An interventional study of Wearable pulsed electromagnetic fields in Knee Osteoarthritis, sponsored by University of Messina. Completed at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-02-09.
Sponsored by University of Messina · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group wearing the active device emitting pulsed electromagnetic fileds
Device: Wearable pulsed electromagnetic fields
Group wearing the device non-emitting pulsed electromagnetic fileds
Device: Wearable pulsed electromagnetic fields
Also known as: actipatch
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)
Time frame: 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.
Time frame: baseline and 4 weeks
| Milestone | Active | Placebo |
|---|---|---|
| Started | 33 | 33 |
| Completed | 30 | 30 |
| Not completed | 3 | 3 |
| Withdrew: Lost to follow-up | 3 | 3 |
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)
| units on a scale | Active | Placebo |
|---|---|---|
| VAS (baseline) | 67 ± 16 | 63.6 ± 15 |
| VAS (after 1 month of treatment) | 50 ± 16 | 61 ± 15 |
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.
| units on a scale | Active | Placebo |
|---|---|---|
| WOMAC total (baseline) | 136 ± 49 | 129.2 ± 40.8 |
| WOMAC total (4 weeks) | 111 ± 48 | 126 ± 39 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | — | 0/30 (0%) | 0/30 (0%) |
| Placebo | — | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Active | Placebo | Total |
|---|---|---|---|
| Mean | 68.6 ± 11.9 | 66.9 ± 10 | 67.7 ± 10.9 |
| Sex: Female, Male(Participants) | Active | Placebo | Total |
|---|---|---|---|
| Female | 21 | 21 | 42 |
| Male | 9 | 9 | 18 |
| Region of Enrollment(participants) | Active | Placebo | Total |
|---|---|---|---|
| Italy | 30 | 30 | 60 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Messina