Osteoarthritis, KneeNCT01320904
Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis
A study testing NMES and Closed Kinetic Chain in people with Osteoarthritis, Knee and Self Stimulation, run by Universidade Luterana do Brasil.
Trial summary
Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Self Stimulation, Exercise Addiction
- What is being tested?
- NMES and Closed Kinetic Chain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
About this study
Official title: Neuromuscular Electrical Stimulation (NMES) on Knee Osteoarthritis(OA): an Equivalence Randomized Clinical Trial
Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Self Stimulation, Exercise Addiction
- Being tested
- NMES, Closed Kinetic Chain
- Keywords
- Closed Kinetic Chain, NMES, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Self Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESProcedure or surgery
Also called 10-channel NEURODYN electrical stimulation IBRAMED
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.
Closed Kinetic ChainProcedure or surgery
Also called Closed Kinetic Chain exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Closed Kinetic Chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Luterana do Brasil
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo Dohnert, Principal investigator, Universidade Luterana do Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320904
- Sponsor's protocol ID
- MBD 275767
- Status last verified
- Mar 2011
- First submitted
- 22 Mar 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation (NMES) on Knee Osteoarthritis(OA): an Equivalence Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01320904
- Acronym / sponsor ID
- MBD 275767
- Conditions
- Osteoarthritis, Knee, Self Stimulation, Exercise Addiction
- Keywords
- Closed Kinetic Chain, NMES, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidade Luterana do BrasilUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Kinetic Chain and NMES placebo | Placebo comparator | Procedure: NMESDuring 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. |
| Closed Kinetic Chain Group | Other | Procedure: Closed Kinetic ChainDuring 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESAlso: 10-channel NEURODYN electrical stimulation IBRAMEDWe 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. | Procedure or surgery | Closed Kinetic Chain and NMES placebo |
| Closed Kinetic ChainAlso: Closed Kinetic Chain exercisesDuring 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 or surgery | Closed Kinetic Chain Group |
Primary outcome
Evaluation of the flexibility of the posterior chain muscles
Time frame: 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)
1 secondary outcome
Evaluation of hamstring and quadriceps muscle strength
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Dohnert principal investigator
Universidade Luterana do Brasil
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Closed Kinetic Chain in people with Osteoarthritis, Knee and Self Stimulation, run by Universidade Luterana do Brasil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the flexibility of the posterior chain muscles (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.