Back to resultsEffects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
Primary Purpose
Ankle Sprain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobilization therapy in addition to standard therapy
Sham intervention
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain focused on measuring ankle sprain, athletic injury, arthritis
Eligibility 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.
Sites / Locations
- University of VirginiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
"Laying of hands" plus standard therapy
Standard therapy with joint mobilization
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in self-reported function
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
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
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
We hypothesize that ligamentous laxity in both groups will be reduced.
Full Information
NCT ID
NCT01117909
First Posted
May 4, 2010
Last Updated
May 26, 2011
Sponsor
University of Virginia
Collaborators
American Physical Therapy Association
1. Study Identification
Unique Protocol Identification Number
NCT01117909
Brief Title
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
Official Title
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
Collaborators
American Physical Therapy Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
ankle sprain, athletic injury, arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Laying of hands" plus standard therapy
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Standard therapy with joint mobilization
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Mobilization therapy in addition to standard therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.
Primary Outcome Measure Information:
Title
Change in self-reported function
Description
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.
Time Frame
Baseline and four weeks
Title
Change in self-reported pain
Description
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.
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in ankle dorsiflexion range of motion
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change in ligamentous laxity
Description
We hypothesize that ligamentous laxity in both groups will be reduced.
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Grindstaff, PhD, DPT
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Grindstaff, PhD, DPT
Phone
434-243-2430
Email
tlg6q@virginia.edu
First Name & Middle Initial & Last Name & Degree
Nicole Cosby, MS, ATC
Phone
434-924-6184
Email
nlb4v@virginia.edu
12. IPD Sharing Statement
Learn more about this trial
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
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