Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT00971451

Conditions

Rupture of Anterior Cruciate Ligament

Eligibility Criteria

Sex: All

Age: 15 - 55

Healthy Volunteers: Not accepted

Interventions

cryotherapy

TENS

Study Details

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.

Conditions

Rupture of Anterior Cruciate Ligament

Study ID

NCT00971451

Start date

Nov, 2007

Status verified date

Mar, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 55

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: knee joint cryotherapy

20 minutes of knee joint cryotherapy - ice bag application

experimental: TENS

continuous TENS for duration of the 1 hour exercise session

no intervention: No intervention

no modality intervention; just exercise

Interventions

cryotherapy

20 minutes of knee joint cryotherapy - ice bag application

TENS

continuous use of TENS during the exercise session

Primary outcome measure

  • Quadriceps muscle strength and inhibition using the quadriceps central activation ratio [ Time Frame: Day 15 ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Joseph M Hart, Ph.D.

More Information

Sponsor

University of Virginia

Last update posted

Mar 8, 2011

Last verified

Mar, 2011

Keywords

  • Anterior cruciate ligament
  • ACL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2011-03-08.