Osteoarthritis
Conditions
Keywords
Arthritis, Knee, Quadriceps, Electrical Stimulation, Women
Brief summary
Patients with knee osteoarthritis (OA) often have decreased thigh muscle strength. This muscle weakness is thought to originate from centers in the brain and spinal cord that restrict recruitment of fibers responsible for muscle contraction. An inability to fully contract muscles surrounding the knee joint impairs patients' abilities to perform activities of daily living (i.e. walking, climbing stairs) and may even contribute to further joint degeneration. Establishing therapies aimed at increasing muscle strength, restoring normal function, and possibly slowing the processes involved in the development of knee OA is essential in order to enhance the quality of life in the adult population plagued with this degenerative joint condition. Electrical muscle stimulation applied to the thigh is a promising therapy that has been shown to successfully restore muscle strength, however how long the treatment lasts and its influence on functional outcomes remains unknown. In order for electrical muscle stimulation to be of value it must result in sustained improvements in muscle strength and functional outcomes. Therefore, the purpose of the proposed investigation is to determine if electrical muscle stimulation can restore thigh muscle strength and improve functional outcomes in patients with knee osteoarthritis.
Detailed description
A frequent clinical obstacle encountered in patients with knee osteoarthritis (OA) is an inability to achieve full voluntary activation of the quadriceps musculature. This phenomenon has been termed arthrogenic muscle inhibition (AMI) and is an ongoing reflex inhibition of musculature surrounding a joint following distension or damage to the structures of that joint. AMI is a limiting factor in joint rehabilitation as it restricts full muscle activation and therefore prevents restoration of strength. Thus, patients often participate in life activities deficient in strength and neuromuscular control resulting in altered lower extremity mechanics and potentially predisposing patients to further joint degeneration. Neuromuscular electrical stimulation (NMES) has been shown to be successful in reversing quadriceps AMI, however the duration of its effectiveness and its influence on functional outcomes remains elusive. Therefore, the purpose of the proposed study is to examine quadriceps activation and functional outcomes following a 4-week NMES protocol in patients with medial tibiofemoral osteoarthritis. To examine the efficacy of NMES in reversing AMI and improving functional outcomes, 38 subjects will be randomly assigned to either undergo a 4-week NMES program or to undergo no therapeutic intervention. Prior to treatment and at 1, 12, and 24 weeks following treatment, patients' quadriceps central activation ratios will be assessed. Additionally, subjects will undergo gait and stair climb analyses to determine if functional performance during these activities of daily living are improved when compared to the baseline assessment. Patients' perceived level of function will also be tested using the Western Ontario and McMasters Universities Osteoarthritis Index.
Interventions
DEVICEElectrical Stimulation
Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks
Sponsors
Arthritis Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
* All participants must be female * Subjects must have radiographic osteoarthritis of grade 2 severity according to the Kellgren and Lawrence scale on the posterior-anterior semi-flexed view with definite osteophytes present in the medial and not lateral compartment.
Exclusion criteria
* Previous adverse reaction to electrical stimulation * Inability to ambulate without the use of an assistive device (i.e cane, walker) * Patients who have undergone a total knee arthroplasty * Patients who have torn any knee ligament (ACL, PCL, MCL, LCL) * Enrollees who have a demand-type cardiac pacemaker or are pregnant * History of tibial osteotomy surgery * Significant peripheral or central nervous system disease * Concurrent clinically active arthritis of the hip, ankle, hindfoot or midfoot in either limb * Concurrent bilateral radiographic evidence of tibiofemoral osteoarthritis * Enrollees who are concurrently undergoing physical therapy for pain or OA * Enrollees who are taking Cox-2 inhibitors or are receiving corticosteroid injections * Subjects will be allowed to take buffered aspirin and naproxen sodium while enrolled in the study * Enrollees who have a body mass index of greater than 40 (morbidly obese) * Enrollees who have a CAR \> .95 (e.g. patients whose quadriceps are uninhibited) * Enrollees who have previously undergone quadriceps NMES therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks | Baseline and 12 weeks post-intervention | Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus |
| Change From Baseline in Quadriceps Strength at 12 Weeks | Baseline and 12 weeks following the intervention | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC Disability Score at 12 Weeks | baseline and 12 weeks post-intervention | Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss) |
| Change From Baseline in Timed Walking Speed at 12 Weeks | Baseline and 12 weeks post-intervention | — |
| Change From Baseline in WOMAC Pain Score at 12 Weeks | Baseline and 12 weeks following intervention | WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Treatment No treatment was delivered to this arm. Participants went about activities of daily living | 14 |
| Neuromuscular Electrical Stimulation Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | No Treatment | Neuromuscular Electrical Stimulation | Total |
|---|---|---|---|
| Age, Continuous | 56.8 Years STANDARD_DEVIATION 2.9 | 58 Years STANDARD_DEVIATION 2.7 | 57.4 Years STANDARD_DEVIATION 2.8 |
| BMI | 32.1 kg^m2 STANDARD_DEVIATION 5.1 | 32.7 kg^m2 STANDARD_DEVIATION 4.1 | 32.4 kg^m2 STANDARD_DEVIATION 4.6 |
| Central Activation Ratio (CAR) | .83 ratio STANDARD_DEVIATION 0.15 | .90 ratio STANDARD_DEVIATION 0.08 | .86 ratio STANDARD_DEVIATION 0.12 |
| Height | 163.3 cm STANDARD_DEVIATION 4.5 | 162.3 cm STANDARD_DEVIATION 7.4 | 162.8 cm STANDARD_DEVIATION 5.95 |
| Mass | 87.8 kg STANDARD_DEVIATION 12.5 | 86.3 kg STANDARD_DEVIATION 13.6 | 87.05 kg STANDARD_DEVIATION 13.05 |
| Quadriceps Strength | 1.24 Nm/kg STANDARD_DEVIATION 0.35 | 1.29 Nm/kg STANDARD_DEVIATION 0.46 | 1.26 Nm/kg STANDARD_DEVIATION 0.41 |
| Region of Enrollment United States | 14 participants | 16 participants | 30 participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Timed Walking speed | 1.40 m/s STANDARD_DEVIATION 0.13 | 1.43 m/s STANDARD_DEVIATION 0.19 | 1.42 m/s STANDARD_DEVIATION 0.16 |
| WOMAC disability scale | 28.8 units on a scale (range 17-85) STANDARD_DEVIATION 15.3 | 27.1 units on a scale (range 17-85) STANDARD_DEVIATION 12.1 | 27.95 units on a scale (range 17-85) STANDARD_DEVIATION 13.7 |
| WOMAC Pain Score | 8.9 units on a scale (range 5-25) STANDARD_DEVIATION 4.3 | 7.6 units on a scale (range 5-25) STANDARD_DEVIATION 2.7 | 8.25 units on a scale (range 5-25) STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks
Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus
Time frame: Baseline and 12 weeks post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Treatment | Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks | 0.01 unitless |
| Neuromuscular Electrical Stimulation | Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks | -0.04 unitless |
Primary
Change From Baseline in Quadriceps Strength at 12 Weeks
Time frame: Baseline and 12 weeks following the intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Treatment | Change From Baseline in Quadriceps Strength at 12 Weeks | .14 Nm/kg |
| Neuromuscular Electrical Stimulation | Change From Baseline in Quadriceps Strength at 12 Weeks | -0.21 Nm/kg |
Secondary
Change From Baseline in Timed Walking Speed at 12 Weeks
Time frame: Baseline and 12 weeks post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Treatment | Change From Baseline in Timed Walking Speed at 12 Weeks | 0.04 m/s |
| Neuromuscular Electrical Stimulation | Change From Baseline in Timed Walking Speed at 12 Weeks | -0.05 m/s |
Secondary
Change From Baseline in WOMAC Disability Score at 12 Weeks
Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)
Time frame: baseline and 12 weeks post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Treatment | Change From Baseline in WOMAC Disability Score at 12 Weeks | 5.0 units on a scale |
| Neuromuscular Electrical Stimulation | Change From Baseline in WOMAC Disability Score at 12 Weeks | -4.92 units on a scale |
Secondary
Change From Baseline in WOMAC Pain Score at 12 Weeks
WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)
Time frame: Baseline and 12 weeks following intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Treatment | Change From Baseline in WOMAC Pain Score at 12 Weeks | 1.4 units on a scale |
| Neuromuscular Electrical Stimulation | Change From Baseline in WOMAC Pain Score at 12 Weeks | -0.54 units on a scale |