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

Pain in Leg, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449994
• Other study ID #: Activator in Austria
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: February 7, 2012
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• functional problems in the lower extremities

Exclusion Criteria:

• severe pathology that requires different treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Sprain
• Pain in Leg, Unspecified

Intervention

Device:
• Activator IV (Activator Methods Int. Phoenix, Arizona)
Instruments gives a defined impulse on specified areas of the body

Locations

Country	Name	City	State
Austria	MedUni Graz Pediatric Surgery and Ped. Orthopedics	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Pain		1 week	No