Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation

Ankle Inversion Sprain Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00981331
• Other study ID #: 092025
• Status: Terminated
• Phase: N/A
• Start date: May 2010
• Est. completion date: July 16, 2018

Study information

• Verified date: July 2018
• Source: Canadian Memorial Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ankle Inversion Sprain
• Sprains and Strains

Intervention

Procedure:
• Subtalar joint manipulation
The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.
• 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (11)

Beynnon BD, Renström 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Hølmer P, Søndergaard L, Konradsen L, Nielsen PT, Jørgensen LN. Epidemiology of sprains in the lateral ankle and foot. Foot Ankle Int. 1994 Feb;15(2):72-4. — View Citation

Hubbard TJ, Hertel J. Mechanical contributions to chronic lateral ankle instability. Sports Med. 2006;36(3):263-77. — View Citation

López-Rodríguez S, Fernández de-Las-Peñas C, Alburquerque-Sendín F, Rodríguez-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. — View 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. — View 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. Epub 2005 Sep 21. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Pain pressure threshold		Outcome measure will be collected immediately pre-manipulation and immediately post-manipulation on the day of testing (ie. 1 day)
Secondary	preload force		Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Secondary	peak force		Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Secondary	thrust duration		Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Secondary	force - time slope		Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Secondary	subtalar joint angle		Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)
Secondary	talocrural joint angle		Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day)