NCT01121952

Brief Summary

The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
Last Updated

May 12, 2010

Status Verified

April 1, 2010

Enrollment Period

5 months

First QC Date

April 9, 2010

Last Update Submit

May 11, 2010

Conditions

Other Biomechanical LesionsTalo-crural Joint Dysfunction

Keywords

Ankle jointTalo-crural jointVertical jumpChiropractic manipulation (HVLA)ROMProprioceptionPain

Outcome Measures

Primary Outcomes (1)

  • Counter movement jump; IVAR test system

    First assessment: One leg single jump before and after treatment (active or placebo)

    Day 1

Secondary Outcomes (2)

  • Counter movement jump; IVAR test system

    Week one

  • Counter movement jump; IVAR test system

    Week two

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single high-velocity, low-amplitude (HVLA) thrust manipulation towards Tibia, not affecting the dysfunctional talo-crural joint

Other: Chiropractic (HVLA) manipulation

Treatment

EXPERIMENTAL

Single high-velocity, low-amplitude (HVLA long axis) thrust manipulation on dysfunctional talo-crural joint

Other: Chiropractic (HVLA) manipulation

Interventions

Chiropractic (HVLA) manipulationOTHER

Single high-velocity, low-amplitude (HVLA long axis) thrust manipulation to the talo-crural joint, once a week during a three week period

PlaceboTreatment

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First league handball player
  • Talo-crural joint dysfunction
  • Age \>16 yrs

You may not qualify if:

  • Patients with a history of recent trauma or previous operations with remaining fixation material in the foot or ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scandinavian College of Chiropractic

Solna, Stockholm County, 169 57, Sweden

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Håkan A Westerblad, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2010

First Posted

May 12, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 12, 2010

Record last verified: 2010-04

Locations

SE(1)