Ankle Inversion SprainNCT00981331
Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation
A study testing Subtalar joint manipulation in people with Ankle Inversion Sprain, run by Canadian Memorial Chiropractic College at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Ankle Inversion Sprain
- What is being tested?
- Subtalar joint manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesCanada
- Study dates
- May 2010to 16 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 1C7
Canadian Memorial Chiropractic College
Toronto, Ontario, M2H 3J1
About this study
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.
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).
Read the 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.
- Conditions
- Ankle Inversion Sprain
- Being tested
- Subtalar joint manipulation, Sham subtalar joint manipulation
- Keywords
- Subtalar joint, Musculoskeletal Manipulations, Manipulation, Chiropractic, Ankle sprain, Inversion sprain, Range of motion, Articular, Quaternion, Eigen analysis
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtalar joint manipulationProcedure or surgery
Also called Ankle manipulation
The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.
Sham subtalar joint manipulationProcedure or surgery
Also called Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| Subtalar joint manipulation | Experimental | Each subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle Receives: Procedure: Subtalar joint manipulation |
| Sham Manipulation | Sham comparator | Each subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle Receives: Procedure: Sham subtalar joint manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion determined by a biomechanical ankle model (quaternion eigen analysis)
Measured: 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
Measured: Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day)
Pain pressure threshold
Measured: Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day)
preload force
Measured: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
peak force
Measured: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
thrust duration
Measured: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
force - time slope
Measured: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
subtalar joint angle
Measured: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
talocrural joint angle
Measured: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startMay 2010
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Why it stopped: Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ankle Inversion SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Alex Lee, Canadian Memorial Chiropractic College
- Investigators
- Alexander D Lee, BSc, DC, Principal investigator, Canadian Memorial Chiropractic CollegeJohn J Triano, DC, PhD, Study director, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981331
- Sponsor's protocol ID
- 092025
- Status last verified
- Jul 2018
- First submitted
- 21 Sep 2009
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 7981804Beynnon 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.
PubMed 11347693Denegar 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.
PubMed 12937564Denegar 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.
PubMed 11949665Green 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.
PubMed 11276181Lopez-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.
PubMed 17416272Hubbard TJ, Hertel J. Mechanical contributions to chronic lateral ankle instability. Sports Med. 2006;36(3):263-77. doi: 10.2165/00007256-200636030-00006.
PubMed 16526836Pellow 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.
PubMed 11174691Fryer 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.
PubMed 12183696Grahame 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.
PubMed 10914867Redmond 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.
PubMed 16182419
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00981331
- Acronym / sponsor ID
- 092025
- Conditions
- Ankle Inversion Sprain
- Keywords
- Subtalar joint, Musculoskeletal Manipulations, Manipulation, Chiropractic, Ankle sprain, Inversion sprain, Range of motion, Articular, Quaternion, Eigen analysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- May 2010
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtalar joint manipulation | Experimental | Procedure: Subtalar joint manipulationEach subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle |
| Sham Manipulation | Sham comparator | Procedure: Sham subtalar joint manipulationEach subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtalar joint manipulationAlso: Ankle manipulationThe intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation. | Procedure or surgery | Subtalar joint manipulation |
| Sham subtalar joint manipulationAlso: Sham manipulationThe 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. | Procedure or surgery | Sham Manipulation |
Primary outcome
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)
8 secondary outcomes
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)
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)
preload force
Time frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
peak force
Time frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
thrust duration
Time frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
force - time slope
Time frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
subtalar joint angle
Time frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
talocrural joint angle
Time frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Results and safety
The study was stopped early (reason given: Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 7981804Holmer 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.
- Background: PubMed 11347693Beynnon 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.
- Background: PubMed 12937564Denegar 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.
- Background: PubMed 11949665Denegar 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.
- Background: PubMed 11276181Green 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.
- Background: PubMed 17416272Lopez-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.
- Background: PubMed 16526836Hubbard TJ, Hertel J. Mechanical contributions to chronic lateral ankle instability. Sports Med. 2006;36(3):263-77. doi: 10.2165/00007256-200636030-00006.
- Background: PubMed 11174691Pellow 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.
- Background: PubMed 12183696Fryer 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.
- Background: PubMed 10914867Grahame 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.
- Background: PubMed 16182419Redmond 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander D Lee, BSc, DC principal investigator
Canadian Memorial Chiropractic College
John J Triano, DC, PhD study director
Canadian Memorial Chiropractic College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtalar joint manipulation in people with Ankle Inversion Sprain, run by Canadian Memorial Chiropractic College at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigators and resources are no longer available for completion of the study due to retirements, relocations and reassignments.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981331, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.