Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Pulsed electromagnetic fields, Device, Pain, Pressure algometry
Brief 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 the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.
Interventions
DEVICEWearable pulsed electromagnetic fields
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* secondary causes of OA * local or systemic infection * diabetes mellitus * systemic arthritis * allergy to anesthetic agent or contrast material * coagulopathy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | 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 | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active emitting group
Wearable pulsed electromagnetic fields | 30 |
| Placebo non emitting device
Wearable pulsed electromagnetic fields | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Active | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 11.9 | 66.9 years STANDARD_DEVIATION 10 | 67.7 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Italy | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | VAS (baseline) | 67 units on a scale | Standard Deviation 16 |
| Active | Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | VAS (after 1 month of treatment) | 50 units on a scale | Standard Deviation 16 |
| Placebo | Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | VAS (baseline) | 63.6 units on a scale | Standard Deviation 15 |
| Placebo | Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | VAS (after 1 month of treatment) | 61 units on a scale | Standard Deviation 15 |
p-value: <0.0001t-test, 2 sided
p-value: >0.05t-test, 2 sided
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | WOMAC total (baseline) | 136 units on a scale | Standard Deviation 49 |
| Active | Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | WOMAC total (4 weeks) | 111 units on a scale | Standard Deviation 48 |
| Placebo | Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | WOMAC total (baseline) | 129.2 units on a scale | Standard Deviation 40.8 |
| Placebo | Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | WOMAC total (4 weeks) | 126 units on a scale | Standard Deviation 39 |
p-value: =0.0001t-test, 2 sided
p-value: >0.05t-test, 2 sided