Clinical trial NCT01877278: Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial
Official title: Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Pulsed electromagnetic fields
Device
Pain
Pressure algometry
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
timeFrame: baseline and 4 weeks
measure: Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4
timeFrame: baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino
Study officials:
affiliation: University of Messina
name: Gianfilippo Bagnato, Professor
role: STUDY_CHAIR
affiliation: University of Messina
name: Gianfilippo Bagnato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Thamsborg 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.
citation: Pipitone 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.
citation: Bagnato 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.