Trial Outcomes & Findings for Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial (NCT NCT01877278)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

baseline and 4 weeks

Results posted on

2015-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Active emitting group Wearable pulsed electromagnetic fields	Placebo non emitting device Wearable pulsed electromagnetic fields
Overall Study STARTED	33	33
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Active emitting group Wearable pulsed electromagnetic fields	Placebo non emitting device Wearable pulsed electromagnetic fields
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=30 Participants emitting group Wearable pulsed electromagnetic fields	Placebo n=30 Participants non emitting device Wearable pulsed electromagnetic fields	Total n=60 Participants Total of all reporting groups
Age, Continuous	68.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	66.9 years STANDARD_DEVIATION 10 • n=7 Participants	67.7 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Italy	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Active n=30 Participants emitting group Wearable pulsed electromagnetic fields	Placebo n=30 Participants non emitting device Wearable pulsed electromagnetic fields
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	63.6 units on a scale Standard Deviation 15
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	61 units on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active n=30 Participants emitting group Wearable pulsed electromagnetic fields	Placebo n=30 Participants non emitting device Wearable pulsed electromagnetic fields
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	129.2 units on a scale Standard Deviation 40.8
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	126 units on a scale Standard Deviation 39

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gianfilippo Bagnato

University of Messina

Phone: 00390902212502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place