Corticospinal Excitability and Rehab in Knee Osteoarthritis

NCT02036866 | Completed

• 1 other identifier: 13-16794
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; grade I and II knee osteoarthritis; arthritis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Physical Therapy Positive Expectation

EXPERIMENTAL

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.

Other: Transcutaneous Electrical Nerve Stimulation; Other: Physical Therapy Exercises

Physical Therapy Neutral Expectation

EXPERIMENTAL

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.

Other: Transcutaneous Electrical Nerve Stimulation; Other: Physical Therapy Exercises

Control- No Intervention

EXPERIMENTAL

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.

Other: No Intervention

Interventions

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.

Also known as: TENS, Sensory TENS

Physical Therapy Neutral Expectation; Physical Therapy Positive Expectation

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.

Physical Therapy Neutral Expectation; Physical Therapy Positive Expectation

No Intervention OTHER

Patients will be instructed to maintain their usual activity level.

Control- No Intervention

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Lymphoma, Follicular; Arthritis

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Terry L Grindstaff, PhD, PT, ATC

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)