OsteoarthritisPhase 2NCT01415856
Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain
A Phase 2 study testing Active Device (Torino II) in people with Osteoarthritis, run by Center for Joint Surgery and Sports Medicine, Maryland at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Active Device (Torino II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to May 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: greater than 18 years
- Weight: less than 300 lbs.
- Diagnosis: osteoarthritis
- Type of Surgery: unilateral knee replacement
Who cannot join
- No pacemaker or defibrillator.
- No infection of the affected knee.
- No previous open surgery of the affected knee.
- No history of Rheumatoid Arthritis.
- No more than 2 narcotic pills per month in the last 6 months for pain.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Joint Surgery and Sports Medicine
Hagerstown, Maryland, 21742
Ralph T Salvagno, MD, 301-665-4575
About this study
Official title: A Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Non-Invasive Pulsed Electromagnetic Fields (PEMF) on Postoperative Pain Following Total Knee Arthroplasty
The purpose of this study is to determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.
Read the detailed description
The investigators are conducting a research study to determine if the Torino II, a pulsed electromagnetic fields (PEMF) device is helpful in reducing postoperative pain and swelling after total knee replacement surgery. Postoperative pain and swelling may cause discomfort that may directly influence functional recovery after surgery. By reducing pain and swelling immediately following surgery,the use of high doses of narcotic, NSAID, and Tyelenol pain killers can be reduced, and possibly avoided. Recovery can be maximized, as well.
The PEMF device that is being used (the Torino II) is distributed by Ivivi Health Sciences, and has been approved by the FDA for the treatment of pain and swelling following surgery. The device is non-invasive, and is fixed onto the outside of the dressing with Velcro straps. The device will give off electromagnetic pulses to target pain relief in the knee. PEMF devices have been in clinical use for decades, and to date, no reported side effects have occurred.
It is important to note that treatment will still follow the standard Meritus Medical Center protocol for knee replacement surgery. This includes pain medication, icing, and physical therapy. This standard protocol will be followed no matter what study group patients are assigned to. Participation in this study or lack thereof will not change the treatment protocol.
- Conditions
- Osteoarthritis
- Being tested
- Active Device (Torino II), Sham Device (Torino II)
- Keywords
- pulsed electromagnetic fields device, Torino II, postoperative knee pain, knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Device (Torino II)Device
Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
Sham Device (Torino II)Device
Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham Device (Torino II) | Placebo comparator | Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks. Receives: Device: Sham Device (Torino II) |
| Active Device (Torino II) | Active comparator | Device is giving treatment for 15 minutes every 2 hours for a total of two weeks. Receives: Device: Active Device (Torino II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain is measured on a scale of 0-10, which is the VAS scale used by most hospitals, including Meritus Medical Center. 0 indicates no pain, while 10 indicates the worst pain possible.
Measured: 2 weeks
Edema (Swelling)
Swelling will be measured by using a disposable tape measure to measure the circumference of the patient's knee at the mid-patellar region. This will be measured in millimeters.
Measured: 2 weeks
Secondary outcomes (2)
Narcotic Pain Medications
Patients will record their use of pain and anti-inflammatory medications.
Measured: 2 weeks
Range of Motion
Patient range of motion in degrees will be measured, for flexion and extension.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Joint Surgery and Sports Medicine, Maryland
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415856
- Sponsor's protocol ID
- Salvagno 20100977
- Status last verified
- Aug 2011
- First submitted
- 10 Aug 2011
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Non-Invasive Pulsed Electromagnetic Fields (PEMF) on Postoperative Pain Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01415856
- Acronym / sponsor ID
- Salvagno 20100977
- Conditions
- Osteoarthritis
- Keywords
- pulsed electromagnetic fields device, Torino II, postoperative knee pain, knee replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Center for Joint Surgery and Sports Medicine, MarylandUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2012 (estimated)
- First posted
- 12 Aug 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 determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.
Detailed description
The investigators are conducting a research study to determine if the Torino II, a pulsed electromagnetic fields (PEMF) device is helpful in reducing postoperative pain and swelling after total knee replacement surgery. Postoperative pain and swelling may cause discomfort that may directly influence functional recovery after surgery. By reducing pain and swelling immediately following surgery,the use of high doses of narcotic, NSAID, and Tyelenol pain killers can be reduced, and possibly avoided. Recovery can be maximized, as well.
The PEMF device that is being used (the Torino II) is distributed by Ivivi Health Sciences, and has been approved by the FDA for the treatment of pain and swelling following surgery. The device is non-invasive, and is fixed onto the outside of the dressing with Velcro straps. The device will give off electromagnetic pulses to target pain relief in the knee. PEMF devices have been in clinical use for decades, and to date, no reported side effects have occurred.
It is important to note that treatment will still follow the standard Meritus Medical Center protocol for knee replacement surgery. This includes pain medication, icing, and physical therapy. This standard protocol will be followed no matter what study group patients are assigned to. Participation in this study or lack thereof will not change the treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Device (Torino II) | Placebo comparator | Device: Sham Device (Torino II)Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks. |
| Active Device (Torino II) | Active comparator | Device: Active Device (Torino II)Device is giving treatment for 15 minutes every 2 hours for a total of two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: greater than 18 years
- Weight: less than 300 lbs.
- Diagnosis: osteoarthritis
- Type of Surgery: unilateral knee replacement
Key exclusion criteria (5 listed)
- No pacemaker or defibrillator.
- No infection of the affected knee.
- No previous open surgery of the affected knee.
- No history of Rheumatoid Arthritis.
- No more than 2 narcotic pills per month in the last 6 months for pain.
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 Device (Torino II)Device is giving treatment for 15 minutes every 2 hours for a total of two weeks. | Device | Active Device (Torino II) |
| Sham Device (Torino II)Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks. | Device | Sham Device (Torino II) |
Primary outcome
Pain
Time frame: 2 weeks
Pain is measured on a scale of 0-10, which is the VAS scale used by most hospitals, including Meritus Medical Center. 0 indicates no pain, while 10 indicates the worst pain possible.
Edema (Swelling)
Time frame: 2 weeks
Swelling will be measured by using a disposable tape measure to measure the circumference of the patient's knee at the mid-patellar region. This will be measured in millimeters.
2 secondary outcomes
Narcotic Pain Medications
Time frame: 2 weeks
Range of Motion
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
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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.
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 Active Device (Torino II) in people with Osteoarthritis, run by Center for Joint Surgery and Sports Medicine, Maryland at 1 site in United States.
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 5 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 12 Aug 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 United States. 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 Ralph T Salvagno, MD (301-665-4575, ralphs@hipknee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 2 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?
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 12 Aug 2011.