Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-09-30

Brief Summary

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Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.

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Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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NMES

Neuromuscular electrical stimulation (NMES) group

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type DEVICE

Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.

Microstimulation

Group Type ACTIVE_COMPARATOR

Microstimulation

Intervention Type DEVICE

Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.

Interventions

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Neuromuscular electrical stimulation

Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.

Intervention Type DEVICE

Microstimulation

Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-50 yrs
* BMI \<35 kg/m2
* acute, first-time, ACL rupture with or without meniscus injury
* scheduled to undergo reconstruction with a BPTB autograft

Exclusion Criteria

* history of prior knee/lower extremity surgery or non-surgical intervention (eg, intra-articular injection) on either leg
* abnormal laxity of any lower extremity ligament other than the injured ACL
* signs or symptoms of arthritis, autoimmune or inflammatory disease or diabetes
* grade IIIb or greater articular cartilage lesions (ICRS criteria)
* women who are/plan on becoming pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No