Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Gelre Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gelre Hospitals
ClinicalTrials.gov Identifier:
NCT01126242
First received: May 18, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness.

There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.


Condition Intervention Phase
Grade II and III Acute Lateral Ankle Ligament Injuries
Device: Tape
Device: Semi rigid brace
Device: Lace-up brace
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.

Further study details as provided by Gelre Hospitals:

Primary Outcome Measures:
  • Karlsson score [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    The patients were asked to fill out a questionnaire regarding the function of the ankle joint. The score includes eight items based on a subjective evaluation of stability, pain, swelling and stiffness in relation to activities of everyday life, sports and recreational activities, running, stair climbing and working ability. The maximum score is 100 points.


Secondary Outcome Measures:
  • Return to work [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    Time to return to work Work at level / below level / no return to work

  • Return to sports [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    Time to return to sports Sports at level / below level /no return to sports

  • Pain VAS [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    VAS score 0-10: 0 = no pain, 10 = unbearable pain

  • Objective stability [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]

    Anterior Drawer Test (ADT). The patient sits on a bench with the legs hanging downwards. The knee joint is flexed and the foot held in 150 plantar flexion. First the healthy ankle is examined. Examination is performed according to van Dijk. 38 The examiner assigned one of the four predetermined numbers to each examined ankle joint, based on the estimated anterior displacement of the talus relative to the tibia.

    0 = 0-2mm, 1 = 3-5mm, 2 = 6-10mm and 3 = 11-15mm


  • Objective stability [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    DAAT. Because the manual ADT is of a subjective nature we measure the instability with the dynamic anterior ankle tester (DAAT). 39 The principle of the test is to apply a force impulse tot the calcaneus, within the muscle reflex time, and to measure anterior-posterior translation and mediolateral rotation. The highest and the lowest score were discarded and the mean of the three remaining scores counted as the result of the test.

  • Range of motion (ROM) [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    Degrees maximum dorsiflexion to plantarflexion

  • Recurrent inversion injury [ Time Frame: up to 6 months FU ] [ Designated as safety issue: Yes ]
    Yes/no Number of sprains per month

  • Complications / adverse events [ Time Frame: up to 6 months FU ] [ Designated as safety issue: Yes ]

    Any event leading to discontinuation of study participation and temporary or permanent physical damage due to the treatment under investigation (Local skin irritations (contact dermatitis and folliculitis), sensory deficit, stiffness, muscle atrophy). Use of not allowed painkillers is also an adverse event.

    • Yes / no
    • Total number of complications per patient and per group

  • Tegner activity level [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    Mean per group

  • EuroQol (EQ5D) [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    The EuroQol (EQ5D) is a health related quality of life instrument that provides a single index of an individual's quality of life. It consists of 5 dimensions resulting in 243 possible health states.

  • Costeffectiveness [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    Main objective of the economic evaluation is to assess the cost effectiveness and cost-utility of brace and tape therapy of acute lateral ankle ligament injury. The economic evaluation will be performed from a societal perspective, implying that both direct health care and direct non-health care costs, as well as indirect costs will be used as economic indicators. Firstly, relevant categories of resource utilisation were identified. Secondly, the volume of each category was measured and multiplied by the resource costs.

  • Compliance [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    How many full days did you not wear the (semi rigid / lace-up) brace? Tape compliance is always 100% (except in cases of complications / adverse events)

  • FAOS [ Time Frame: up to 6 months FU ] [ Designated as safety issue: No ]
    FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.


Estimated Enrollment: 182
Study Start Date: May 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tape
Group I will be treated with non-elastic adhesive tape around the affected ankle, applied by the 'van Unen-technique'. This technique is an alternative for the 'Coumans- technique'. The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity. Taping is a treatment that involves no loss of time, requires no crutches and is not attended with any ultimate impairment of function.
Device: Tape
Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18 This technique is an alternative for the 'Coumans- technique'.15 The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Device: Semi rigid brace
Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®. The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression. The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle. The pads are very light and have a soft fleecy surface. Even the edges of the outer moldings are generously padded. The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Device: Lace-up brace
Group III will be treated by application of a lace-up brace, the ASO brace. The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
Active Comparator: Lace-up brace
The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
Device: Tape
Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18 This technique is an alternative for the 'Coumans- technique'.15 The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Device: Semi rigid brace
Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®. The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression. The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle. The pads are very light and have a soft fleecy surface. Even the edges of the outer moldings are generously padded. The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Device: Lace-up brace
Group III will be treated by application of a lace-up brace, the ASO brace. The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
Active Comparator: Semi rigid brace
A semi-rigid brace, the M-step® from Medi®, will be applied. The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression. The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle. The pads are very light and have a soft fleecy surface. Even the edges of the outer moldings are generously padded. The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Device: Tape
Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18 This technique is an alternative for the 'Coumans- technique'.15 The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Device: Semi rigid brace
Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®. The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression. The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle. The pads are very light and have a soft fleecy surface. Even the edges of the outer moldings are generously padded. The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Device: Lace-up brace
Group III will be treated by application of a lace-up brace, the ASO brace. The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.

Detailed Description:

This study is designed as a single blind prospective randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grade II and III acute lateral ankle ligament injuries. The patients will be randomly allocated into one of the three groups. Randomization will be performed by computer. Blinding of patients is not possible, but the observer will be blinded at eight weeks and six months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years
  • Grade II or III ankle sprains
  • Presentation < 72 hours after the acute injury

Exclusion Criteria:

  • Patients with a history of chronic instability
  • Who had a fracture on X-ray investigation
  • Other injuries or disabilities on the same limb
  • Alcoholism, serious psychiatric and neurological illness
  • Patients with bilaterally sprained ankles
  • Patients with previous surgery on the lateral ankle ligaments
  • Skin diseases where taping is not practicable
  • Patients who are unable to give informed consent
  • Patients who are unable to fill out questionnaires
  • Neuromuscular disorders of the lower extremities
  • Active rheumatoid arthritis
  • Gait disturbances
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126242

Contacts
Contact: Michel P. J. van den Bekerom, MD 0031-610807054 bekerom@gmail.com
Contact: Eric E. J. Raven, MD 0031-555818181 e.raven@gelre.nl

Locations
Netherlands
Gelre Hospitals Recruiting
Apeldoorn, Netherlands, 7300 DS
Contact: Michel P.J. van den Bekerom, MD    0031-610807054    bekerom@gmail.com   
Contact: Eric E. J. Raven, MD    0031-555818181    e.raven@gelre.nl   
Sub-Investigator: Michel P. J. van den Bekerom, MD         
Sponsors and Collaborators
Gelre Hospitals
Investigators
Principal Investigator: Eric EJ Raven, MD Gelre Hospital
  More Information

No publications provided

Responsible Party: Eric Raven, MD (orthopaedic Surgeon), Gelre hospitals
ClinicalTrials.gov Identifier: NCT01126242     History of Changes
Other Study ID Numbers: 09-142
Study First Received: May 18, 2010
Last Updated: May 18, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Gelre Hospitals:
Ankle
ligament injuries
non-surgical treatment
tape
brace
orthotic device
bandage
cost-effectiveness
randomized trial

ClinicalTrials.gov processed this record on October 23, 2014