The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis

University of North Carolina (UNC)

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: Sham Transcutaneous Electrical Nerve Stimulation; Other: Therapeutic Exercise; Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02634814

15-1150

Details and patient eligibility

About

The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for the novel indication of treating neuromuscular activation in individuals with knee osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating underlying neuromuscular activation deficits. The investigators seek to use TENS to excite neural pathways that immediately increase neuromuscular activation as well as cause sustained improvements in neuromuscular activation and greater strength gains in knee OA patients compared to traditional TE. The investigators will evaluate the effect of TENS+TE on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability and pain. The central hypothesis is that an enhanced TENS+TE intervention will lead to better clinical outcomes, increased physical activity, and improved general health. The rationale for conducting a small clinical trial, which demonstrates the feasibility and establishes the preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the development of a future larger clinical trial to establish the efficacy of an enhanced rehabilitation strategy for knee OA. This hypothesis will be tested through two specific aims: 1) to collect and report data on the feasibility of conducting a clinical trial to evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a 4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self reported quality of life, disability, and pain in knee OA patients. Posttests will be at 4 and 8-weeks following baseline.

Enrollment: 90 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All knee OA participants must exhibit symptomatic knee OA, which we will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction),38 radiographic evidence of tibiofemoral OA (2-4 on the Kellgren - Lawrence scale) 39 and neuromuscular activation deficits, defined as quadriceps neuromuscular activation of less than 90% in the involved leg.3 Participants between the ages of 40 and 75 years old will be included.

Exclusion criteria

• Patients will also be excluded if they have: 1) been diagnosed with a cardiovascular condition restricting exercise; 2) had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 6-months; 3) a pacemaker; 4) a neurodegenerative condition; 5) rheumatoid arthritis; 6) cancer; 7) neural sensory dysfunction over the knee 8) a BMI over 35; 9) history of lower extremity orthopaedic surgery in the past year; 10) a history of a traumatic knee injury in the past 6 months; 11) any history of a total knee arthroplasty in either extremity; or 12) a diagnosed, non-reconstructed knee ligament tear. Patients needing an assistive device to walk and pregnant females will also be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

TENS and Therapeutic Exercise

Experimental group

Description:

Patients assigned to the TENS+Therapeutic Exercise (TE) group will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN), and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Other: Therapeutic Exercise

Sham TENS and Therapeutic Exercise

Sham Comparator group

Description:

Sham TENS+TE patients will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN) specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.

Treatment:

Other: Therapeutic Exercise

Device: Sham Transcutaneous Electrical Nerve Stimulation

Therapeutic Exercise Only

Active Comparator group

Description:

The role of the comparison group is to provide data on how traditional TE affects the outcome measures. The TE only group will allow us to assess how the addition of TENS to traditional TE will augment the effects of traditional TE. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.

Treatment:

Other: Therapeutic Exercise