NCT01449994

Brief Summary

The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes. A randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed. Hypothesis: Instrumental chiropractic treatment with the "activator instrument "following the "activator methods" diagnostic evaluation should lead to significant improvement of complaints and functional impairment compared to the control group treated by a deactivated instrument following a sham evaluation protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

July 20, 2011

Last Update Submit

February 7, 2012

Conditions

Pain in Leg, UnspecifiedKnee Sprain

Keywords

kneehipanklefootpainlower limbactivatorinstrumentalchiropracticPainful functional conditions of the lower extremity

Outcome Measures

Primary Outcomes (1)

  • Reduction of Pain

    1 week

Study Arms (2)

Placebo-Activator

PLACEBO COMPARATOR

Treatment with Placebo Activator IV

Device: Activator IV (Activator Methods Int. Phoenix, Arizona)

Activator

ACTIVE COMPARATOR

Treatment with Activator IV adjusting instrument

Device: Activator IV (Activator Methods Int. Phoenix, Arizona)

Interventions

Activator IV (Activator Methods Int. Phoenix, Arizona)DEVICE

Instruments gives a defined impulse on specified areas of the body

Also known as: Chiropractic adjusting instrument
ActivatorPlacebo-Activator

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • functional problems in the lower extremities

You may not qualify if:

  • severe pathology that requires different treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedUni Graz Pediatric Surgery and Ped. Orthopedics

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frank J Schneider, MD

    Meical University Graz Department of pediatric orthopedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior orthopedic surgeon

Study Record Dates

First Submitted

July 20, 2011

First Posted

October 10, 2011

Study Start

July 1, 2010

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

AU(1)