Study Stopped
Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.
Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation
1 other identifier
interventional
28
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2010
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
September 21, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2018
CompletedJuly 24, 2018
July 1, 2018
8.2 years
September 21, 2009
July 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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)
- +3 more secondary outcomes
Study Arms (2)
Subtalar joint manipulation
EXPERIMENTALEach subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle
Sham Manipulation
SHAM COMPARATOREach subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle
Interventions
The intervention is defined as a toggle-recoil, high-velocity, low-amplitude 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Memorial Chiropractic Collegelead
- McMaster Universitycollaborator
Study Sites (2)
McMaster University
Hamilton, Ontario, L8S 1C7, Canada
Canadian Memorial Chiropractic College
Toronto, Ontario, M2H 3J1, Canada
Related Publications (11)
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.
PMID: 7981804BACKGROUNDBeynnon 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.
PMID: 11347693BACKGROUNDDenegar 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.
PMID: 12937564BACKGROUNDDenegar 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.
PMID: 11949665BACKGROUNDGreen 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.
PMID: 11276181BACKGROUNDLopez-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.
PMID: 17416272BACKGROUNDHubbard TJ, Hertel J. Mechanical contributions to chronic lateral ankle instability. Sports Med. 2006;36(3):263-77. doi: 10.2165/00007256-200636030-00006.
PMID: 16526836BACKGROUNDPellow 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.
PMID: 11174691BACKGROUNDFryer 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.
PMID: 12183696BACKGROUNDGrahame 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.
PMID: 10914867BACKGROUNDRedmond 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). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.
PMID: 16182419BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander D Lee, BSc, DC
Canadian Memorial Chiropractic College
- STUDY DIRECTOR
John J Triano, DC, PhD
Canadian Memorial Chiropractic College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician
Study Record Dates
First Submitted
September 21, 2009
First Posted
September 22, 2009
Study Start
May 1, 2010
Primary Completion
July 16, 2018
Study Completion
July 16, 2018
Last Updated
July 24, 2018
Record last verified: 2018-07