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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00971451
Other study ID # 13398
Secondary ID
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
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