NCT01117909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

May 4, 2010

Last Update Submit

May 26, 2011

Conditions

Keywords

ankle sprainathletic injuryarthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Change in ankle dorsiflexion range of motion

    Baseline and 4 weeks

  • Change in ligamentous laxity

    Baseline and 4 weeks

Study Arms (2)

"Laying of hands" plus standard therapy

SHAM COMPARATOR

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

Standard therapy with joint mobilization

EXPERIMENTAL

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

Interventions

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.

Standard therapy with joint mobilization

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

"Laying of hands" plus standard therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Ankle InjuriesAthletic InjuriesArthritis

Interventions

Hematopoietic Stem Cell Mobilization

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Terry Grindstaff, PhD, DPT

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 6, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations