an external source.
| Excerpt | Relevance | Reference |
|---|---|---|
| "According to these results, diclofenac and paracetamol had the same effect on pain reduction of ankle sprains but more acute ankle edema was present in patients who were treated with diclofenac than in patients who were treated with paracetamol." | 9.15 | Efficacy of paracetamol versus diclofenac for Grade II ankle sprains. ( Lyrtzis, C; Natsis, K; Noussios, G; Papadopoulos, C; Papathanasiou, E, 2011) |
| "It was concluded that diclofenac sodium and paracetamol are effective and well tolerated as a short term treatment alternatives for acute ankle injuries." | 9.12 | The efficacy of paracetamol in the treatment of ankle sprains in comparison with diclofenac sodium. ( Agus, H; Kayali, C; Surer, L; Turgut, A, 2007) |
| "Diclofenac 4% spray gel rapidly relieves pain and improves mobility in patients with acute, uncomplicated ankle sprain and is well tolerated." | 5.17 | 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. ( Giannetti, B; Menke, G; Novellini, R; Predel, HG; Seigfried, B, 2013) |
| "According to these results, diclofenac and paracetamol had the same effect on pain reduction of ankle sprains but more acute ankle edema was present in patients who were treated with diclofenac than in patients who were treated with paracetamol." | 5.15 | Efficacy of paracetamol versus diclofenac for Grade II ankle sprains. ( Lyrtzis, C; Natsis, K; Noussios, G; Papadopoulos, C; Papathanasiou, E, 2011) |
| " The efficacy and tolerability of a novel plaster containing both diclofenac epolamine (DHEP) and heparin in the treatment of acute painful ankle sprains with oedema was investigated in a randomized, double-blind, placebo-controlled study." | 5.14 | Effect of a plaster containing DHEP and heparin in acute ankle sprains with oedema: a randomized, double-blind, placebo-controlled, clinical study. ( Coudreuse, JM; de Vathaire, F, 2010) |
| "Celecoxib, a COX-2 selective inhibitor, is as effective as diclofenac SR in treating ankle sprains." | 5.12 | Efficacy and tolerability of celecoxib compared with diclofenac slow release in the treatment of acute ankle sprain in an Asian population. ( Abrahan, L; Fakir-Bolte, C; Hwang, LJ; Lau, FL; Nadarajah, A, 2006) |
| "It was concluded that diclofenac sodium and paracetamol are effective and well tolerated as a short term treatment alternatives for acute ankle injuries." | 5.12 | The efficacy of paracetamol in the treatment of ankle sprains in comparison with diclofenac sodium. ( Agus, H; Kayali, C; Surer, L; Turgut, A, 2007) |
| "Acute ankle sprains are common and activity limiting injuries, and topical diclofenac gel has proven efficacy in alleviating pain and restoring function." | 2.78 | Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial. ( González de Vega, C; González, J; Speed, C; Wolfarth, B, 2013) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (5.26) | 18.7374 |
| 1990's | 1 (5.26) | 18.2507 |
| 2000's | 5 (26.32) | 29.6817 |
| 2010's | 10 (52.63) | 24.3611 |
| 2020's | 2 (10.53) | 2.80 |
| Authors | Studies |
|---|---|
| Yin, F | 1 |
| Ma, J | 1 |
| Xiao, H | 1 |
| Ao, R | 1 |
| Zhang, F | 1 |
| Li, W | 1 |
| Wang, W | 1 |
| Zeng, P | 1 |
| Lu, T | 1 |
| Revel, FB | 1 |
| Araga, M | 1 |
| Patel, S | 1 |
| Moreira, S | 1 |
| Zhang, J | 1 |
| Zhang, W | 1 |
| Bhanja, DB | 1 |
| Sil, A | 1 |
| Chakraborty, S | 1 |
| Lai, PM | 1 |
| Collaku, A | 1 |
| Reed, K | 1 |
| González de Vega, C | 1 |
| Speed, C | 1 |
| Wolfarth, B | 1 |
| González, J | 1 |
| Predel, HG | 3 |
| Giannetti, B | 3 |
| Seigfried, B | 1 |
| Novellini, R | 1 |
| Menke, G | 1 |
| Coudreuse, JM | 1 |
| de Vathaire, F | 1 |
| Costantino, C | 1 |
| Kwarecki, J | 1 |
| Samokhin, AV | 1 |
| Mautone, G | 2 |
| Rovati, S | 1 |
| Center, DM | 1 |
| Migliorino, R | 1 |
| Lyrtzis, C | 1 |
| Natsis, K | 1 |
| Papadopoulos, C | 1 |
| Noussios, G | 1 |
| Papathanasiou, E | 1 |
| Ortiz, MI | 1 |
| Monroy-Maya, R | 1 |
| Soto-Ríos, M | 1 |
| Carrillo-Alarcón, LC | 1 |
| Ponce-Monter, HA | 1 |
| Rangel-Flores, E | 1 |
| Loo-Estrada, JJ | 1 |
| Izquierdo-Vega, JA | 1 |
| Sánchez-Gutiérrez, M | 1 |
| Hamelsky, S | 1 |
| Gold, M | 1 |
| Mahler, P | 1 |
| Mahler, F | 1 |
| Duruz, H | 1 |
| Ramazzina, M | 1 |
| Liguori, V | 1 |
| Solignac, M | 1 |
| Koll, R | 1 |
| Bulitta, M | 1 |
| Staiger, C | 1 |
| Nadarajah, A | 1 |
| Abrahan, L | 1 |
| Lau, FL | 1 |
| Hwang, LJ | 1 |
| Fakir-Bolte, C | 1 |
| Kayali, C | 1 |
| Agus, H | 1 |
| Surer, L | 1 |
| Turgut, A | 1 |
| Morán, M | 1 |
| Diebschlag, W | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Clinical Study to Assess the Efficacy and Onset of Pain Relief of Topical MFC51123 Diclofenac-Menthol Gel Versus Controls in Ankle Sprain[NCT02100670] | Phase 3 | 385 participants (Actual) | Interventional | 2013-11-01 | Completed | ||
| A Randomized, Controlled, Multi-center Study on the Effectiveness of Traumeel S (Both Ointment and Gel) in Terms of Pain and Function Compared With a Topical NSAID in Athletes With Acute Ankle Sprain[NCT01066520] | Phase 3 | 449 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. (NCT02100670)
Timeframe: up to 72 hours
| Intervention | NRS Score (0 - 10 scale) * hrs (Mean) |
|---|---|
| 1% Diclofenac Sodium Plus (+) 3% Menthol | 276.97 |
| Placebo | 282.88 |
AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. (NCT02100670)
Timeframe: up to 72 hours
| Intervention | NRS Score (0 - 10 scale) * hrs (Mean) |
|---|---|
| 1% Diclofenac Sodium+3% Menthol | 276.97 |
| 1% Diclofenac Sodium | 261.11 |
| 3% Menthol | 272.65 |
| Placebo | 282.88 |
"Time of onset of cooling sensation measured by time when subjects reported to have a 'cooling effect as an enhancement of pain relief'. To assess this endpoint, participants were asked at 10, 30 minutes and at 1, 4, 6 hours post first dose Do you feel a cooling sensation at the injured ankle from the study gel?" (NCT02100670)
Timeframe: up to 6 hours
| Intervention | Hours (Median) |
|---|---|
| 1% Diclofenac Sodium+3% Menthol | 0.17 |
| 1% Diclofenac Sodium | 0.17 |
| 3% Menthol | 0.17 |
| Placebo | 0.17 |
"TOMR was measured by time when participants reported PRS ≥ 2, i.e. some or meaningful pain relief" (NCT02100670)
Timeframe: up to 10 days (end of study)
| Intervention | Hours (Median) |
|---|---|
| 1% Diclofenac Sodium+3% Menthol | 92.50 |
| 1% Diclofenac Sodium | 76.83 |
| 3% Menthol | 72.00 |
| Placebo | 93.50 |
"TOPR was measured by time when participants reported PRS ≥ 1, i.e. a little or perceptible pain relief'." (NCT02100670)
Timeframe: Baseline to 10 days (end of study)
| Intervention | Hours (Median) |
|---|---|
| 1% Diclofenac Sodium+3% Menthol | 1.03 |
| 1% Diclofenac Sodium | 4.00 |
| 3% Menthol | 1.00 |
| Placebo | 4.00 |
Time to complete recovery measured as the day with complete relief of ankle pain (Participant-rated NRS scores were 0 for pain intensity at rest and pain) and swelling (Participants did not have any apparent swelling nor experience any pain or limitation of movement of the injured ankle as determined by the Principal Investigator or designee during the course of an ankle exam). (NCT02100670)
Timeframe: up to 240 hours
| Intervention | Hours (Median) |
|---|---|
| 1% Diclofenac Sodium+3% Menthol | 240.00 |
| 1% Diclofenac Sodium | 240.00 |
| 3% Menthol | 240.00 |
| Placebo | 240.00 |
"Ankle swelling measured by figure of eight method of injured ankle." (NCT02100670)
Timeframe: Day 1 (baseline), 3, and 7
| Intervention | Millimeters (Mean) | ||
|---|---|---|---|
| At Day 1 | At Day 3 | At Day 7 | |
| 1% Diclofenac Sodium | 573.6 | 566.9 | 558.8 |
| 1% Diclofenac Sodium+3% Menthol | 573.9 | 566.2 | 558.3 |
| 3% Menthol | 577.1 | 567.0 | 558.4 |
| Placebo | 576.1 | 565.4 | 557.0 |
"PID on movement, calculated as PI at a given time 't' (after walking 5 steps on a flat surface) subtracted by the PI at baseline.~Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes (min.) and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing." (NCT02100670)
Timeframe: Baseline to 10 days
| Intervention | score on scale (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PI at Baseline (n=117, 112, 77, 75) | PID at 10 min. (n=117, 112, 77, 75) | PID at 30 min. (n=117, 112, 77, 75) | PID at 1 hour (n=117, 112, 77, 75) | PID at 4 hour (n=117, 112, 77, 75) | PID at 6 hour (n=117, 112, 77, 75) | PID at 12 hour (n= 117, 112, 77, 75) | PID at 18 hour (n=117, 112, 77, 75) | PID at 24 hour (n=117, 112, 77, 75) | PID at 36 hour (n=117, 112, 77, 75) | PID at 48 hour (n=117, 112, 77, 75) | PID at 60 hour (n=117, 112, 77, 75) | PID at 72 hour (n=117, 112, 77, 75) | PID at 84 hour (n=113, 107, 75, 75) | PID at 96 hour (n=112, 107, 75, 74) | PID at 108 hour (n=112, 107, 75, 74) | PID at 120 hour (n=111, 107, 74, 74) | PID at 132 hour (n=110, 107, 74, 74) | PID at 144 hour (n=110, 107, 74, 74) | PID at 156 hour (n=109, 107, 74, 74) | PID at 168 hour (n=105, 104, 73, 74) | PID at 180 hour (n=105, 104, 73, 72) | PID at 192 hour (n=101, 102, 71, 72) | PID at 204 hour (n=101, 100, 71, 72) | PID at 216 hour (n=95, 100, 69, 72) | PID at 228 hour (n=95, 100, 69, 72) | PID at 240 hour (n=32, 43, 22, 42) | |
| 1% Diclofenac Sodium | 7.4 | 0.19 | 0.36 | 0.50 | 0.48 | 0.67 | 0.99 | 1.32 | 1.58 | 1.65 | 2.01 | 2.26 | 2.42 | 2.68 | 2.78 | 3.01 | 3.17 | 3.53 | 3.78 | 4.05 | 4.11 | 4.45 | 4.59 | 4.94 | 5.21 | 5.62 | 5.44 |
| 1% Diclofenac Sodium+3% Menthol | 7.8 | 0.23 | 0.44 | 0.56 | 0.71 | 0.79 | 0.84 | 1.19 | 1.62 | 1.59 | 1.91 | 2.41 | 2.55 | 2.84 | 3.10 | 3.34 | 3.38 | 3.70 | 3.76 | 4.17 | 4.26 | 4.58 | 4.55 | 5.17 | 5.28 | 5.71 | 5.56 |
| 3% Menthol | 7.8 | 0.29 | 0.49 | 0.64 | 0.79 | 0.91 | 1.17 | 1.44 | 1.75 | 1.55 | 2.04 | 2.56 | 2.55 | 3.08 | 3.03 | 3.48 | 3.35 | 3.72 | 3.68 | 3.95 | 3.90 | 4.37 | 4.21 | 4.87 | 4.87 | 5.28 | 5.41 |
| Placebo | 7.7 | 0.32 | 0.55 | 0.64 | 0.69 | 0.87 | 0.95 | 1.16 | 1.53 | 1.32 | 1.92 | 2.05 | 2.28 | 2.68 | 2.78 | 3.18 | 3.14 | 3.47 | 3.59 | 3.88 | 3.95 | 4.08 | 4.22 | 4.56 | 4.78 | 5.01 | 5.60 |
Pain relief was measured at each time point using a 5-point Pain Relief Scale ranging from 0-4 while at rest (Where: 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief). Participants assessed the degree of ankle pain relief using the PRS scores at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after the first day of treatment. (NCT02100670)
Timeframe: Day 1 to Day 7
| Intervention | score on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At 10 min. (n= 117, 111, 77, 74) | At 30 min. (n=117, 111, 77, 75) | At 1 hour (n=116, 112, 77, 75) | At 4 hour (n= 115, 110, 74, 71) | At 6 hour (n= 109, 105, 70, 69) | At 12 hour (n= 77, 89, 53, 58) | At 18 hour (n= 76, 78, 53, 57) | At 24 hour (n= 111, 105, 72, 72) | At 36 hour (n= 116, 112, 77, 74) | At 48 hour (n= 116, 112, 77, 75) | At 60 hour (n=115, 111, 77, 75) | At 72 hour (n= 114, 109, 75, 74) | At 84 hour (n= 113, 106, 75, 75) | At 96 hour (n= 112, 106, 75, 74) | At 108 hour (n= 111, 105, 75, 74) | At 120 hour (n= 111, 107, 74, 72) | At 132 hour (n= 110, 107, 73, 74) | At 144 hour (n= 110, 107, 74, 73) | At 156 hour (n= 109, 106, 74, 74) | At 168 hour (n= 105, 103, 73, 73) | |
| 1% Diclofenac Sodium | 0.29 | 0.36 | 0.46 | 0.45 | 0.54 | 0.72 | 0.73 | 0.74 | 0.84 | 0.84 | 1.00 | 1.06 | 1.00 | 1.03 | 1.13 | 1.14 | 1.24 | 1.21 | 1.30 | 1.31 |
| 1% Diclofenac Sodium+3% Menthol | 0.33 | 0.44 | 0.48 | 0.47 | 0.50 | 0.60 | 0.71 | 0.79 | 0.84 | 0.90 | 1.07 | 0.93 | 1.07 | 1.09 | 1.18 | 1.11 | 1.34 | 1.21 | 1.41 | 1.41 |
| 3% Menthol | 0.32 | 0.49 | 0.57 | 0.51 | 0.63 | 0.74 | 0.83 | 0.90 | 0.88 | 0.99 | 1.16 | 1.16 | 1.25 | 1.01 | 1.28 | 1.24 | 1.34 | 1.30 | 1.47 | 1.34 |
| Placebo | 0.36 | 0.44 | 0.40 | 0.49 | 0.45 | 0.62 | 0.70 | 0.81 | 0.78 | 0.99 | 0.96 | 0.97 | 1.11 | 1.09 | 1.15 | 1.10 | 1.30 | 1.27 | 1.32 | 1.40 |
PGART was measured at the end of study in a scale from 0-4 (Where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent) (NCT02100670)
Timeframe: up to Day 10
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| Poor=0 | Fair=1 | Good=2 | Very Good=3 | Excellent=4 | |
| 1% Diclofenac Sodium | 13 | 20 | 46 | 26 | 6 |
| 1% Diclofenac Sodium+3% Menthol | 3 | 24 | 44 | 35 | 9 |
| 3% Menthol | 6 | 12 | 26 | 26 | 5 |
| Placebo | 9 | 14 | 27 | 21 | 4 |
"PID at rest was calculated as PI at a given time point't' (at rest) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain).~PI was measured at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing." (NCT02100670)
Timeframe: Baseline to 10 days
| Intervention | score on a scale (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PI at Baseline (n=117, 112, 77, 75) | PID at 10 min. (n=117, 112, 77, 75) | PID at 30 min. (n=117, 112, 77, 75) | PID at 1 hour (n=117, 112, 77, 75) | PID at 4 hour (n=117, 112, 77, 75) | PID at 6 hour (n= 117, 112, 77, 75) | PID at 12 hour (n= 117, 112, 77, 75) | PID at 18 hour (n= 117, 112, 77, 75) | PID at 24 hour (n= 117, 112, 77, 75) | PID at 36 hour (n= 117, 112, 77, 75) | PID at 48 hour (n=117, 112, 77, 75) | PID at 60 hour (n= 117, 112, 77, 75) | PID at 72 hour (n= 117, 112, 77, 75) | PID at 84 hour (n= 113, 107, 75, 75) | PID at 96 hour (n= 112, 107, 75, 74) | PID at 108 hour (n=112, 107, 75, 74) | PID at 120 hour (n= 111, 107, 74, 74) | PID at 132 hour (n= 110, 107, 74, 74) | PID at 144 hour (n= 110, 107, 74, 74) | PID at 156 hour (n= 109, 107, 74, 74) | PID at 168 hour (n= 105, 104, 73, 74) | PID at 180 hour (n= 105, 104, 73, 72) | PID at 192 hour (n= 101, 102, 71, 72) | PID at 204 hour (n= 101, 100, 71, 72) | PID at 216 hour (n= 95, 100, 69, 72) | PID at 228 hour (n= 95, 100, 69, 72) | PID at 240 hour (n= 32, 43, 22, 42) | |
| 1% Diclofenac Sodium | 7.4 | 0.43 | 0.45 | 0.62 | 0.53 | 0.62 | 0.86 | 1.14 | 1.39 | 1.32 | 1.53 | 1.83 | 1.91 | 2.19 | 2.17 | 2.43 | 2.48 | 2.78 | 2.77 | 3.11 | 3.15 | 3.38 | 3.30 | 3.61 | 3.87 | 4.02 | 4.23 |
| 1% Diclofenac Sodium+3% Menthol | 7.8 | 0.34 | 0.56 | 0.64 | 0.62 | 0.68 | 0.76 | 1.03 | 1.32 | 1.20 | 1.43 | 1.91 | 1.91 | 2.11 | 2.26 | 2.46 | 2.59 | 2.76 | 2.77 | 3.06 | 3.08 | 3.37 | 3.38 | 3.67 | 3.77 | 4.09 | 3.94 |
| 3% Menthol | 7.8 | 0.17 | 0.32 | 0.48 | 0.66 | 0.75 | 0.90 | 1.10 | 1.47 | 1.22 | 1.51 | 1.88 | 1.86 | 2.19 | 2.23 | 2.48 | 2.30 | 2.68 | 2.59 | 2.77 | 2.75 | 2.95 | 2.90 | 3.37 | 3.22 | 3.64 | 3.36 |
| Placebo | 7.7 | 0.25 | 0.44 | 0.41 | 0.43 | 0.53 | 0.68 | 0.85 | 1.13 | 1.09 | 1.45 | 1.64 | 1.76 | 2.03 | 2.00 | 2.27 | 2.09 | 2.49 | 2.49 | 2.65 | 2.64 | 2.88 | 3.00 | 3.21 | 3.26 | 3.53 | 3.67 |
Skin temperature was measured by thermal imaging. (NCT02100670)
Timeframe: At 10, 30, 60 minutes, 4 and 6 hours
| Intervention | degree celsius (°C) (Mean) | ||||
|---|---|---|---|---|---|
| At 10 min. | At 30 min. | At 60 min. | At 240 min. | At 360 min. | |
| 1% Diclofenac Sodium | 29.31 | 29.81 | 30.74 | 31.26 | 31.53 |
| 1% Diclofenac Sodium+3% Menthol | 27.69 | 28.26 | 28.64 | 30.52 | 31.02 |
| 3% Menthol | 29.92 | 30.50 | 30.22 | 31.15 | 31.27 |
| Placebo | 30.93 | 31.47 | 31.78 | 31.57 | 32.07 |
SPID was calculated as the time weighted sum of pain intensity differences (PID) from 0 to 7 Days. PID was calculated as PI at a given time point 't' subtracted by the PI at baseline. PI was measured on NRS scale from 0 (no pain) to 10 (extreme pain). The possible range of SPID for 0-6 hours was from -60 to 60, for 0-12 hours was from -120 to 120, for 0-1 day was from -240 to 240, for 0-3 days was from -720 to 720, for 0-7 days was from -1680 to 1680. A higher value of SPID indicates greater pain relief. (NCT02100670)
Timeframe: Baseline to Day 7
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| At 0-6 hours | At 0-12 hours | At 0-1 days | At 1 to 3 days | At 0 to 7 days | |
| 1% Diclofenac Sodium | 3.19 | 9.13 | 26.54 | 100.07 | 452.44 |
| 1% Diclofenac Sodium+3% Menthol | 4.16 | 9.19 | 26.01 | 101.54 | 451.12 |
| 3% Menthol | 4.72 | 11.74 | 30.91 | 104.26 | 464.96 |
| Placebo | 4.37 | 10.05 | 26.21 | 90.88 | 438.45 |
TOTPAR was calculated as sum of the products of PRS with time interval from one time point to the other. PRS was measured at each time point on a scale: 0= No pain relief, 1= A little or perceptible pain relief, 2= Meaningful pain relief, 3= A lot of relief, 4= Complete relief. The possible range of TOTPAR for 0-6 hours was from 0 to 24, for 0-12 hours was from 0 to 48, for 0-24 hours was from 0 to 96, for 0-72 hours was from 0 to 288, for 24-72 hours was from 0 to 192 and for 0-168 hours was from 0 to 672. (NCT02100670)
Timeframe: Baseline to 168 hours
| Intervention | PRS Score (0 - 4 scale) (Mean) | |||||
|---|---|---|---|---|---|---|
| 0-6 hours | 0-12 hours | 0- 24 hours | 0-72 hours | 24-72 hours | 0-168 hours | |
| 1% Diclofenac Sodium | 2.64 | 6.81 | 16.14 | 61.24 | 45.11 | 170.73 |
| 1% Diclofenac Sodium+3% Menthol | 2.81 | 6.86 | 16.04 | 60.14 | 44.10 | 172.97 |
| 3% Menthol | 3.27 | 8.02 | 18.85 | 66.69 | 47.84 | 184.17 |
| Placebo | 2.75 | 6.35 | 15.71 | 58.75 | 43.04 | 174.00 |
"The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.~Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.~Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction." (NCT01066520)
Timeframe: Day 1 to day 7
| Intervention | Scores on a scale (Median) |
|---|---|
| Traumeel S Ointment | 26.20 |
| Traumeel S Gel | 26.20 |
| Diclofenac Gel | 25.00 |
"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in absolute values." (NCT01066520)
Timeframe: From baseline (day 1) visit to day 7
| Intervention | Absolute value units on a scale VAS (Median) |
|---|---|
| Traumeel S Ointment | -33.00 |
| Traumeel S Gel | -37.10 |
| Diclofenac Gel | -37.10 |
"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in percentages." (NCT01066520)
Timeframe: From baseline (day 1) visit to day 7
| Intervention | Percentage change in scale VAS (Median) |
|---|---|
| Traumeel S Ointment | -60.55 |
| Traumeel S Gel | -71.10 |
| Diclofenac Gel | -68.90 |
1 review available for diclofenac and Ankle Injuries
| Article | Year |
|---|---|
[Assessment of a topical NSAIDs in the treatment of pain and inflammation. The example of Flector Plaster, a local bioadhesive plaster containing diclofenac epolamine].
Topics: Administration, Topical; Animals; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Athletic | 2004 |
15 trials available for diclofenac and Ankle Injuries
| Article | Year |
|---|---|
Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain.
Topics: Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Humans; Pa | 2022 |
Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial.
Topics: Administration, Cutaneous; Adolescent; Adult; Ankle; Ankle Injuries; Anti-Inflammatory Agents, Non-S | 2017 |
Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial.
Topics: Acute Disease; Administration, Cutaneous; Adolescent; Adult; Analgesics; Ankle Injuries; Anti-Inflam | 2013 |
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.
Topics: Acute Disease; Administration, Topical; Adult; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroid | 2013 |
Effect of a plaster containing DHEP and heparin in acute ankle sprains with oedema: a randomized, double-blind, placebo-controlled, clinical study.
Topics: Administration, Topical; Adolescent; Adult; Aged; Ankle Injuries; Anti-Inflammatory Agents, Non-Ster | 2010 |
Diclofenac epolamine plus heparin plaster versus diclofenac epolamine plaster in mild to moderate ankle sprain: a randomized, double-blind, parallel-group, placebo-controlled, multicentre, phase III trial.
Topics: Adolescent; Adult; Aged; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Di | 2011 |
Efficacy of paracetamol versus diclofenac for Grade II ankle sprains.
Topics: Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Ankle Injuries; Anti-Inflammatory Agents | 2011 |
Effectiveness of diclofenac, ketorolac and etoricoxib in the treatment of acute pain from ankle fracture.
Topics: Acute Pain; Adult; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind | 2010 |
Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain.
Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Ankle Injuries; Diclofenac; Dou | 2012 |
Double-blind, randomized, controlled study on the efficacy and safety of a novel diclofenac epolamine gel formulated with lecithin for the treatment of sprains, strains and contusions.
Topics: Acetaminophen; Administration, Topical; Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Ankle Inj | 2003 |
Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study.
Topics: Adolescent; Adult; Ankle Injuries; Area Under Curve; Comfrey; Diclofenac; Female; Gels; Humans; Male | 2005 |
Efficacy and tolerability of celecoxib compared with diclofenac slow release in the treatment of acute ankle sprain in an Asian population.
Topics: Acute Disease; Adult; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Asia; Blood Platelets | 2006 |
The efficacy of paracetamol in the treatment of ankle sprains in comparison with diclofenac sodium.
Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroi | 2007 |
An observer-blind comparison of diclofenac potassium, piroxicam and placebo in the treatment of ankle sprains.
Topics: Adult; Ankle Injuries; Diclofenac; Female; Humans; Male; Middle Aged; Pain; Piroxicam; Single-Blind | 1990 |
[Diclofenac in blunt traumatic ankle joint swelling. Volumetric monitoring in a placebo controlled double-blind trial].
Topics: Adolescent; Adult; Ankle Injuries; Athletic Injuries; Clinical Trials as Topic; Contusions; Diclofen | 1986 |
3 other studies available for diclofenac and Ankle Injuries
| Article | Year |
|---|---|
Intramuscular diclofenac-induced iatrogenic cutaneous necrosis.
Topics: Adult; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Antibiotic Prophylaxis; Diclofenac; | 2020 |
Topical diclofenac for sprains? These doctors say No.
Topics: Administration, Topical; Ankle Injuries; Cyclooxygenase Inhibitors; Diclofenac; Humans; Sprains and | 2011 |
[Naturopathy approaches in sports medicine. Rapid recovery of performance capability].
Topics: Administration, Topical; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Athletic Injuries; | 2012 |