Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

NCT00971451 | Unknown

• 1 other identifier: 13398
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Anterior cruciate ligament; ACL

Outcome Measures

Primary Outcomes (1)

• Quadriceps muscle strength and inhibition using the quadriceps central activation ratio

  Day 15

Secondary Outcomes (4)

• 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

Study Arms (3)

knee joint cryotherapy

EXPERIMENTAL

20 minutes of knee joint cryotherapy - ice bag application

Other: cryotherapy

TENS

EXPERIMENTAL

continuous TENS for duration of the 1 hour exercise session

Other: TENS

No intervention

NO INTERVENTION

no modality intervention; just exercise

Interventions

cryotherapy OTHER

20 minutes of knee joint cryotherapy - ice bag application

knee joint cryotherapy

TENS OTHER

continuous use of TENS during the exercise session

TENS

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Complete ACL rupture
• Age 15-55

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Cryotherapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Joseph M Hart, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph M Hart, Ph.D.

CONTACT

434-243-0256; jmh3zf@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

US (1)