Knee OsteoarthritisNCT01360281
Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis
A study testing Neuromuscular Electrical Stimulation and ECR in people with Knee Osteoarthritis, run by Universidade Gama Filho at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 38 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Neuromuscular Electrical Stimulation and ECR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Oct 2011
- 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 38 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American College of rheumatology criterion for osteoarthritis diagnosis
Who cannot join
- Patients that have done knee replacement or are about to do.
- Patients with health conditions that are not compatible with the interventions
- Patients that have done intraarticular corticoid
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinica Escola de Fisioterapia da Universidade Gama Filho
Rio de Janeiro, Rio de Janeiro
Elirez Silva, Doctor, elirezsilva@ugf.com.br
About this study
The purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Neuromuscular Electrical Stimulation, ECR
- Keywords
- Quadriceps strength, osteoarthritis rehabilitation, NMES
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationOther
ECROther
Resisted exercises
| Study group | Role | What they receive |
|---|---|---|
| ECR | Experimental | Not described Receives: Other: ECR |
| Control | No intervention | Not described |
| NMES | Experimental | Not described Receives: Other: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps strength
Measured: Before and after an 8 weeks intervention
Change in Pain
Measured: Before and after an 8 weeks intervention
Change in Moving function
Measured: Before and after an 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360281
- Sponsor's protocol ID
- CAAE00780312000-10
- Status last verified
- May 2011
- First submitted
- 19 May 2011
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01360281
- Acronym / sponsor ID
- CAAE00780312000-10
- Conditions
- Knee Osteoarthritis
- Keywords
- Quadriceps strength, osteoarthritis rehabilitation, NMES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 25 May 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.
The purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECR | Experimental | Other: ECR |
| Control | No intervention | – |
| NMES | Experimental | Other: Neuromuscular Electrical Stimulation |
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American College of rheumatology criterion for osteoarthritis diagnosis
Key exclusion criteria (3 listed)
- Patients that have done knee replacement or are about to do.
- Patients with health conditions that are not compatible with the interventions
- Patients that have done intraarticular corticoid
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 |
|---|---|---|
| Neuromuscular Electrical Stimulation | Other | NMES |
| ECRResisted exercises | Other | ECR |
Primary outcome
Change in Quadriceps strength
Time frame: Before and after an 8 weeks intervention
Change in Pain
Time frame: Before and after an 8 weeks intervention
Change in Moving function
Time frame: Before and after an 8 weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and ECR in people with Knee Osteoarthritis, run by Universidade Gama Filho 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thais Dadalto, Physical Therapist (55 21 81988001, tvdadalto@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quadriceps strength (time frame: Before and after an 8 weeks intervention). The study lists 3 primary outcomes in all. 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 25 May 2011.