Back to resultsTape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
Primary Purpose
Grade II and III Acute Lateral Ankle Ligament Injuries
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Tape
Semi rigid brace
Lace-up brace
Sponsored by
About this trial
This is an interventional treatment trial for Grade II and III Acute Lateral Ankle Ligament Injuries focused on measuring Ankle, ligament injuries, non-surgical treatment, tape, brace, orthotic device, bandage, cost-effectiveness, randomized trial
Eligibility 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
Sites / Locations
- Gelre Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
tape
Lace-up brace
Semi rigid brace
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Karlsson score
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 to return to work Work at level / below level / no return to work
Return to sports
Time to return to sports Sports at level / below level /no return to sports
Pain VAS
VAS score 0-10: 0 = no pain, 10 = unbearable pain
Objective stability
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
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)
Degrees maximum dorsiflexion to plantarflexion
Recurrent inversion injury
Yes/no Number of sprains per month
Complications / adverse events
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
Mean per group
EuroQol (EQ5D)
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01126242
Brief Title
Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
Official Title
Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gelre Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade II and III Acute Lateral Ankle Ligament Injuries
Keywords
Ankle, ligament injuries, non-surgical treatment, tape, brace, orthotic device, bandage, cost-effectiveness, randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tape
Arm Type
Experimental
Arm Description
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.
Arm Title
Lace-up brace
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Semi rigid brace
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tape
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Semi rigid brace
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Lace-up brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Karlsson score
Description
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.
Time Frame
up to 6 months FU
Secondary Outcome Measure Information:
Title
Return to work
Description
Time to return to work Work at level / below level / no return to work
Time Frame
up to 6 months FU
Title
Return to sports
Description
Time to return to sports Sports at level / below level /no return to sports
Time Frame
up to 6 months FU
Title
Pain VAS
Description
VAS score 0-10: 0 = no pain, 10 = unbearable pain
Time Frame
up to 6 months FU
Title
Objective stability
Description
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
Time Frame
up to 6 months FU
Title
Objective stability
Description
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.
Time Frame
up to 6 months FU
Title
Range of motion (ROM)
Description
Degrees maximum dorsiflexion to plantarflexion
Time Frame
up to 6 months FU
Title
Recurrent inversion injury
Description
Yes/no Number of sprains per month
Time Frame
up to 6 months FU
Title
Complications / adverse events
Description
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
Time Frame
up to 6 months FU
Title
Tegner activity level
Description
Mean per group
Time Frame
up to 6 months FU
Title
EuroQol (EQ5D)
Description
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.
Time Frame
up to 6 months FU
Title
Costeffectiveness
Description
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.
Time Frame
up to 6 months FU
Title
Compliance
Description
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)
Time Frame
up to 6 months FU
Title
FAOS
Description
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.
Time Frame
up to 6 months FU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric EJ Raven, MD
Organizational Affiliation
Gelre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gelre Hospitals
City
Apeldoorn
ZIP/Postal Code
7300 DS
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
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