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Completed

NCT Number: NCT01066520

TAASS-Traumeel Ointment and Gel 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.

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Key information

Conditions

Sprain of Ankle Ankle Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MEDYR Medicina Deportiva y Rehabilitación

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traumeel S ointment

Drug

2 g, 3 times daily topical during 14 days

Other names: Traumeel S ointment, Traumeel S gel, Diclofenac gel

Traumeel S gel

Drug

2 g, 3 times daily topical during 14 days

Diclofenac Gel

Drug

2 g, 3 times daily topical during 14 days

Primary outcomes

  1. Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7

    Time frame: 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.

  2. Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7

    Time frame: 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.

  3. Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7

    Time frame: 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 outcomes

  1. FAAM ADL Subscale

    Time frame: Day 1 to 4, 14, 42

  2. FAAM Sports Subscale

    Time frame: Day 1 to 4, 7, 14, 42

  3. Swelling ('Figure-of-eight')

    Time frame: Day 1 to 4,7,14

  4. Physician's Assessment of Normal Function/Activity (5-point-scale)

    Time frame: Day 1 to 4, 7, 14, 42

  5. Time to Normal Function (Training/Sports)

    Time frame: Day 1 to 4, 7, 14, 42

  6. Global Judgment of Efficacy

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Biologische Heilmittel Heel GmbH

Industry

Registry information

Official study title

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

Acronym: TAASS

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 10, 2010
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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