ClinicalTrials.Veeva

Menu

Corticospinal Excitability and Rehab in Knee Osteoarthritis

C

Creighton University

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Other: Physical Therapy Exercises
Other: No Intervention
Other: Transcutaneous Electrical Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02036866
13-16794

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

61 participants in 3 patient groups

Physical Therapy Positive Expectation
Experimental group
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.
Treatment:
Other: Transcutaneous Electrical Nerve Stimulation
Other: Physical Therapy Exercises
Physical Therapy Neutral Expectation
Experimental group
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.
Treatment:
Other: Transcutaneous Electrical Nerve Stimulation
Other: Physical Therapy Exercises
Control- No Intervention
Experimental group
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.
Treatment:
Other: No Intervention

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems