Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction in Juvenile Athletes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Schneider, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01449994
First received: July 20, 2011
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Pain in Leg, Unspecified
Knee Sprain
Device: Activator IV (Activator Methods Int. Phoenix, Arizona)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction.A Randomized Placebo-controlled Clinical Study on Juvenile Athletes With Leg Pain

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Reduction of Pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo-Activator
Treatment with Placebo Activator IV
Device: Activator IV (Activator Methods Int. Phoenix, Arizona)
Instruments gives a defined impulse on specified areas of the body
Other Name: Chiropractic adjusting instrument
Active Comparator: Activator
Treatment with Activator IV adjusting instrument
Device: Activator IV (Activator Methods Int. Phoenix, Arizona)
Instruments gives a defined impulse on specified areas of the body
Other Name: Chiropractic adjusting instrument

Detailed Description:

Pain and functional impairment may force young athletes to interrupt training plans and/or even stay away from competition. Usually elite athletes run through an abundance of tests and diagnostic features-too often these high cost diagnostics don´t provide useful information for treatment. Treating the symptoms in the first place (after ruling out severe pathology) will reduce the need for extensive diagnostic routines and bring athletes back to competition earlier.

In our outpatient department of young elite sportsmen chiropractic instrumental treatment is performed routinely- mostly a pain reduction of 3-4 levels in VAS is achieved within the first session of treatment.

The following study is thought to prove the efficacy of the Chiropractic Instrumental Treatment performed at our sports-medicine outpatient department.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • functional problems in the lower extremities

Exclusion Criteria:

  • severe pathology that requires different treatment
  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: NCT01449994

Locations
Austria
MedUni Graz Pediatric Surgery and Ped. Orthopedics
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Frank J Schneider, MD Meical University Graz Department of pediatric orthopedics
  More Information

No publications provided

Responsible Party: Frank Schneider, MD, senior orthopedic surgeon, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01449994     History of Changes
Other Study ID Numbers: Activator in Austria
Study First Received: July 20, 2011
Last Updated: February 7, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
knee
hip
ankle
foot
pain
lower limb
activator
instrumental
chiropractic
Painful functional conditions of the lower extremity

ClinicalTrials.gov processed this record on September 22, 2014