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Completed

NCT Number: NCT02036866

Corticospinal Excitability and Rehab in Knee Osteoarthritis

To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.

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Key information

Conditions

Knee Osteoarthritis Arthritis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Joint Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68178, United States

About this study

The primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. A secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. We hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. A 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. We further hypothesize that part of this improvement will be attributed to positive treatment expectation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19-65
  • Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at least one of the following:
  • Age > 50 years old
  • Morning stiffness < 30 minutes
  • Crepitus
  • Meet at least 3 of 6 diagnostic criteria for osteoarthritis:
  • Age > 50 years old
  • Morning stiffness < 30 minutes
  • Crepitus
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth

Exclusion criteria

  • BMI > 30
  • History of traumatic spine or lower extremity injury within the last 6 months
  • Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
  • Cardiac pacemaker
  • Metal implants in head
  • Current pregnancy
  • Neurological disorders
  • History of seizures
  • Unable to give consent or understand the procedures of this study

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation

Other

The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 8 hours per day for 1 week.

Other names: TENS, Sensory TENS

physical therapy exercises

Other

Patients will be given detailed verbal and hands-on instruction in a home exercise program. This program will consist of 6 exercises modeled from established protocols focuses on improving lower extremity strength. Patients will be instructed to do the exercises daily and to progress the exercises over the week for a maximum of 30 repetitions per day for 1 week.

No intervention

Other

Patients will be instructed to maintain their usual activity level.

Primary outcomes

  1. Change in quadriceps force output and voluntary activation

    Time frame: Baseline and following 1 week intervention (2 Study Visits)

    Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2014
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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