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

NCT01126242 | Completed Phase 4

• 1 other identifier: 09-142
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 months FU

Secondary Outcomes (13)

• Return to work

  up to 6 months FU

• Return to sports

  up to 6 months FU

• Pain VAS

  up to 6 months FU

• Objective stability

  up to 6 months FU

• Objective stability

  up to 6 months FU

Study Arms (3)

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.

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.

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.

Device: Tape; Device: Semi rigid brace; Device: Lace-up brace

Interventions

Tape DEVICE

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.

Lace-up brace; Semi rigid brace; tape

Semi rigid brace DEVICE

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 brace; Semi rigid brace; tape

Lace-up brace DEVICE

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.

Lace-up brace; Semi rigid brace; tape

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gelre Hospitals: lead

Study Sites (1)

Gelre Hospitals

Apeldoorn, 7300 DS, Netherlands

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Eric EJ Raven, MD

  Gelre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 19, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 15, 2016

Record last verified: 2010-04

Locations

NL (1)