OsteoarthritisPhase 2NCT02154893
Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality
A Phase 2 study testing Ultrasound plus Laser and therapeutic exercise and Ultrasound plus Laser in people with Osteoarthritis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ultrasound plus Laser and therapeutic exercise and Ultrasound plus Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to May 2014
- Phase
- Phase 2
- 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
- Caucasian women
- Aged between 60 and 80 years
- Hand osteoarthritis
- Knee osteoarthritis
Who cannot join
- Psychiatric disorder,
- Neurological disease
- Metabolic disease
- Pulmonary disease
- Cardiac disease,
- Thrombosis
- Cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality in Women With Hand or Knee Osteoarthritis.
There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. The investigators hypothesis was that a combination of US, LLLT and therapeutic exercise may maximize clinical outcome.
Read the detailed description
Patients with pain, especially chronic pain, avoid movements. This is turn results in a gradual impairment of their physical condition, reducing, for example, strength, flexibility, physical functionality and occupational activity. To performed physical treatments, a prototype device was development. The device includes four diode laser beams (808 nm) around of the one ultrasound transducer.
- Conditions
- Osteoarthritis
- Being tested
- Ultrasound plus Laser and therapeutic exercise, Ultrasound plus Laser, Utrasound plus Laser Placebo
- Keywords
- Ultrasound, Laser, Therapeutic exercise, Rehabilitation, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound plus Laser and therapeutic exerciseDevice
Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months.
Ultrasound plus LaserDevice
Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.
Utrasound plus Laser PlaceboDevice
The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).
| Study group | Role | What they receive |
|---|---|---|
| Device and exercise | Experimental | Device with ultrasound and laser associated with therapeutic exercise Receives: Device: Ultrasound plus Laser and therapeutic exercise |
| Device | Experimental | Device with ultrasound and laser Receives: Device: Ultrasound plus Laser |
| Placebo | Placebo comparator | Without any treatment Receives: Device: Utrasound plus Laser Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pain for hands and knees
Pressure pain thresholds by algometry (N)
Measured: 3 months
Secondary outcomes (12)
Subjective pain scale for hands and knees
Pain intensity by visual analog scale (VAS)
Measured: 3 months
Jebsen-Taylor Hand Function Test
The time (s) to perform different activities is registered
Measured: 3 months
Box and block Hand Function Test
The number of wooden blocks that can be transported from one compartement of a box to another within 1 min is counted
Measured: 3 months
Toe-Touching Function Test
The distance (cm) from the finger of hand to finger of foot is registered
Measured: 3 months
Sit-to-Stand Function Test
The number of sit-to-stand within 1 min is counted
Measured: 3 months
Gait Function Test
The time (s) to perform 10 meters walked is registered
Measured: 3 months
Balance Function Test
The time (s) to perform static and dynamic balance is registered
Measured: 3 months
Dynamometry
Strength (N)
Measured: 3 months
Accelerometer
Acceleration (km.h-1)
Measured: 3 months
Electrogoniometry
Range of motion (angle)
Measured: 3 months
Quality of life Questionnaire
SF36
Measured: 3 months
Questionnaire for Osteoarthritis
AUSCAN, WOMAC, KOOS, LEQUESNE index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Fernanda Rossi Paolillo, University of Sao Paulo
- Investigators
- Vanderlei S Bagnato, Ph.D, Study director, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Alessandra R Paolillo, Ph.D, Study director, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Fernanda R Paolillo, Ph.D, Principal investigator, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Jéssica João, PT, Principal investigator, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Herbert João, Msc, Principal investigator, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154893
- Sponsor's protocol ID
- FAPESP2013
- Status last verified
- May 2014
- First submitted
- 24 May 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brosseau L, Wells G, Marchand S, Gaboury I, Stokes B, Morin M, Casimiro L, Yonge K, Tugwell P. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005 Mar;36(3):210-9. doi: 10.1002/lsm.20137.
PubMed 15704096Ekim A, Armagan O, Tascioglu F, Oner C, Colak M. Effect of low level laser therapy in rheumatoid arthritis patients with carpal tunnel syndrome. Swiss Med Wkly. 2007 Jun 16;137(23-24):347-52. doi: 10.4414/smw.2007.11581.
PubMed 17629805Allen RJ. Physical agents used in the management of chronic pain by physical therapists. Phys Med Rehabil Clin N Am. 2006 May;17(2):315-45. doi: 10.1016/j.pmr.2005.12.007.
PubMed 16616270Korstjens CM, van der Rijt RH, Albers GH, Semeins CM, Klein-Nulend J. Low-intensity pulsed ultrasound affects human articular chondrocytes in vitro. Med Biol Eng Comput. 2008 Dec;46(12):1263-70. doi: 10.1007/s11517-008-0409-9. Epub 2008 Oct 14.
PubMed 18853213Tascioglu F, Kuzgun S, Armagan O, Ogutler G. Short-term effectiveness of ultrasound therapy in knee osteoarthritis. J Int Med Res. 2010 Jul-Aug;38(4):1233-42. doi: 10.1177/147323001003800404.
PubMed 20925995
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality in Women With Hand or Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT02154893
- Acronym / sponsor ID
- FAPESP2013
- Conditions
- Osteoarthritis
- Keywords
- Ultrasound, Laser, Therapeutic exercise, Rehabilitation, Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Jun 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.
There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. The investigators hypothesis was that a combination of US, LLLT and therapeutic exercise may maximize clinical outcome.
Detailed description
Patients with pain, especially chronic pain, avoid movements. This is turn results in a gradual impairment of their physical condition, reducing, for example, strength, flexibility, physical functionality and occupational activity. To performed physical treatments, a prototype device was development. The device includes four diode laser beams (808 nm) around of the one ultrasound transducer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Device and exercise | Experimental | Device: Ultrasound plus Laser and therapeutic exerciseDevice with ultrasound and laser associated with therapeutic exercise |
| Device | Experimental | Device: Ultrasound plus LaserDevice with ultrasound and laser |
| Placebo | Placebo comparator | Device: Utrasound plus Laser PlaceboWithout any treatment |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian women
- Aged between 60 and 80 years
- Hand osteoarthritis
- Knee osteoarthritis
Key exclusion criteria (7 listed)
- Psychiatric disorder,
- Neurological disease
- Metabolic disease
- Pulmonary disease
- Cardiac disease,
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 |
|---|---|---|
| Ultrasound plus Laser and therapeutic exerciseUltrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months. | Device | Device and exercise |
| Ultrasound plus LaserUltrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months. | Device | Device |
| Utrasound plus Laser PlaceboThe device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose). | Device | Placebo |
Primary outcome
Analysis of pain for hands and knees
Time frame: 3 months
Pressure pain thresholds by algometry (N)
12 secondary outcomes
Subjective pain scale for hands and knees
Time frame: 3 months
Jebsen-Taylor Hand Function Test
Time frame: 3 months
Box and block Hand Function Test
Time frame: 3 months
Toe-Touching Function Test
Time frame: 3 months
Sit-to-Stand Function Test
Time frame: 3 months
Gait Function Test
Time frame: 3 months
Balance Function Test
Time frame: 3 months
Dynamometry
Time frame: 3 months
Accelerometer
Time frame: 3 months
Electrogoniometry
Time frame: 3 months
Quality of life Questionnaire
Time frame: 3 months
Questionnaire for Osteoarthritis
Time frame: 3 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 4 Dec 2015.
- Results publication: PubMed 15704096Brosseau L, Wells G, Marchand S, Gaboury I, Stokes B, Morin M, Casimiro L, Yonge K, Tugwell P. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005 Mar;36(3):210-9. doi: 10.1002/lsm.20137.
- Results publication: PubMed 17629805Ekim A, Armagan O, Tascioglu F, Oner C, Colak M. Effect of low level laser therapy in rheumatoid arthritis patients with carpal tunnel syndrome. Swiss Med Wkly. 2007 Jun 16;137(23-24):347-52. doi: 10.4414/smw.2007.11581.
- Results publication: PubMed 16616270Allen RJ. Physical agents used in the management of chronic pain by physical therapists. Phys Med Rehabil Clin N Am. 2006 May;17(2):315-45. doi: 10.1016/j.pmr.2005.12.007.
- Results publication: PubMed 18853213Korstjens CM, van der Rijt RH, Albers GH, Semeins CM, Klein-Nulend J. Low-intensity pulsed ultrasound affects human articular chondrocytes in vitro. Med Biol Eng Comput. 2008 Dec;46(12):1263-70. doi: 10.1007/s11517-008-0409-9. Epub 2008 Oct 14.
- Results publication: PubMed 20925995Tascioglu F, Kuzgun S, Armagan O, Ogutler G. Short-term effectiveness of ultrasound therapy in knee osteoarthritis. J Int Med Res. 2010 Jul-Aug;38(4):1233-42. doi: 10.1177/147323001003800404.
- Optics and Photonics Research CenterLink provided by the sponsor.
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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.
Vanderlei S Bagnato, Ph.D study director
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Alessandra R Paolillo, Ph.D study director
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Fernanda R Paolillo, Ph.D principal investigator
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasound plus Laser and therapeutic exercise and Ultrasound plus Laser in people with Osteoarthritis, run by University of 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 4 inclusion and 7 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 4 Dec 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Analysis of pain for hands and knees (time frame: 3 months). 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 NCT02154893, which also lists 5 linked publications.
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 4 Dec 2015.