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Clinical Trials/NCT00981331
NCT00981331
Terminated
Not Applicable

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.

Canadian Memorial Chiropractic College2 sites in 1 country28 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Inversion Sprain
Sponsor
Canadian Memorial Chiropractic College
Enrollment
28
Locations
2
Primary Endpoint
Range of Motion determined by a biomechanical ankle model (quaternion eigen analysis)
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
July 16, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alex Lee

Clinician

Canadian Memorial Chiropractic College

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Range of Motion determined by a biomechanical ankle model (quaternion eigen analysis)

Time Frame: Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on day of testing (ie. 1 day)

Secondary Outcomes

  • 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))
  • Pain pressure threshold(Outcome measure will be collected immediately pre-manipulation and immediately post-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))
  • thrust duration(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))
  • 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))

Study Sites (2)

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