Knee Osteoarthritis Clinical Trial
Official title:
Radiofrequency Facilitates the Prehabilitation Process in Patients Undergoing Total Knee Arthroplasty: Effects on Preoperative and Postoperative Functional Capacity. A Double Blind Randomized Controlled Trial
Verified date | August 2018 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effects of the radiofrequency applied to the
sensory innervation of the knee, with respect to a control group (standard therapy), in a
prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.
In the present study, the investigators hypothesize that participants treated with
radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the
prehabilitation program and, therefore, have a faster recovery of their functional status in
the post operative period , compared with the control group (That use the present state of
the art approach)
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Chronic knee pain, with Dynamic VAS = 5 - Scheduled for elective total knee arthroplasty - Functional impairment due to pain because of knee osteoarthritis - Taking medications to control the pain. - Ability to perform the 6 MWT. Exclusion Criteria: - ASA physical status > 3 - Morbid obesity (BMI >40) - Revision of total knee arthroplasty - Mayor neuropsychiatric disease - Mayor cardiac, renal or hepatic failure - Anemia (hematocrit <30%) - Immunosuppression - Rheumatoid arthritis - Allergy to opioids, to local anesthetics or other medications used in the study, - Chronic regular use of large doses of opioids (>20mg equivalent of morphine/day) or sedatives - Unwillingness to have spinal anesthesia - History of recent drug abuse - Contraindication to receive regional anesthesia (e.g. coagulation defect) - Inability to walk before the surgery - Inability to perform physical tasks - Contraindications to physical exercise and training - Prior mayor knee surgery - Connective tissue diseases affecting the knee - Serious neurologic disorders - Injection with steroids or hyaluronic acids during the previous 3 months - Active sciatic pain - Anticoagulant medications |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of 15% of the total distance walked during a 6MWT | change of 15% or more in total distance in six minute walk test from baseline | 18 weeks | |
Secondary | Change in WOMAC score | Change in score of WOMAC questionnaire | Baseline and 18 weeks | |
Secondary | Change in knee pain levels assessed by VAS (Dynamic/Static) | Baseline and 18 weeks | ||
Secondary | Change in amount of daily pain relief medication consumption | Baseline and 18 weeks | ||
Secondary | Change in total time of the time up and go (TUG) test | Baseline and 18 weeks |
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