Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00971451
Recruitment Status : Unknown
Verified March 2011 by University of Virginia.
Recruitment status was:  Recruiting
First Posted : September 3, 2009
Last Update Posted : March 8, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Other: cryotherapy Other: TENS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
Study Start Date : November 2007
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: knee joint cryotherapy
20 minutes of knee joint cryotherapy - ice bag application
Other: cryotherapy
20 minutes of knee joint cryotherapy - ice bag application

Experimental: TENS
continuous TENS for duration of the 1 hour exercise session
Other: TENS
continuous use of TENS during the exercise session

No Intervention: No intervention
no modality intervention; just exercise

Primary Outcome Measures :
  1. Quadriceps muscle strength and inhibition using the quadriceps central activation ratio [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Quadriceps H-reflex testing [ Time Frame: Day 15 ]
  2. International Knee Documentation Committee Subjective Knee Joint Evaluation [ Time Frame: Day 15 ]
  3. Visual Analog Scale [ Time Frame: Day 15 ]
  4. Tegner Activity Rating [ Time Frame: Day 15 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00971451

Contact: Joseph M Hart, Ph.D. 434-243-0256

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Joseph M Hart, PhD    434-243-0256   
Principal Investigator: Joseph M Hart, Ph.D.         
Sponsors and Collaborators
University of Virginia
Principal Investigator: Joseph M Hart, Ph.D. University of Virginia

Responsible Party: Joseph M. Hart, Ph.D., Assistant Professor, University of Virginia Identifier: NCT00971451     History of Changes
Other Study ID Numbers: 13398
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by University of Virginia:
Anterior cruciate ligament

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries