Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

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University of Virginia

Status

Unknown

Conditions

Rupture of Anterior Cruciate Ligament

Treatments

Other: TENS
Other: cryotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00971451
13398

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

15 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Complete ACL rupture
  • Age 15-55

Exclusion criteria

  • Persons who cannot tolerate knee joint TENS.
  • Persons who have a known allergy to cryotherapy
  • Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 3 patient groups

knee joint cryotherapy
Experimental group
Description:
20 minutes of knee joint cryotherapy - ice bag application
Treatment:
Other: cryotherapy
TENS
Experimental group
Description:
continuous TENS for duration of the 1 hour exercise session
Treatment:
Other: TENS
No intervention
No Intervention group
Description:
no modality intervention; just exercise

Trial contacts and locations

1

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Central trial contact

Joseph M Hart, Ph.D.

Data sourced from clinicaltrials.gov

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