Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500448
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2007-07-10
Brief Title:
An Intervention of Electrical Stimulation in Osteoarthritis
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Efficacy of Neuromuscular Electrical Stimulation for Improving Quadriceps Activation in Women With Medial Tibiofemoral Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None