menthol has been researched along with Ankle Injuries in 1 studies
Menthol: A monoterpene cyclohexanol produced from mint oils.
Ankle Injuries: Harm or hurt to the ankle or ankle joint usually inflicted by an external source.
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Lai, PM | 1 |
| Collaku, A | 1 |
| Reed, K | 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 | ||
| [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 |
1 trial available for menthol and Ankle Injuries
| Article | Year |
|---|---|
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 |