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Trial record 33 of 346 for:    sprains and strains

Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation

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ClinicalTrials.gov Identifier: NCT00981331
Recruitment Status : Terminated (Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.)
First Posted : September 22, 2009
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Alex Lee, Canadian Memorial Chiropractic College

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).


Condition or disease Intervention/treatment Phase
Ankle Inversion Sprain Procedure: Subtalar joint manipulation Procedure: Sham subtalar joint manipulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2010
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : July 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
Experimental: Subtalar joint manipulation
Each subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle
Procedure: Subtalar joint manipulation
The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.
Other Name: Ankle manipulation

Sham Comparator: Sham Manipulation
Each subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle
Procedure: Sham subtalar joint manipulation
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.
Other Name: Sham manipulation




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Visual Analog Scales for self-reported pain, stiffness, and quality of movement [ Time Frame: Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day) ]
  2. Pain pressure threshold [ Time Frame: Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day) ]
  3. preload force [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ]
  4. peak force [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ]
  5. thrust duration [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ]
  6. force - time slope [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ]
  7. subtalar joint angle [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ]
  8. talocrural joint angle [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ]


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Benign joint hypermobility syndrome (Grahame 2000)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981331


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada, M2H 3J1
Sponsors and Collaborators
Canadian Memorial Chiropractic College
McMaster University
Investigators
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Principal Investigator: Alexander D Lee, BSc, DC Canadian Memorial Chiropractic College
Study Director: John J Triano, DC, PhD Canadian Memorial Chiropractic College

Publications:

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Responsible Party: Alex Lee, Clinician, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT00981331     History of Changes
Other Study ID Numbers: 092025
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Alex Lee, Canadian Memorial Chiropractic College:
Subtalar joint
Musculoskeletal Manipulations
Manipulation, Chiropractic
Ankle sprain
Inversion sprain
Range of motion, Articular
Quaternion
Eigen analysis

Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries