Corticospinal Excitability and Rehab in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Corticospinal Excitability and Rehab in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036866
• Other study ID #: 13-16794
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: December 10, 2015
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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.
• 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.
• No Intervention
Patients will be instructed to maintain their usual activity level.

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and following 1 week intervention (2 Study Visits)	No