NCT00981331

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

8.2 years

First QC Date

September 21, 2009

Last Update Submit

July 20, 2018

Conditions

Keywords

Subtalar jointMusculoskeletal ManipulationsManipulation, ChiropracticAnkle sprainInversion sprainRange of motion, ArticularQuaternionEigen analysis

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

EXPERIMENTAL

Each subject in this group will recieve a subtalar joint manipulation to their symptomatic ankle

Procedure: Subtalar joint manipulation

Sham Manipulation

SHAM COMPARATOR

Each subject in this group will recieve a sham subtalar joint manipulation to their symptomatic ankle

Procedure: Sham subtalar joint manipulation

Interventions

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

Also known as: Ankle manipulation
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.

Also known as: Sham manipulation
Sham Manipulation

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

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: 7981804BACKGROUND
  • 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.

    PMID: 11347693BACKGROUND
  • 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.

    PMID: 12937564BACKGROUND
  • 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.

    PMID: 11949665BACKGROUND
  • 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.

    PMID: 11276181BACKGROUND
  • 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.

    PMID: 17416272BACKGROUND
  • Hubbard TJ, Hertel J. Mechanical contributions to chronic lateral ankle instability. Sports Med. 2006;36(3):263-77. doi: 10.2165/00007256-200636030-00006.

    PMID: 16526836BACKGROUND
  • 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.

    PMID: 11174691BACKGROUND
  • 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.

    PMID: 12183696BACKGROUND
  • 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.

    PMID: 10914867BACKGROUND
  • 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). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

    PMID: 16182419BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Alexander D Lee, BSc, DC

    Canadian Memorial Chiropractic College

    PRINCIPAL INVESTIGATOR
  • John J Triano, DC, PhD

    Canadian Memorial Chiropractic College

    STUDY DIRECTOR

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

Locations