Unilateral Primary Osteoarthritis of KneePhase 2NCT02904785
Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis
A Phase 2 study testing Extracorporeal Shock Waves and Physical activities in people with Unilateral Primary Osteoarthritis of Knee, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Unilateral Primary Osteoarthritis of Knee
- What is being tested?
- Extracorporeal Shock Waves and Physical activities
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Dec 2016
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren \& Lawrence I, II or III);
- Capability to understand the Informed Consent Form;
- Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
- Absence of skin injures, infections or tumor in the target knee;
- Availability to comply with the visits.
Who cannot join
- History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
- History or onset neurological diseases;
- Generalized pain or fibromyalgia;
- Inability to walk;
- History of knee surgery in the target knee;
- Secondary causes of osteoarthritis;
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- Use of statins and quinolones in the previous year;
- Uncontrolled and ongoing psychiatric diseases;
- Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
São Paulo, São Paulo, 04116-030
Fabíola Cavalieri, MD, 55-11-99212-3999, fabiola.cavalieri@hc.fm.usp.br
Artur C Santos, 55-11-5180-7897, artur.santos@hc.fm.usp.br
About this study
Official title: The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.
Read the detailed description
This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).
The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.
The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.
- Being tested
- Extracorporeal Shock Waves, Sham Extracorporeal Shock Waves, Physical activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock WavesDevice
Sham Extracorporeal Shock WavesDevice
Physical activitiesOther
Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Waves | Experimental | Focused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. Receives: Device: Extracorporeal Shock Waves; Other: Physical activities |
| Sham Extracorporeal Shock Waves | Sham comparator | Sham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered. Receives: Device: Sham Extracorporeal Shock Waves; Other: Physical activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain after one month
Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
Measured: One month
Secondary outcomes (8)
Knee pain progression
Mean change in VAS score one week after each application compared to baseline.
Measured: One week after each of four weekly ESWT applications
Knee Pain after three months
Mean change in VAS score three months after the end of the treatment compared to baseline.
Measured: Three months
Lequesne Knee Function progression
Mean change in Lequesne score one week after each application compared to baseline.
Measured: One week after each of four weekly ESWT applications
Lequesne Knee Function after three months
Mean change in Lequesne three months after the end of the treatment compared to baseline.
Measured: Three months
WOMAC Knee Function progression
Mean change in WOMAC score one week after each application compared to baseline.
Measured: One week after each of four weekly ESWT applications
TUG Knee Function progression
Mean change in TUG score one week after each application compared to baseline.
Measured: One week after each of four weekly ESWT applications
WOMAC Knee Function after three months
Mean change in WOMAC score three months after the end of the treatment compared to baseline.
Measured: Three months
TUG Knee Function after three months
Mean change in TUG score three months after the end of the treatment compared to baseline.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital
- Investigators
- Linamara R Battistella, PhD, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904785
- Sponsor's protocol ID
- 54013616.1.0000.0068
- Status last verified
- Sep 2016
- First submitted
- 29 Jun 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Extracorporeal Focused Shock Wave Therapy for Patients With Primary Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02904785
- Acronym / sponsor ID
- 54013616.1.0000.0068
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 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.
The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.
Detailed description
This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).
The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.
The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Waves | Experimental | Device: Extracorporeal Shock Waves, Other: Physical activitiesFocused shock waves delivered by an electromagnetic generator with a focus of 5.0cm deep on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. |
| Sham Extracorporeal Shock Waves | Sham comparator | Device: Sham Extracorporeal Shock Waves, Other: Physical activitiesSham focused shock waves delivered by an electromagnetic generator on the affected knee in three different positions. A total of 7000 pulses will be delivered on a weekly session for four weeks. A foam will be placed in the probe as to stop the energy to be transmitted to the patient's knee, so no focused shockwaves will be delivered. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren \& Lawrence I, II or III);
- Capability to understand the Informed Consent Form;
- Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
- Absence of skin injures, infections or tumor in the target knee;
- Availability to comply with the visits.
Key exclusion criteria (9 listed)
- History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
- History or onset neurological diseases;
- Generalized pain or fibromyalgia;
- Inability to walk;
- History of knee surgery in the target knee;
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 |
|---|---|---|
| Extracorporeal Shock Waves | Device | Extracorporeal Shock Waves |
| Sham Extracorporeal Shock Waves | Device | Sham Extracorporeal Shock Waves |
| Physical activitiesPatients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles. | Other | Extracorporeal Shock Waves, Sham Extracorporeal Shock Waves |
Primary outcome
Knee Pain after one month
Time frame: One month
Mean change in Visual Analogue Scale (VAS) score one month after the end of the treatment compared to baseline.
8 secondary outcomes
Knee pain progression
Time frame: One week after each of four weekly ESWT applications
Knee Pain after three months
Time frame: Three months
Lequesne Knee Function progression
Time frame: One week after each of four weekly ESWT applications
Lequesne Knee Function after three months
Time frame: Three months
WOMAC Knee Function progression
Time frame: One week after each of four weekly ESWT applications
TUG Knee Function progression
Time frame: One week after each of four weekly ESWT applications
WOMAC Knee Function after three months
Time frame: Three months
TUG Knee Function after three months
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- 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.
Linamara R Battistella, PhD, MD principal investigator
University of Sao Paulo
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 Extracorporeal Shock Waves and Physical activities in people with Unilateral Primary Osteoarthritis of Knee, run by University of Sao Paulo General Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilson T Shinzato, MD (55-11-99688-0698, g.shinzato@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain after one month (time frame: One month). 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 19 Sep 2016.