Sprain of Ankle
Conditions
Keywords
ankle sprain, traumeel, diclofenac, antiinflammatory, time to normal function
Brief summary
The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.
Detailed description
Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.
Interventions
DRUGTraumeel S ointment
2 g, 3 times daily topical during 14 days
DRUGTraumeel S gel
2 g, 3 times daily topical during 14 days
DRUGDiclofenac gel
2 g, 3 times daily topical during 14 days
Sponsors
Biologische Heilmittel Heel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female * Moderate (30-60 mm) to severe (\>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities * 18 - 40 years of age * injury occurred within 24 hours of the first dose of study medication * Willing and able to give written informed consent * Available for the duration of the study
Exclusion criteria
* Similar injury affecting the same joint within the past 6 months * bilateral ankle injury * bed rest, hospitalization, surgery use of a non-removable rigid cast * Clinically important abnormality for screening laboratory tests * Debilitating acute or chronic illness * Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol * History of sensitivity to any component of the study drugs * Unwilling or unable to comply with all the requirements of the protocol * Participation in other studies within 4 weeks prior to study entry and or during the study participation * Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 | From baseline (day 1) visit to day 7 | 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. |
| Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 | Day 1 to day 7 | 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. |
| Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 | From baseline (day 1) visit to day 7 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Physician's Assessment of Normal Function/Activity (5-point-scale) | Day 1 to 4, 7, 14, 42 |
| FAAM ADL Subscale | Day 1 to 4, 14, 42 |
| Global Judgment of Efficacy | Day 14 |
| Time to Normal Function (Training/Sports) | Day 1 to 4, 7, 14, 42 |
| FAAM Sports Subscale | Day 1 to 4, 7, 14, 42 |
| Swelling ('Figure-of-eight') | Day 1 to 4,7,14 |
Countries
Spain
Participant flow
Recruitment details
Initiation date stage I(299 patients):24.08.2009, completion date stage I: 19.01.2011 Initiation date stage II(150 patients): 04.03.2011, completion date stage II: 12.09.2011 The evaluation criteria have not been changed in the different stages. The interim analysis after Stage I re-confirmed the originally calculated sample size.
Pre-assignment details
Athletes of both sexes with acute unilateral sprain of the lateral ankle joint; 18 to 40 years of age; injury occurred within 24 hours of the first dose of study medication, with moderate (30-60mm) to severe (\>60mm) pain on weight bearing.420 of the enrolled 449 patients have been selected into the ITT population. 447 patients received treatment
Participants by arm
| Arm | Count |
|---|---|
| Traumeel S Ointment Traumeel S Ointment 2g, 3 times daily topical during 14 days | 143 |
| Traumeel S Gel Traumeel S Gel 2g, 3 times daily topical during 14 days | 140 |
| Diclofenac Gel Diclofenac Gel 2g, 3 times daily topical during 14 days | 137 |
| Total | 420 |
Baseline characteristics
| Characteristic | Traumeel S Ointment | Traumeel S Gel | Diclofenac Gel | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 143 Participants | 140 Participants | 137 Participants | 420 Participants |
| Region of Enrollment Spain | 143 participants | 140 participants | 137 participants | 420 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 34 Participants | 112 Participants |
| Sex: Female, Male Male | 104 Participants | 101 Participants | 103 Participants | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 152 | 15 / 148 | 8 / 147 |
| serious Total, serious adverse events | 0 / 152 | 0 / 148 | 0 / 147 |
Outcome results
Primary
Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7
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.
Time frame: Day 1 to day 7
Population: Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS\<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traumeel S Ointment | Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 | 26.20 Scores on a scale |
| Traumeel S Gel | Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 | 26.20 Scores on a scale |
| Diclofenac Gel | Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7 | 25.00 Scores on a scale |
Primary
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
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.
Time frame: From baseline (day 1) visit to day 7
Population: Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS\<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traumeel S Ointment | Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 | -33.00 Absolute value units on a scale VAS |
| Traumeel S Gel | Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 | -37.10 Absolute value units on a scale VAS |
| Diclofenac Gel | Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7 | -37.10 Absolute value units on a scale VAS |
Primary
Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7
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.
Time frame: From baseline (day 1) visit to day 7
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traumeel S Ointment | Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 | -60.55 Percentage change in scale VAS |
| Traumeel S Gel | Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 | -71.10 Percentage change in scale VAS |
| Diclofenac Gel | Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7 | -68.90 Percentage change in scale VAS |
Secondary
FAAM ADL Subscale
Time frame: Day 1 to 4, 14, 42
Secondary
FAAM Sports Subscale
Time frame: Day 1 to 4, 7, 14, 42
Secondary
Global Judgment of Efficacy
Time frame: Day 14
Secondary
Physician's Assessment of Normal Function/Activity (5-point-scale)
Time frame: Day 1 to 4, 7, 14, 42
Secondary
Swelling ('Figure-of-eight')
Time frame: Day 1 to 4,7,14
Secondary
Time to Normal Function (Training/Sports)
Time frame: Day 1 to 4, 7, 14, 42