Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184451
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-12-14
Brief Title:
Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis Controlled Randomized and Blinded Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups 1 Therapeutic Exercises Transcutaneous electrical nerve stimulation and 2 Therapeutic Exercises placebo Transcutaneous electrical nerve stimulation
Therefore individuals of both sexes aged 40 years or over with a clinical diagnosis of unilateral osteoarthritis of the knee who present with knee pain for more than three months morning stiffness for less than 30 minutes crepitus bone sensitivity and absence of palpable heat and diagnosis established radiographically determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4
Exclusion criteria are bilateral knee Osteoarthritis hip Osteoarthritis severe osteoporosis fibromyalgia clinical history of tumors or cancer active inflammatory joint diseases rheumatoid arthritis gout undergoing any lower extremity joint replacement neurological disorders Parkinsons disease stroke multiple sclerosis muscular dystrophies motor neuron disease Alzheimers disease infected wounds or osteomyelitis in the knee region deep vein thrombosis or thrombophlebitis sensory changes in the lower limbs cognitive impairment and cardiopulmonary disorders that may prevent or limit the execution of exercises use of a walking assistance device history of recent trauma to the knee having undergone any form of treatment involving physiotherapy intra-articular corticosteroids anti-inflammatories or chondroprotective within the six months before the start of interventions
Therefore individuals of both sexes aged 40 years or over with a clinical diagnosis of unilateral osteoarthritis of the knee who present with knee pain for more than three months morning stiffness for less than 30 minutes crepitus bone sensitivity and absence of palpable heat and diagnosis established radiographically determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4
Exclusion criteria are bilateral knee Osteoarthritis hip Osteoarthritis severe osteoporosis fibromyalgia clinical history of tumors or cancer active inflammatory joint diseases rheumatoid arthritis gout undergoing any lower extremity joint replacement neurological disorders Parkinsons disease stroke multiple sclerosis muscular dystrophies motor neuron disease Alzheimers disease infected wounds or osteomyelitis in the knee region deep vein thrombosis or thrombophlebitis sensory changes in the lower limbs cognitive impairment and cardiopulmonary disorders that may prevent or limit the execution of exercises use of a walking assistance device history of recent trauma to the knee having undergone any form of treatment involving physiotherapy intra-articular corticosteroids anti-inflammatories or chondroprotective within the six months before the start of interventions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None