Clinical trial NCT01320904: Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis
Official title: Neuromuscular Electrical Stimulation (NMES) on Knee Osteoarthritis(OA): an Equivalence Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Self Stimulation
Exercise Addiction
Keywords: Closed Kinetic Chain
NMES
Knee Osteoarthritis
Lead sponsor: Universidade Luterana do Brasil
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.

Detailed description: Abstract:

Introduction: Osteoarthritis (OA) is a degenerative and debilitating change that affects the synovial joints.

Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.

Methods: Nineteen patients with knee OA were enrolled and randomized into two groups: group I was treated with CKC + NMES, and group II was treated with CKC + NMES placebo. Both groups underwent 20 sessions of mini-squat exercises at 30 degrees of knee flexion that were associated with and interspersed with NMES for 5 minutes at a frequency of 40 hertz (Hz), 10 minutes at 70 Hz and an addition 10 minutes at 150 Hz, for a total of 25 minutes. The data were analyzed using SPSS (Statistical Package for the Social Sciences) version 17.0. Data were expressed as a frequency, mean and standard deviation and were statistically analyzed using a one-way analysis of variance (ANOVA) for repeated measurements followed by Bonferroni's post-hoc test. The investigators also used an unpaired Student's t-test and Kruskal-Wallis and Wilcoxon tests with a level of significance of P \< 0.05.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the flexibility of the posterior chain muscles
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of hamstring and quadriceps muscle strength
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Luterana do Brasil
name: Marcelo Dohnert
role: PRINCIPAL_INVESTIGATOR
References: