Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persists for years despite rehabilitation, hindering resumption of normal activities, increasing the risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). The period from the injury through the early, post-surgical period is critical for the development of functional deficits, as the trauma of the injury and surgery combine with muscle disuse to reduce skeletal muscle size and intrinsic function.

This study aims 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. Early intervention and prevention of these muscle adaptations will lead to improved muscle function and, over the longer-term, a reduced risk for further injury and the development of OA, as well as improved patient-reported outcomes and satisfaction with treatment. While NMES is used clinically to enhance neural activation and contractile responses to strengthening exercises during standard rehabilitation, its utility as a singular modality during the post-injury and early, post-surgical period to prevent intrinsic muscle morphological and functional adaptations has never been evaluated. Based on the preliminary data, this study hypothesizes that early institution of NMES will prevent or diminish skeletal muscle fiber atrophy and contractile dysfunction and, in turn, improve whole muscle function at short-term follow-up.

ELIGIBILITY CRITERIA:

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

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Prevention

Study Location(s):

University of Vermont College of Medicine, Burlington, Vermont, United States, 05405

Study Website:

https://clinicaltrials.gov/ct2/show/NCT02945553?term=NCT02945553&rank=1

Last Reviewed: 05/06/2019