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The effect of home electrical stimulation and intra-operative femoral nerve blockage on outcomes after anterior cruciate ligament reconstruction

The effect of home electrical stimulation and intra-operative femoral nerve blockage on outcomes after anterior cruciate ligament reconstruction: a prospective, randomized controlled trial with cross-over design

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15816734
Enrollment
120
Registered
2015-07-16
Start date
2012-01-06
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletes with a torn ACL (anterior cruciate ligament) Injury, Occupational Diseases, Poisoning

Interventions

Each subject will receive the medical and rehabilitative standard of care following ACL injury from OSU sports medicine. Medically, if the patient elects to undergo surgical intervention, they will be

Sponsors

Empi, Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for athletes with ACL reconstruction: 1. 14-49 years old 2. Prior to injury, athletes participated in level I/II cutting, pivoting, jumping, and lateral movement sports at least 50 hours/year 3. Acute unilateral ACL tear with plan for reconstruction with hamstring autograft 4. All eligible patients must provide written informed consent (assent for children ages 14-17) prior to participation

Exclusion criteria

Exclusion criteria: Exclusion criteria for athletes with ACL reconstruction: 1. Prior ACLR (either ipsilateral or contralateral) 2. Patients who have a medical history that includes serious lower extremity injury or surgery (i.e., anterior cruciate ligament reconstruction, fractures) that may affect performance of dynamic jumping tasks 3. Patients who have a medical history of heart disease, ischemia of the lower limbs, arterial/circulation problems, rheumatic disease, epilepsy, any infectious disease, or anyone who has a pacemaker, defibrillator, or any other kind of electrical or metal implants 4. Patients who medically necessitate immediate (less than 2 weeks) surgical intervention to address secondary injury as determined by MD 5. Women who are currently pregnant 6. Patients who will not be in the Columbus area for 2 years

Design outcomes

Primary

MeasureTime frame
1. Disease-specific questionnaires, including the International Knee Documentation Committee (IKDC), Knee Osteoarthritis Outcome Score (KOOS), the Marx Activity Scale, and the SF-36 Health Survey 2. Magnetic resonance imaging (MRI) - in addition to the six weeks post-operative clinical assessment, the subjects will undergo a post-operative MRI of the knee and thigh regions, bilaterally. The purpose of the MRI is to assess the cross-sectional area of the quadriceps musculature post-operatively compared to the contralateral limb to report on the change in the muscle size during the course of the intervention.

Secondary

MeasureTime frame
1. Clinical assessment - each subject will undergo repeated measures of standard clinical assessment tools to longitudinally assess progress prior to ACLR and throughout the post-operative rehabilitation course. Clinical and functional variables of interest include: 1.1. Subject demographics and history of injury (i.e., age, gender, date of injury, mechanism of injury, sports participation) 1.2. Knee range of motion, knee joint effusion, thigh circumference 1.3. Quadriceps and hamstrings strength and single leg hop testing These measures, unless otherwise indicated, will be assessed at the time of initial diagnosis, immediately prior to surgery, and at 2, 6, 12, 26, 52 and 106 weeks post-operative. 2. Biomechanical assessment – all participants will undergo three-dimensional motion analysis testing to capture the kinematics and kinetics of the lower extremities and trunk, both pre-operatively and following their six-week post-operative clinical assessment. Walking gait and landing tasks will be assessed at regular intervals from pre- to post-surgery; no landing tasks will be examined within the first 12 weeks after ACLR. All subjects must be medically cleared

Countries

United States of America

Contacts

Public ContactIsac Kunnath
isac.kunnath@osumc.edu+1 (0)6142932410

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026