TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain (TAASS)

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

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.

Study Overview

• Status: Completed
• Conditions: Sprain of Ankle
• Intervention / Treatment: Drug: Traumeel S ointment; Drug: Traumeel S gel; Drug: Diclofenac gel

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.

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • MEDYR Medicina Deportiva y Rehabilitación

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traumeel S ointment; Traumeel S ointment 2 g, 3 times daily topical during 14 days	Drug: Traumeel S ointment; 2 g, 3 times daily topical during 14 days; Other Names: Traumeel S ointment, Traumeel S gel, Diclofenac gel
Experimental: Traumeel S gel; Traumeel S gel 2 g, 3 times daily topical during 14 days	Drug: Traumeel S gel; 2 g, 3 times daily topical during 14 days
Active Comparator: Diclofenac gel; Diclofenac gel 2 g, 3 times daily topical during 14 days	Drug: Diclofenac gel; 2 g, 3 times daily topical during 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline (day 1) visit to day 7
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.	Day 1 to day 7
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.	From baseline (day 1) visit to day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
FAAM ADL Subscale	Day 1 to 4, 14, 42
FAAM Sports Subscale	Day 1 to 4, 7, 14, 42
Swelling ('Figure-of-eight')	Day 1 to 4,7,14
Physician's Assessment of Normal Function/Activity (5-point-scale)	Day 1 to 4, 7, 14, 42
Time to Normal Function (Training/Sports)	Day 1 to 4, 7, 14, 42
Global Judgment of Efficacy	Day 14

Collaborators and Investigators

• Sponsor: Biologische Heilmittel Heel GmbH
• Investigators: Study Chair: Carlos Gonzalez de Vega, MD, National coordinating investigator

Publications and helpful links

General Publications

• Gonzalez de Vega C, Speed C, Wolfarth B, Gonzalez J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract. 2013 Oct;67(10):979-89. doi: 10.1111/ijcp.12219. Epub 2013 Jul 25.

Helpful Links

• Primary publication paper International Journal of Clinical Practice online

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 10, 2010

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: ankle sprain; antiinflammatory; diclofenac; traumeel; time to normal function
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: TRS-ESP; 2008-007939-41 (EudraCT Number)