Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis

NCT01320904 | Completed DMC

• 1 other identifier: MBD 275767
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis, Knee; Self Stimulation; Exercise Addiction

Keywords

Closed Kinetic Chain; NMES; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of hamstring and quadriceps muscle strength

  6 months

Study Arms (2)

Closed Kinetic Chain and NMES placebo

PLACEBO COMPARATOR

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

Closed Kinetic Chain Group

OTHER

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

Interventions

NMES PROCEDURE

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.

Also known as: 10-channel NEURODYN electrical stimulation IBRAMED

Closed Kinetic Chain and NMES placebo

Closed Kinetic Chain PROCEDURE

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.

Also known as: Closed Kinetic Chain exercises

Closed Kinetic Chain Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Luterana do Brasil: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Self Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Marcelo Dohnert

  Universidade Luterana do Brasil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 23, 2011

Record last verified: 2011-03