Grade II and III Acute Lateral Ankle Ligament InjuriesPhase 4NCT01126242
Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
A Phase 4 study testing Tape, Semi rigid brace and Lace-up brace in people with Grade II and III Acute Lateral Ankle Ligament Injuries, run by Gelre Hospitals at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Grade II and III Acute Lateral Ankle Ligament Injuries
- What is being tested?
- Tape, Semi rigid brace and Lace-up brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years
- Grade II or III ankle sprains
- Presentation < 72 hours after the acute injury
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Tape, Semi rigid brace, Lace-up brace
- Keywords
- Ankle, ligament injuries, non-surgical treatment, tape, brace, orthotic device, bandage, cost-effectiveness, randomized trial
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapeDevice
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.
Semi rigid braceDevice
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.
Lace-up braceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tape | Experimental | 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. Receives: Device: Tape; Device: Semi rigid brace; Device: Lace-up brace |
| Lace-up brace | Active comparator | 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. Receives: Device: Tape; Device: Semi rigid brace; Device: Lace-up brace |
| Semi rigid brace | Active comparator | 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. Receives: Device: Tape; Device: Semi rigid brace; Device: Lace-up brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months FU
Secondary outcomes (13)
Return to work
Time to return to work Work at level / below level / no return to work
Measured: up to 6 months FU
Return to sports
Time to return to sports Sports at level / below level /no return to sports
Measured: up to 6 months FU
Pain VAS
VAS score 0-10: 0 = no pain, 10 = unbearable pain
Measured: up to 6 months FU
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
Measured: up to 6 months FU
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.
Measured: up to 6 months FU
Range of motion (ROM)
Degrees maximum dorsiflexion to plantarflexion
Measured: up to 6 months FU
Recurrent inversion injury
Yes/no Number of sprains per month
Measured: up to 6 months FU
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
Measured: up to 6 months FU
Tegner activity level
Mean per group
Measured: up to 6 months FU
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.
Measured: up to 6 months FU
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.
Measured: up to 6 months FU
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)
Measured: up to 6 months FU
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.
Measured: up to 6 months FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade II and III Acute Lateral Ankle Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelre Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel P. J. van den Bekerom, Gelre Hospitals
- Investigators
- Eric EJ Raven, MD, Principal investigator, Gelre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126242
- Sponsor's protocol ID
- 09-142
- Status last verified
- Apr 2010
- First submitted
- 18 May 2010
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
- ClinicalTrials.gov ID
- NCT01126242
- Acronym / sponsor ID
- 09-142
- Keywords
- Ankle, ligament injuries, non-surgical treatment, tape, brace, orthotic device, bandage, cost-effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Gelre HospitalsUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tape | Experimental | Device: Tape, Device: Semi rigid brace, Device: Lace-up braceGroup 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. |
| Lace-up brace | Active comparator | Device: Tape, Device: Semi rigid brace, Device: Lace-up braceThe 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. |
| Semi rigid brace | Active comparator | Device: Tape, Device: Semi rigid brace, Device: Lace-up braceA 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years
- Grade II or III ankle sprains
- Presentation < 72 hours after the acute injury
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TapeGroup 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 | Lace-up brace, Semi rigid brace, tape |
| Semi rigid braceGroup 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, Semi rigid brace, tape |
| Lace-up braceGroup 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. | Device | Lace-up brace, Semi rigid brace, tape |
Primary outcome
Karlsson score
Time frame: up to 6 months FU
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.
13 secondary outcomes
Return to work
Time frame: up to 6 months FU
Return to sports
Time frame: up to 6 months FU
Pain VAS
Time frame: up to 6 months FU
Objective stability
Time frame: up to 6 months FU
Objective stability
Time frame: up to 6 months FU
Range of motion (ROM)
Time frame: up to 6 months FU
Recurrent inversion injury
Time frame: up to 6 months FU
Complications / adverse events
Time frame: up to 6 months FU
Tegner activity level
Time frame: up to 6 months FU
EuroQol (EQ5D)
Time frame: up to 6 months FU
Costeffectiveness
Time frame: up to 6 months FU
Compliance
Time frame: up to 6 months FU
FAOS
Time frame: up to 6 months FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric EJ Raven, MD principal investigator
Gelre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tape, Semi rigid brace and Lace-up brace in people with Grade II and III Acute Lateral Ankle Ligament Injuries, run by Gelre Hospitals at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karlsson score (time frame: up to 6 months FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.