Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains

May 26, 2011 updated by: University of Virginia
The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.

Study Overview

Detailed Description

The purpose of this protocol is to assess the effects of grade IV anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt
  • Slight reduction in function
  • Anterolateral ankle tenderness
  • Dorsiflexion ROM asymmetry greater than 5° compared to uninvolved limb
  • Posterior talar glide restriction greater than 5° compared to uninvolved limb; or
  • Posterior talar glide less than 19°, which is one standard deviation (7°) from our previously established normative values (26°)9, 10
  • Suffered from grade 1 or 2 lateral ankle sprain within the last 48hr - 8 days

Exclusion Criteria:

  • A history of ankle surgery that involves intra-articular fixation,
  • Syndesmotic ankle sprain (to be ruled out based on clinical examination),
  • History or signs of reflex sympathetic dystrophy,
  • Have received manual therapy for the ankle sprain prior to enrollment
  • Grade III ankle sprain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: "Laying of hands" plus standard therapy
Subjects will lie on their back as if they were receiving the joint mobilization treatment and the therapist will place their hands in a position as if to perform the mobilization but no movement will occur. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression
Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.
Experimental: Standard therapy with joint mobilization
This group will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session, in addition to standard therapy. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression
Subject will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported function
Time Frame: Baseline and four weeks
We hypothesize that the group that receives joint mobilization in addition to standard therapy will show greater improvements in Functional Ankle and Ability Measure (FAAM) and FAAM-Sport (FAAM-S) scores than those who receive standard therapy alone.
Baseline and four weeks
Change in self-reported pain
Time Frame: Baseline and 4 weeks
We hypothesize visual analog scale (VAS) scores for pain will have a greater improvement in those who received joint mobilization in addition to standard therapy when compared to standard therapy alone.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ankle dorsiflexion range of motion
Time Frame: Baseline and 4 weeks
We hypothesize that mobilization when applied to the talocrural joint in addition to standard therapy will result in a greater increase of ankle dorsiflexion ROM than just standard therapy alone.
Baseline and 4 weeks
Change in ligamentous laxity
Time Frame: Baseline and 4 weeks
We hypothesize that ligamentous laxity in both groups will be reduced.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Terry Grindstaff, PhD, DPT, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 26, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 14919

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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