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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by University of Virginia.
Recruitment status was Recruiting

Sponsor:

Collaborator:

American Physical Therapy Association

Information provided by:

University of Virginia

ClinicalTrials.gov Identifier:

NCT01117909

First received: May 4, 2010

Last updated: May 26, 2011

Last verified: May 2011

History of Changes

Purpose

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.

Condition	Intervention
Ankle Sprain	Other: Mobilization therapy in addition to standard therapy Other: Sham intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains

Further study details as provided by University of Virginia:

Primary Outcome Measures:

Change in self-reported function [ Time Frame: Baseline and four weeks ] [ Designated as safety issue: No ]
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.
Change in self-reported pain [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change in ankle dorsiflexion range of motion [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
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.
Change in ligamentous laxity [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
We hypothesize that ligamentous laxity in both groups will be reduced.

Estimated Enrollment:	60
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Other: Sham intervention 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	Other: Mobilization therapy in addition to standard therapy 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.

Arms

Assigned Interventions

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

Other: Sham intervention

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

Other: Mobilization therapy in addition to standard therapy

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117909

Locations

United States, Virginia
University of Virginia	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Terry Grindstaff, PhD, DPT 434-243-2430 tlg6q@virginia.edu
Contact: Nicole Cosby, MS, ATC 434-924-6184 nlb4v@virginia.edu

Sponsors and Collaborators

University of Virginia

American Physical Therapy Association

Investigators

Principal Investigator:

Terry Grindstaff, PhD, DPT

University of Virginia

More Information

No publications provided

Responsible Party:	Dr. Terry Grindstaff, University of Virginia
ClinicalTrials.gov Identifier:	NCT01117909 History of Changes
Other Study ID Numbers:	14919
Study First Received:	May 4, 2010
Last Updated:	May 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Virginia:

ankle sprain
athletic injury
arthritis

Additional relevant MeSH terms:

Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 19, 2013

To Top