Knee OsteoarthritisNCT02067871
Treatment of Knee Osteoarthritis: Neuromuscular Electrical Stimulation and Low-level Laser.
A study testing Laser Therapy and Electrical Stimulation in people with Knee Osteoarthritis, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effects of low-level laser therapy in combination with neuromuscular electrical stimulation on neuromuscular (muscular strength and morphology) and functional parameters (pain and functional tests) in elderly with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Laser Therapy and Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2012
- 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 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elderly.
- symptomatic knee osteoarthritis.
- radiographic diagnostic of Grade 2 or 3 knee osteoarthritis.
Who cannot join
- a body mass index higher than 40 Kg/m2.
- a diagnosis of hip, ankle, or toe osteoarthritis.
- the use of crutches for locomotion.
- participation in a strength-training programme or physiotherapy treatment for knee osteoarthritis in the past six months.
- neurological or cognitive disorders.
- rheumatoid arthritis.
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- electronic implants.
- previous or upcoming surgery (within three months).
- any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: Neuromuscular Electrical Stimulation and Low-level Laser: Combined Use for the Treatment of Knee Osteoarthritis in Elderly
- The purpose of this study is to determine the effects of low-level laser therapy in combination with neuromuscular electrical stimulation on neuromuscular (muscular strength and morphology) and functional parameters (pain and functional tests) in elderly with knee osteoarthritis.
- The hypothesis is that the association of low-level laser therapy with neuromuscular electrical stimulation could reduce joint pain associated with the inflammation and consequently potentiates the effects of electrical stimulation on the muscular system.
Read the detailed description
- Participants was randomized into one of three intervention groups (intervention period = 8 weeks after a 4 weeks control period in all groups).
- Electrical stimulation group (18-32 min of pulsed current, stimulation frequency of 80Hz (Hertz), pulse duration of 200μs and stimulation intensity fixed near to maximal tolerated),
- Laser group (low-level laser therapy dose of 4-6J (Joules) per point, six points at the knee joint)
- Combined group (electrical stimulation and low-level laser therapy).
- Conditions
- Knee Osteoarthritis
- Being tested
- Laser Therapy, Electrical Stimulation
- Keywords
- neuromuscular electrical stimulation, low-level laser therapy, knee osteoarthritis, muscle architecture, functionality, neuromuscular parameters
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyOther
Also called Low-Level Laser Therapy, Lasertherapy, Light therapy, Phototherapy
Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.
Electrical StimulationOther
Also called electrotherapy, electrical stimulation therapy, neuromuscular electrical stimulation
Neuromuscular electrical stimulation was administered twice a week with a minimum of 48h between sessions over a period of eight weeks and with progressive intensity and volume.
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | * 18-32 min of pulsed current.
* stimulation frequency of 80Hz (hertz).
* pulse duration of 200μs (microseconds).
* stimulation intensity fixed near to maximal tolerated. Receives: Other: Electrical Stimulation |
| Laser Therapy | Experimental | * λ = 810 nm (nanometers)
* continuous wave
* 200 mW (milliwatts) output power
* low-level laser therapy dose of 4-6J (Joules) per point
* six points at the knee joint Receives: Other: Laser Therapy |
| Combined Treatment | Experimental | Electrical Stimulation:
* 18-32 min of pulsed current,
* stimulation frequency of 80Hz (hertz).
* pulse duration of 200μs (microseconds).
* stimulation intensity fixed near to maximal tolerated.
and
Laser Therapy:
* λ = 810 nm (nanometers)
* continuous wave
* 200 mW (milliwatts) output power
* low-level laser therapy dose of 4-6J (Joules) per point.
* six points at the knee joint. Receives: Other: Laser Therapy; Other: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque change
Torque is an expression of the muscular strength and was assessed by dynamometry.
Measured: Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Secondary outcomes (1)
Muscular architecture change
Muscular architecture (muscle thickness, pennation angle and fascicle length) were assessed by ultrasonography.
Measured: Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Aurélio Vaz, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor-investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Marco A Vaz, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067871
- Sponsor's protocol ID
- UFRGS - 20160
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation and Low-level Laser: Combined Use for the Treatment of Knee Osteoarthritis in Elderly
- ClinicalTrials.gov ID
- NCT02067871
- Acronym / sponsor ID
- UFRGS - 20160
- Conditions
- Knee Osteoarthritis
- Keywords
- neuromuscular electrical stimulation, low-level laser therapy, knee osteoarthritis, muscle architecture, functionality, neuromuscular parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marco Aurélio Vaz, PhDUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Feb 2014 (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.
- The purpose of this study is to determine the effects of low-level laser therapy in combination with neuromuscular electrical stimulation on neuromuscular (muscular strength and morphology) and functional parameters (pain and functional tests) in elderly with knee osteoarthritis.
- The hypothesis is that the association of low-level laser therapy with neuromuscular electrical stimulation could reduce joint pain associated with the inflammation and consequently potentiates the effects of electrical stimulation on the muscular system.
Detailed description
- Participants was randomized into one of three intervention groups (intervention period = 8 weeks after a 4 weeks control period in all groups).
- Electrical stimulation group (18-32 min of pulsed current, stimulation frequency of 80Hz (Hertz), pulse duration of 200μs and stimulation intensity fixed near to maximal tolerated),
- Laser group (low-level laser therapy dose of 4-6J (Joules) per point, six points at the knee joint)
- Combined group (electrical stimulation and low-level laser therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Other: Electrical Stimulation* 18-32 min of pulsed current. * stimulation frequency of 80Hz (hertz). * pulse duration of 200μs (microseconds). * stimulation intensity fixed near to maximal tolerated. |
| Laser Therapy | Experimental | Other: Laser Therapy* λ = 810 nm (nanometers) * continuous wave * 200 mW (milliwatts) output power * low-level laser therapy dose of 4-6J (Joules) per point * six points at the knee joint |
| Combined Treatment | Experimental | Other: Laser Therapy, Other: Electrical StimulationElectrical Stimulation: * 18-32 min of pulsed current, * stimulation frequency of 80Hz (hertz). * pulse duration of 200μs (microseconds). * stimulation intensity fixed near to maximal tolerated. and Laser Therapy: * λ = 810 nm (nanometers) * continuous wave * 200 mW (milliwatts) output power * low-level laser therapy dose of 4-6J (Joules) per point. * six points at the knee joint. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elderly.
- symptomatic knee osteoarthritis.
- radiographic diagnostic of Grade 2 or 3 knee osteoarthritis.
Key exclusion criteria (9 listed)
- a body mass index higher than 40 Kg/m2.
- a diagnosis of hip, ankle, or toe osteoarthritis.
- the use of crutches for locomotion.
- participation in a strength-training programme or physiotherapy treatment for knee osteoarthritis in the past six months.
- neurological or cognitive disorders.
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 |
|---|---|---|
| Laser TherapyAlso: Low-Level Laser Therapy, Lasertherapy, Light therapy, PhototherapyLow-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks. | Other | Combined Treatment, Laser Therapy |
| Electrical StimulationAlso: electrotherapy, electrical stimulation therapy, neuromuscular electrical stimulationNeuromuscular electrical stimulation was administered twice a week with a minimum of 48h between sessions over a period of eight weeks and with progressive intensity and volume. | Other | Combined Treatment, Electrical stimulation |
Primary outcome
Torque change
Time frame: Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Torque is an expression of the muscular strength and was assessed by dynamometry.
1 secondary outcome
Muscular architecture change
Time frame: Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
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 20 Feb 2014.
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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.
Marco A Vaz, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy and Electrical Stimulation in people with Knee Osteoarthritis, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
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 3 inclusion and 9 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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Torque change (time frame: Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).). 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 20 Feb 2014.