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

NCT ID: NCT01449994

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-02-29

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.

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.

Conditions

Pain in Leg, Unspecified; Knee Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo-Activator

Treatment with Placebo Activator IV

Group Type: PLACEBO_COMPARATOR

Activator IV (Activator Methods Int. Phoenix, Arizona)

Intervention Type: DEVICE

Instruments gives a defined impulse on specified areas of the body

Activator

Treatment with Activator IV adjusting instrument

Group Type: ACTIVE_COMPARATOR

Activator IV (Activator Methods Int. Phoenix, Arizona)

Intervention Type: DEVICE

Instruments gives a defined impulse on specified areas of the body

Interventions

Activator IV (Activator Methods Int. Phoenix, Arizona)

Instruments gives a defined impulse on specified areas of the body

Intervention Type: DEVICE

Other Intervention Names

Chiropractic adjusting instrument

Eligibility Criteria

Inclusion Criteria

• functional problems in the lower extremities

Exclusion Criteria

• severe pathology that requires different treatment

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Frank Schneider, MD

senior orthopedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank J Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Meical University Graz Department of pediatric orthopedics

Locations

MedUni Graz Pediatric Surgery and Ped. Orthopedics

Graz, Styria, Austria

Countries

Austria

Other Identifiers

Activator in Austria

Identifier Type: -

Identifier Source: org_study_id