Clinical trial NCT01126242: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Gelre Hospitals
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Karlsson score
timeFrame: up to 6 months FU
Secondary outcomes:
measure: Return to work
timeFrame: up to 6 months FU
measure: Return to sports
timeFrame: up to 6 months FU
measure: Pain VAS
timeFrame: up to 6 months FU
measure: Objective stability
timeFrame: up to 6 months FU
measure: Objective stability
timeFrame: up to 6 months FU
measure: Range of motion (ROM)
timeFrame: up to 6 months FU
measure: Recurrent inversion injury
timeFrame: up to 6 months FU
measure: Complications / adverse events
timeFrame: up to 6 months FU
measure: Tegner activity level
timeFrame: up to 6 months FU
measure: EuroQol (EQ5D)
timeFrame: up to 6 months FU
measure: Costeffectiveness
timeFrame: up to 6 months FU
measure: Compliance
timeFrame: up to 6 months FU
measure: FAOS
timeFrame: up to 6 months FU
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
Study officials:
affiliation: Gelre Hospital
name: Eric EJ Raven, MD
role: PRINCIPAL_INVESTIGATOR
References: