Changes in the Ankle Range of Motion Following Subtalar Joint Manipulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Canadian Memorial Chiropractic College.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
McMaster University
Information provided by:
Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT00981331
First received: September 21, 2009
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Ankle Inversion Sprain
Procedure: Subtalar joint manipulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • preload force [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ] [ Designated as safety issue: No ]
  • peak force [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ] [ Designated as safety issue: No ]
  • thrust duration [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ] [ Designated as safety issue: No ]
  • force - time slope [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ] [ Designated as safety issue: No ]
  • subtalar joint angle [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ] [ Designated as safety issue: No ]
  • talocrural joint angle [ Time Frame: Outcome measure will be collected during the manipulation on the day of testing (ie. 1 day) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subtalar joint manipulation
Each subject's symptomatic ankle will receive a subtalar joint manipulation.
Procedure: Subtalar joint manipulation
The intervention is defined as a toggle-recoil, high-velocity, low-amplitude subtalar joint manipulation.
Other Name: Ankle manipulation
No Intervention: Non-treatment control
Each subject's asymptomatic ankle will serve as a non-treatment control group that will not receive an intervention.

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.

Twenty patients with one sprained ankle and one asymptomatic ankle will be recruited. The sprained ankle of each patient will receive a standardized subtalar joint 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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981331

Locations
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
Principal Investigator: Alexander D Lee, BSc, DC Canadian Memorial Chiropractic College
Study Director: John J Triano, DC, PhD Canadian Memorial Chiropractic College
  More Information

Publications:

Responsible Party: Alexander D. Lee, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT00981331     History of Changes
Other Study ID Numbers: 092025
Study First Received: September 21, 2009
Last Updated: May 3, 2010
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 20, 2014