Knee OsteoarthritisNCT01877278
Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial
A study testing Wearable pulsed electromagnetic fields in people with Knee Osteoarthritis, run by University of Messina at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Wearable pulsed electromagnetic fields
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of primary OA of the knee according to the ACR criteria, including radiologic evidence of OA
- age >40 years
- symptomatic disease for at least 6 months prior to enrollment
- persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (NSAID), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (VAS) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
- ability to attend followup appointments
Who cannot join
- secondary causes of OA
- local or systemic infection
- diabetes mellitus
- systemic arthritis
- allergy to anesthetic agent or contrast material
- coagulopathy
Show all 10Show fewer
- anticoagulant therapy
- had previous IA steroid injection
- avascular necrosis of bone
- patients who are on specific OA pharmacological therapy (NSAIDS, opioids) for more than 2 weeks prior enrollment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino
Messina, Messina, 98100
About this study
Official title: Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial
The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.
- Conditions
- Knee Osteoarthritis
- Being tested
- Wearable pulsed electromagnetic fields
- Keywords
- Osteoarthritis, Pulsed electromagnetic fields, Device, Pain, Pressure algometry
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable pulsed electromagnetic fieldsDevice
Also called actipatch
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | Group wearing the active device emitting pulsed electromagnetic fileds Receives: Device: Wearable pulsed electromagnetic fields |
| placebo | Placebo comparator | Group wearing the device non-emitting pulsed electromagnetic fileds Receives: Device: Wearable pulsed electromagnetic fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)
Measured: baseline and 4 weeks
Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4
Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis.
The WOMAC consists of 24 items divided into 3 subscales:
Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfilippo Bagnato, University of Messina
- Investigators
- Gianfilippo Bagnato, Professor, Study chair, University of MessinaGianfilippo Bagnato, MD, Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877278
- Sponsor's protocol ID
- 11262
- Status last verified
- Jan 2015
- First submitted
- 11 Jun 2013
- Last updated
- 9 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Trock DH, Bollet AJ, Dyer RH Jr, Fielding LP, Miner WK, Markoll R. A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. J Rheumatol. 1993 Mar;20(3):456-60.
PubMed 8478852Thamsborg G, Florescu A, Oturai P, Fallentin E, Tritsaris K, Dissing S. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2005 Jul;13(7):575-81. doi: 10.1016/j.joca.2005.02.012.
PubMed 15979009Pipitone N, Scott DL. Magnetic pulse treatment for knee osteoarthritis: a randomised, double-blind, placebo-controlled study. Curr Med Res Opin. 2001;17(3):190-6. doi: 10.1185/0300799039117061.
PubMed 11900312Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.
PubMed 26705327
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01877278
- Acronym / sponsor ID
- 11262
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Pulsed electromagnetic fields, Device, Pain, Pressure algometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Posted 9 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.
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 |
|---|---|---|
| active | Active comparator | Device: Wearable pulsed electromagnetic fieldsGroup wearing the active device emitting pulsed electromagnetic fileds |
| placebo | Placebo comparator | Device: Wearable pulsed electromagnetic fieldsGroup wearing the device non-emitting pulsed electromagnetic fileds |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a diagnosis of primary OA of the knee according to the ACR criteria, including radiologic evidence of OA
- age >40 years
- symptomatic disease for at least 6 months prior to enrollment
- persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (NSAID), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (VAS) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
- ability to attend followup appointments
Key exclusion criteria (10 listed)
- secondary causes of OA
- local or systemic infection
- diabetes mellitus
- systemic arthritis
- allergy to anesthetic agent or contrast material
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 |
|---|---|---|
| Wearable pulsed electromagnetic fieldsAlso: actipatch | Device | active, placebo |
Primary outcome
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
Time frame: baseline and 4 weeks
visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)
Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4
Time frame: baseline and 4 weeks
Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8478852Trock DH, Bollet AJ, Dyer RH Jr, Fielding LP, Miner WK, Markoll R. A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. J Rheumatol. 1993 Mar;20(3):456-60.
- Background: PubMed 15979009Thamsborg G, Florescu A, Oturai P, Fallentin E, Tritsaris K, Dissing S. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2005 Jul;13(7):575-81. doi: 10.1016/j.joca.2005.02.012.
- Background: PubMed 11900312Pipitone N, Scott DL. Magnetic pulse treatment for knee osteoarthritis: a randomised, double-blind, placebo-controlled study. Curr Med Res Opin. 2001;17(3):190-6. doi: 10.1185/0300799039117061.
- Derived from this study: PubMed 26705327Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.
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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.
Gianfilippo Bagnato, Professor study chair
University of Messina
Gianfilippo Bagnato, MD principal investigator
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable pulsed electromagnetic fields in people with Knee Osteoarthritis, run by University of Messina at 1 site in Italy.
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 10 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 9 Feb 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 Italy. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 (time frame: baseline and 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 NCT01877278, which also lists 4 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 9 Feb 2015.