Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Universidade Luterana do Brasil
ClinicalTrials.gov Identifier:
NCT01320904
First received: March 22, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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


Condition Intervention
Osteoarthritis, Knee
Self Stimulation
Exercise Addiction
Procedure: NMES
Procedure: Closed Kinetic Chain

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation (NMES) on Knee Osteoarthritis(OA): an Equivalence Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade Luterana do Brasil:

Primary Outcome Measures:
  • Evaluation of the flexibility of the posterior chain muscles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Evaluation of hamstring and quadriceps muscle strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 19
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Closed Kinetic Chain and NMES placebo

During the stimulation period the patient remained in a mini-squat position at thirty degrees and returned to zero degrees during the decay period. During the electrical stimulation off period, the patient spontaneously performed another mini-squat at 30 degrees without electrical stimulation. The patients in the CKC + NMES placebo group simulated the same work applied to the NMES group. Notably, this group was also connected to the electrodes, but the equipment was set at a stimulus intensity of zero.

We used a 10-channel electrical stimulation device with a 2500-Hz carrier frequency. We used four channels in the synchronous mode, with surface electrodes that were simultaneously fixed at the motor points of the quadriceps and hamstrings.

Procedure: NMES

We used a electrical stimulation device with a 2500-Hz carrier frequency. We used four channels in the synchronous mode, with surface electrodes that were simultaneously fixed at the motor points of the quadriceps and hamstrings. Initially, a warm-up protocol that was five minutes long was used at a stimulation frequency of 40 Hz to activate the slow fibers. These fibers activated with a four-second-contraction time (on), a four-second-stimulus rise time, a four-second-stimulation decay time and a 12-second relaxation time (off).

We then increased the frequency to 70 Hz to activate the fast fibers for an additional 10 minutes using the parameters described above, and finally, the frequency was increase to 150 Hz for 10 minutes to achieve maximal muscle potentiation.

Other Name: 10-channel NEURODYN electrical stimulation IBRAMED
Closed Kinetic Chain Group
During the stimulation period, i.e., the on time, the patient remained in a mini-squat position at thirty degrees and returned to zero degrees during the decay period. During the electrical stimulation off period, the patient spontaneously performed another mini-squat at 30 degrees without electrical stimulation. The patients in the CKC + NMES placebo group simulated the same work applied to the NMES group. Notably, this group was also connected to the electrodes, but the equipment was set at a stimulus intensity of zero.
Procedure: Closed Kinetic Chain
During the stimulation period, i.e., the on time, the patient remained in a mini-squat position at thirty degrees and returned to zero degrees during the decay period. During the electrical stimulation off period, the patient spontaneously performed another mini-squat at 30 degrees without electrical stimulation. The patients in the CKC + NMES placebo group simulated the same work applied to the NMES group. Notably, this group was also connected to the electrodes, but the equipment was set at a stimulus intensity of zero.
Other Name: Closed Kinetic Chain exercises

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01320904

Sponsors and Collaborators
Universidade Luterana do Brasil
Investigators
Principal Investigator: Marcelo Dohnert Universidade Luterana do Brasil
  More Information

No publications provided

Responsible Party: Marcelo Baptista Dohnert, Universidade Luterana do Brasil
ClinicalTrials.gov Identifier: NCT01320904     History of Changes
Other Study ID Numbers: MBD 275767
Study First Received: March 22, 2011
Last Updated: March 22, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Luterana do Brasil:
Closed Kinetic Chain
NMES
Knee Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014