Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Not Applicable

• Conditions: Rupture of Anterior Cruciate Ligament
• Interventions: Other: cryotherapy; Other: TENS

• Registration Number: NCT00971451
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-04
• Last Update Posted: 2011-03-08
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
knee joint cryotherapy	cryotherapy	20 minutes of knee joint cryotherapy - ice bag application
TENS	TENS	continuous TENS for duration of the 1 hour exercise session

Primary Outcome Measures

Name	Time	Method
Quadriceps muscle strength and inhibition using the quadriceps central activation ratio	Day 15

Secondary Outcome Measures

Name	Time	Method
Quadriceps H-reflex testing	Day 15
International Knee Documentation Committee Subjective Knee Joint Evaluation	Day 15
Visual Analog Scale	Day 15
Tegner Activity Rating	Day 15

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States