Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation

Study Overview
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Brief Summary
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The purpose of the study is to determine whether manipulation of the subtalar joint (one of the two joints of the ankle) has an effect on ankle range of motion in a group of ankles that have sustained a subacute inversion ankle sprain. The investigators expect subtalar joint manipulation will increase ankle range of motion about the subtalar joint, but not at the talocrural joint (the other joint of the ankle).

Detailed Description
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Ankle inversion sprain is a common injury that can cause joint stiffness and range of motion deficits.(Holmer 1994, Beynnon 2001, Denegar 2002, Green 2001) Subtalar joint manipulation has been advocated as an intervention for inversion sprains to reduce pain, decrease joint stiffness, and improve range of motion.(Lopez-Rodriguez 2007) The ankle is comprised of the talocrural and subtalar joints and their respective joint axes.(Hubbard 2006) Ankle rotation about these axes can be parameterized using quaternions, a four dimensional unit vector. Range of motion (ROM) about these axes can be determined by performing an eigen analysis of the quaternion matrices to determine the root mean squared values of the motion data about these axes. The objective of the study is to investigate the immediate effects of subtalar joint manipulation on the ROM about the ankle's talocrural and subtalar joints on ankles that have sustained a subacute, grade II inversion sprain. Forty patients with one sprained ankle and one asymptomatic ankle will be recruited. The subjects will be randomized into either a subtalar manipulation group or a sham manipulation group. The sprained ankle of each patient will receive either a standardized subtalar joint manipulation or a sham manipulation. The same patient's asymptomatic ankle will serve as the non-treatment control group. Range of motion pre- and post-manipulation will be quantified utilizing a quaternion eigen analysis. Kinematic and kinetic parameters will be collected during the manipulation to biomechanically characterize the manipulation. Pain pressure threshold and visual analog scale measurements for pain, stiffness, and quality of movement will be collected. Our primary hypothesis is subtalar joint manipulation will increase subtalar ROM, but will have no effect on talocrural ROM. Our secondary hypothesis is subtalar joint manipulation will have positive effects on pain, stiffness, and quality of movement.

Official Title
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Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation in Patients With Sub-acute, Grade II, Ankle Inversion Sprains Quantified Using Quaternion Eigen Analysis.

Conditions
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Ankle Inversion Sprain

Intervention / Treatment
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* Procedure: Subtalar joint manipulation
* Procedure: Sham subtalar joint manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have 1 ankle diagnosed with a subacute, grade II inversion ankle sprain and 1 asymptomatic ankle Pain on palpation of the medial subtalar joint line Manual restriction of subtalar eversion as assessed by a passive joint play test of subtalar joint mobility Exclusion Criteria: (Pellow 2001, Fryer 2002, Lopez-Rodriguez 2007) Acute ankle or foot trauma occurring within 7 days of injury incident Acute or healing fracture Gross ligamentous mechanical instability (grade III ankle sprains) Syndesmosis injury Inflammatory arthritis History of previous medial ankle sprain Medial ankle instability Severely pronated feet determined by Foot Posture Index score > +9 (Redmond 2006) Connective tissue disorder (Grahame 2000) Benign joint hypermobility syndrome (Grahame 2000)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subtalar joint manipulation<br>Each subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle | Procedure: Subtalar joint manipulation<br>* The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.<br>* Other names: Ankle manipulation;|
| Sham Comparator: Sham Manipulation<br>Each subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle | Procedure: Sham subtalar joint manipulation<br>* The sham manipulation is conducted by placing the ankle in a non-manipulative position, and the operator simply engages the toggle board to simulate the audible noise of the toggle board dropping. No force or thrust is applied to the ankle.<br>* Other names: Sham manipulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion determined by a biomechanical ankle model (quaternion eigen analysis) |  | Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on day of testing (ie. 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scales for self-reported pain, stiffness, and quality of movement |  | Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day) | 
| Pain pressure threshold |  | Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day) | 
| preload force |  | Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) | 
| peak force |  | Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) | 
| thrust duration |  | Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) | 
| force - time slope |  | Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) | 
| subtalar joint angle |  | Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) | 
| talocrural joint angle |  | Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subtalar joint, Musculoskeletal Manipulations, Manipulation, Chiropractic, Ankle sprain, Inversion sprain, Range of motion, Articular, Quaternion, Eigen analysis