Corticospinal Excitability and Rehab in Knee Osteoarthritis

NCT ID: NCT02036866

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; grade I and II knee osteoarthritis; arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Therapy Positive Expectation

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.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: 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.

Physical Therapy Exercises

Intervention Type: 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.

Physical Therapy Neutral Expectation

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.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: 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.

Physical Therapy Exercises

Intervention Type: 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.

Control- No Intervention

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.

Group Type: EXPERIMENTAL

No Intervention

Intervention Type: OTHER

Patients will be instructed to maintain their usual activity level.

Interventions

Transcutaneous Electrical Nerve Stimulation

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

Physical Therapy Exercises

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

No Intervention

Patients will be instructed to maintain their usual activity level.

Intervention Type: OTHER

Other Intervention Names

TENS; Sensory TENS

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry L Grindstaff, PhD, PT, ATC

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

13-16794

Identifier Type: -

Identifier Source: org_study_id