Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00971451
• Other study ID #: 13398
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2009
• Last updated: March 4, 2011
• Start date: November 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: University of Virginia
• Contact: Joseph M Hart, Ph.D.
• Phone: 434-243-0256
• Email: jmh3zf[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.

All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Complete ACL rupture

2. Age 15-55

Exclusion Criteria:

1. Persons who cannot tolerate knee joint TENS.

2. Persons who have a known allergy to cryotherapy

3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rupture of Anterior Cruciate Ligament

Intervention

Other:
• cryotherapy
20 minutes of knee joint cryotherapy - ice bag application
• TENS
continuous use of TENS during the exercise session

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps muscle strength and inhibition using the quadriceps central activation ratio		Day 15	No
Secondary	Quadriceps H-reflex testing		Day 15	No
Secondary	International Knee Documentation Committee Subjective Knee Joint Evaluation		Day 15	No
Secondary	Visual Analog Scale		Day 15	No
Secondary	Tegner Activity Rating		Day 15	No