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Corticospinal Excitability and Rehab in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation
Physical Therapy Exercises
No Intervention
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, grade I and II knee osteoarthritis, arthritis

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Physical Therapy Positive Expectation

Physical Therapy Neutral Expectation

Control- No Intervention

Arm Description

The physical therapist will read a script indicating that the intervention is an effective treatment for knee osteoarthritis and is expected to reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS (transcutaneous electrical nerve stimulation) unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily.

The physical therapist will read a script indicating that the intervention may or may not be an effective treatment for knee osteoarthritis and may nor may not reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily.

The patients in the control group will be reminded of their appointment in 1 week and instructed to maintain their usual activity level during that time.

Outcomes

Primary Outcome Measures

Change in quadriceps force output and voluntary activation
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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2014
Last Updated
December 10, 2015
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT02036866
Brief Title
Corticospinal Excitability and Rehab in Knee Osteoarthritis
Official Title
Corticospinal Excitability and Rehab in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, grade I and II knee osteoarthritis, arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy Positive Expectation
Arm Type
Experimental
Arm Description
The physical therapist will read a script indicating that the intervention is an effective treatment for knee osteoarthritis and is expected to reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS (transcutaneous electrical nerve stimulation) unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily.
Arm Title
Physical Therapy Neutral Expectation
Arm Type
Experimental
Arm Description
The physical therapist will read a script indicating that the intervention may or may not be an effective treatment for knee osteoarthritis and may nor may not reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily.
Arm Title
Control- No Intervention
Arm Type
Experimental
Arm Description
The patients in the control group will be reminded of their appointment in 1 week and instructed to maintain their usual activity level during that time.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS, Sensory TENS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
Patients will be instructed to maintain their usual activity level.
Primary Outcome Measure Information:
Title
Change in quadriceps force output and voluntary activation
Description
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.
Time Frame
Baseline and following 1 week intervention (2 Study Visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry L Grindstaff, PhD, PT, ATC
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States

12. IPD Sharing Statement

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Corticospinal Excitability and Rehab in Knee Osteoarthritis

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