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

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01117909
• Other study ID #: 14919
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2010
• Last updated: May 26, 2011
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

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.
• Sham intervention
Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	American Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and four weeks	No
Primary	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.	Baseline and 4 weeks	No
Secondary	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.	Baseline and 4 weeks	No
Secondary	Change in ligamentous laxity	We hypothesize that ligamentous laxity in both groups will be reduced.	Baseline and 4 weeks	No