Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee; Self Stimulation; Exercise Addiction

• Registration Number: NCT01320904
• Lead Sponsor: Universidade Luterana do Brasil

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Last Update Submitted: 2011-03-22
• Study First Posted: 2011-03-23
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the flexibility of the posterior chain muscles	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Evaluation of hamstring and quadriceps muscle strength	6 months	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)