Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation
Primary Purpose
Ankle Inversion Sprain
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Subtalar joint manipulation
Sham subtalar joint manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Inversion Sprain focused on measuring Subtalar joint, Musculoskeletal Manipulations, Manipulation, Chiropractic, Ankle sprain, Inversion sprain, Range of motion, Articular, Quaternion, Eigen analysis
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)
- Benign joint hypermobility syndrome (Grahame 2000)
Sites / Locations
- McMaster University
- Canadian Memorial Chiropractic College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Subtalar joint manipulation
Sham Manipulation
Arm Description
Each subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle
Each subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle
Outcomes
Primary Outcome Measures
Range of Motion determined by a biomechanical ankle model (quaternion eigen analysis)
Secondary Outcome Measures
Visual Analog Scales for self-reported pain, stiffness, and quality of movement
Pain pressure threshold
preload force
peak force
thrust duration
force - time slope
subtalar joint angle
talocrural joint angle
Full Information
NCT ID
NCT00981331
First Posted
September 21, 2009
Last Updated
July 20, 2018
Sponsor
Canadian Memorial Chiropractic College
Collaborators
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT00981331
Brief Title
Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Memorial Chiropractic College
Collaborators
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Inversion Sprain
Keywords
Subtalar joint, Musculoskeletal Manipulations, Manipulation, Chiropractic, Ankle sprain, Inversion sprain, Range of motion, Articular, Quaternion, Eigen analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subtalar joint manipulation
Arm Type
Experimental
Arm Description
Each subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle
Arm Title
Sham Manipulation
Arm Type
Sham Comparator
Arm Description
Each subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle
Intervention Type
Procedure
Intervention Name(s)
Subtalar joint manipulation
Other Intervention Name(s)
Ankle manipulation
Intervention Description
The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.
Intervention Type
Procedure
Intervention Name(s)
Sham subtalar joint manipulation
Other Intervention Name(s)
Sham manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
preload force
Time Frame
Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Title
peak force
Time Frame
Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Title
thrust duration
Time Frame
Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Title
force - time slope
Time Frame
Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Title
subtalar joint angle
Time Frame
Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Title
talocrural joint angle
Time Frame
Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Benign joint hypermobility syndrome (Grahame 2000)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander D Lee, BSc, DC
Organizational Affiliation
Canadian Memorial Chiropractic College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John J Triano, DC, PhD
Organizational Affiliation
Canadian Memorial Chiropractic College
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada
Facility Name
Canadian Memorial Chiropractic College
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2H 3J1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7981804
Citation
Holmer P, Sondergaard L, Konradsen L, Nielsen PT, Jorgensen LN. Epidemiology of sprains in the lateral ankle and foot. Foot Ankle Int. 1994 Feb;15(2):72-4. doi: 10.1177/107110079401500204.
Results Reference
background
PubMed Identifier
11347693
Citation
Beynnon BD, Renstrom PA, Alosa DM, Baumhauer JF, Vacek PM. Ankle ligament injury risk factors: a prospective study of college athletes. J Orthop Res. 2001 Mar;19(2):213-20. doi: 10.1016/S0736-0266(00)90004-4.
Results Reference
background
PubMed Identifier
12937564
Citation
Denegar CR, Miller SJ 3rd. Can Chronic Ankle Instability Be Prevented? Rethinking Management of Lateral Ankle Sprains. J Athl Train. 2002 Dec;37(4):430-435.
Results Reference
background
PubMed Identifier
11949665
Citation
Denegar CR, Hertel J, Fonseca J. The effect of lateral ankle sprain on dorsiflexion range of motion, posterior talar glide, and joint laxity. J Orthop Sports Phys Ther. 2002 Apr;32(4):166-73. doi: 10.2519/jospt.2002.32.4.166.
Results Reference
background
PubMed Identifier
11276181
Citation
Green T, Refshauge K, Crosbie J, Adams R. A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains. Phys Ther. 2001 Apr;81(4):984-94.
Results Reference
background
PubMed Identifier
17416272
Citation
Lopez-Rodriguez S, Fernandez de-Las-Penas C, Alburquerque-Sendin F, Rodriguez-Blanco C, Palomeque-del-Cerro L. Immediate effects of manipulation of the talocrural joint on stabilometry and baropodometry in patients with ankle sprain. J Manipulative Physiol Ther. 2007 Mar-Apr;30(3):186-92. doi: 10.1016/j.jmpt.2007.01.011.
Results Reference
background
PubMed Identifier
16526836
Citation
Hubbard TJ, Hertel J. Mechanical contributions to chronic lateral ankle instability. Sports Med. 2006;36(3):263-77. doi: 10.2165/00007256-200636030-00006.
Results Reference
background
PubMed Identifier
11174691
Citation
Pellow JE, Brantingham JW. The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains. J Manipulative Physiol Ther. 2001 Jan;24(1):17-24. doi: 10.1067/mmt.2001.112015.
Results Reference
background
PubMed Identifier
12183696
Citation
Fryer GA, Mudge JM, McLaughlin PA. The effect of talocrural joint manipulation on range of motion at the ankle. J Manipulative Physiol Ther. 2002 Jul-Aug;25(6):384-90. doi: 10.1067/mmt.2002.126129.
Results Reference
background
PubMed Identifier
10914867
Citation
Grahame R, Bird HA, Child A. The revised (Brighton 1998) criteria for the diagnosis of benign joint hypermobility syndrome (BJHS). J Rheumatol. 2000 Jul;27(7):1777-9. No abstract available.
Results Reference
background
PubMed Identifier
16182419
Citation
Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol, Avon). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.
Results Reference
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Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation
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