OsteoarthritisNCT02898025
Low Level Laser Therapy and Interferential Current in Osteoarthritis
A study testing Active Interferential Current and Active Laser in people with Osteoarthritis, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Active Interferential Current and Active Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Aug 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of osteoarthritis of the knee characterized by pain of mild or moderate intensity
- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
- Patients with knee osteoarthritis (s) according to the ACR criteria
- VAS 3 to 8
- 5 to 12 Lequesne
- No complaint of pain in other joints of the lower limbs
Show all 12Show fewer
- Without neurological and cognitive disorders
- No loss of sensation in the lower limbs
- No surgery on the knee (s) in the last 6 months
- Pain symptoms for at least 6 months
- No infiltrations (s) knee (s) in the last 4 weeks
- No use of analgesics 4 hours before treatment
Who cannot join
- Individuals younger than 18 and older than 80 years
- Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial
This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis
Read the detailed description
Interventional
- Conditions
- Osteoarthritis
- Being tested
- Active Interferential Current, Active Laser, Placebo Interferential Current, Placebo Laser
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Interferential CurrentDevice
Also called interferential therapy, IFC
Involves the application of medium frequency alternating currents
Active LaserDevice
Also called low level laser therapy
Involves the application of low level laser over the knee
Placebo Interferential CurrentDevice
It is a sham interferential therapy
Placebo LaserDevice
It is a sham laser therapy
| Study group | Role | What they receive |
|---|---|---|
| G1 (Active IFC and Active Laser) | Active comparator | 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G1) will receive the treatment of Active Interferential Current and Active Laser for 12 sessions. Receives: Device: Active Interferential Current; Device: Active Laser |
| G2 (Active IFC and Placebo Laser) | Active comparator | 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G2) will receive the treatment of Active Interferential Current and Placebo Laser for 12 sessions. Receives: Device: Active Interferential Current; Device: Placebo Laser |
| G3 (Placebo IFC and Active Laser) | Active comparator | 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G3) will receive Placebo Interferential Current and Active Laser for 12 sessions. Receives: Device: Active Laser; Device: Placebo Interferential Current |
| G4 (Placebo IFC and Placebo Laser) | Placebo comparator | 42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. The placebo group (G4) will receive Placebo Interferential Current and Placebo Laser for 12 sessions. Receives: Device: Placebo Interferential Current; Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by a numeric pain scale ranging from 0 to 10.
Measured: 4 weeks
Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.
Measured: 4 weeks
Secondary outcomes (4)
TUG (Timed Up & Go Test)
Measured: Measure at baseline, 4 weeks, 3 months, 6 months
Isokinetic Muscle Assessment
Measured: Measure at baseline, 4 weeks, 3 months, 6 months
LeQuesne Questionnaire
Measured: Measure at baseline, 4 weeks, 3 months, 6 months
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Measured: Measure at baseline, 4 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Eloin Liebano, Universidade Cidade de Sao Paulo
- Investigators
- Richard E Liebano, PhD, Principal investigator, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898025
- Sponsor's protocol ID
- RLiebano
- Status last verified
- Oct 2017
- First submitted
- 20 Apr 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.
PubMed 29722602
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02898025
- Acronym / sponsor ID
- RLiebano
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Sep 2016 (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.
This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis
Detailed description
Interventional
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1 (Active IFC and Active Laser) | Active comparator | Device: Active Interferential Current, Device: Active Laser42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G1) will receive the treatment of Active Interferential Current and Active Laser for 12 sessions. |
| G2 (Active IFC and Placebo Laser) | Active comparator | Device: Active Interferential Current, Device: Placebo Laser42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G2) will receive the treatment of Active Interferential Current and Placebo Laser for 12 sessions. |
| G3 (Placebo IFC and Active Laser) | Active comparator | Device: Active Laser, Device: Placebo Interferential Current42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G3) will receive Placebo Interferential Current and Active Laser for 12 sessions. |
| G4 (Placebo IFC and Placebo Laser) | Placebo comparator | Device: Placebo Interferential Current, Device: Placebo Laser42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. The placebo group (G4) will receive Placebo Interferential Current and Placebo Laser for 12 sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- History of osteoarthritis of the knee characterized by pain of mild or moderate intensity
- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
- Patients with knee osteoarthritis (s) according to the ACR criteria
- VAS 3 to 8
- 5 to 12 Lequesne
Key exclusion criteria (2 listed)
- Individuals younger than 18 and older than 80 years
- Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry
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 |
|---|---|---|
| Active Interferential CurrentAlso: interferential therapy, IFCInvolves the application of medium frequency alternating currents | Device | G1 (Active IFC and Active Laser), G2 (Active IFC and Placebo Laser) |
| Active LaserAlso: low level laser therapyInvolves the application of low level laser over the knee | Device | G1 (Active IFC and Active Laser), G3 (Placebo IFC and Active Laser) |
| Placebo Interferential CurrentIt is a sham interferential therapy | Device | G3 (Placebo IFC and Active Laser), G4 (Placebo IFC and Placebo Laser) |
| Placebo LaserIt is a sham laser therapy | Device | G2 (Active IFC and Placebo Laser), G4 (Placebo IFC and Placebo Laser) |
Primary outcome
Pain intensity measured by a numeric pain scale ranging from 0 to 10.
Time frame: 4 weeks
Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.
Time frame: 4 weeks
4 secondary outcomes
TUG (Timed Up & Go Test)
Time frame: Measure at baseline, 4 weeks, 3 months, 6 months
Isokinetic Muscle Assessment
Time frame: Measure at baseline, 4 weeks, 3 months, 6 months
LeQuesne Questionnaire
Time frame: Measure at baseline, 4 weeks, 3 months, 6 months
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Time frame: Measure at baseline, 4 weeks, 3 months, 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 25 Oct 2017.
- Derived from this study: PubMed 29722602Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.
- Individual participant dataSharing planned: Undecided
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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.
Richard E Liebano, PhD principal investigator
Universidade Cidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Interferential Current and Active Laser in people with Osteoarthritis, run by Universidade Cidade de Sao Paulo 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 12 inclusion and 2 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 25 Oct 2017. 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. 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?
Pain intensity measured by a numeric pain scale ranging from 0 to 10. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898025, which also lists 1 linked publication.
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 Oct 2017.