Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
- Conditions
- Grade II and III Acute Lateral Ankle Ligament Injuries
- Registration Number
- NCT01126242
- Lead Sponsor
- Gelre Hospitals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Patients > 18 years
- Grade II or III ankle sprains
- Presentation < 72 hours after the acute injury
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Karlsson score 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.
- Secondary Outcome Measures
Name Time Method Return to work up to 6 months FU Time to return to work Work at level / below level / no return to work
Return to sports up to 6 months FU Time to return to sports Sports at level / below level /no return to sports
Pain VAS up to 6 months FU VAS score 0-10: 0 = no pain, 10 = unbearable pain
Objective stability up to 6 months FU 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) up to 6 months FU Degrees maximum dorsiflexion to plantarflexion
Recurrent inversion injury up to 6 months FU Yes/no Number of sprains per month
Complications / adverse events up to 6 months FU 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 groupTegner activity level up to 6 months FU Mean per group
EuroQol (EQ5D) up to 6 months FU 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 up to 6 months FU 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 up to 6 months FU 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 up to 6 months FU 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.
Trial Locations
- Locations (1)
Gelre Hospitals
🇳🇱Apeldoorn, Netherlands
Gelre Hospitals🇳🇱Apeldoorn, Netherlands