Osteoarthritis, Knee Clinical Trial
Official title:
Neuromuscular Electrical Stimulation (NMES) on Knee Osteoarthritis(OA): an Equivalence Randomized Clinical Trial
Verified date | March 2011 |
Source | Universidade Luterana do Brasil |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.
Status | Completed |
Enrollment | 19 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - patients with grade I or grade II knee OA (based on the Kellgren-Lawrence classification; - which was diagnosed by a medical traumatologist; - radiographic changes that demonstrated a reduced joint space in at least one of the compartments of the knee; - subchondral bone sclerosis; - consent to participate in the study Exclusion Criteria: - patients who had grade III and grade IV knee OA (based on the Kellgren-Lawrence classification); - who were involved in another rehabilitation program outside the center; - who presented with clinical symptoms that would prevent them from participating in the exercises; - who had heart disease; - cardiac pacemakers; - periarticular metal implants; - who experienced changes in sensitivity; - who had a previous history of knee injury (meniscus, ligaments, sprains); - who had uncontrolled diabetes; - neurological disorders with cognitive impairments; - rheumatic diseases; - history of knee trauma in the last six months; - prior knee surgery; - three consecutive unexcused absences. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universidade Luterana do Brasil |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the flexibility of the posterior chain muscles | We only observed a significant improvement in the flexibility of the posterior muscle chain for the CKC + NMES group during the initial evaluation compared to the partial evaluation (p=0.012), the partial evaluation compared to the final evaluation (p=0.035) and the initial evaluation compared to the final evaluation (p=0.008). Regarding the scale that was used to classify the level of flexibility, 10% of the subjects in the CKC + NMES group were initially classified as good/excellent. At the end of the protocol, 60% of the subjects were classified as good/excellent (p=0.015) | 6 months | No |
Secondary | Evaluation of hamstring and quadriceps muscle strength | A significant improvement in muscle strength was only observed in the group treated with CKC + NMES. The improvement in quadriceps strength occurred during the first 10 sessions (p=0.001) Muscle strength in the hamstring muscle group responded similarly to the quadriceps muscle group (i.e., a significant improvement in muscle strength was only observed in the CKC + NMES group) in both the initial evaluation compared to the partial evaluation at 10 sessions (p=0.009) and the initial evaluation compared to the final evaluation (p=0.006) | 6 months | No |
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