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Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee, Self Stimulation, Exercise Addiction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NMES
Closed Kinetic Chain
Sponsored by
Universidade Luterana do Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Closed Kinetic Chain, NMES, Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Other

    Arm Label

    Closed Kinetic Chain and NMES placebo

    Closed Kinetic Chain Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    March 22, 2011
    Last Updated
    March 22, 2011
    Sponsor
    Universidade Luterana do Brasil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01320904
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Universidade Luterana do Brasil

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Self Stimulation, Exercise Addiction
    Keywords
    Closed Kinetic Chain, NMES, Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Closed Kinetic Chain and NMES placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Closed Kinetic Chain Group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    NMES
    Other Intervention Name(s)
    10-channel NEURODYN electrical stimulation IBRAMED
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Closed Kinetic Chain
    Other Intervention Name(s)
    Closed Kinetic Chain exercises
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evaluation of the flexibility of the posterior chain muscles
    Description
    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)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Evaluation of hamstring and quadriceps muscle strength
    Description
    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)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcelo Dohnert
    Organizational Affiliation
    Universidade Luterana do Brasil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis

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