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

NCT01877278 | Completed Results

• 1 other identifier: 11262
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Pulsed electromagnetic fields; Device; Pain; Pressure algometry

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  baseline and 4 weeks

Study Arms (2)

active

ACTIVE COMPARATOR

Group wearing the active device emitting pulsed electromagnetic fileds

Device: Wearable pulsed electromagnetic fields

placebo

PLACEBO COMPARATOR

Group wearing the device non-emitting pulsed electromagnetic fileds

Device: Wearable pulsed electromagnetic fields

Interventions

Wearable pulsed electromagnetic fields DEVICE

Also known as: actipatch

active; placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino

Messina, Messina, 98100, Italy

Location

Related Publications (4)

• 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.

  PMID: 8478852 BACKGROUND

• 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.

  PMID: 15979009 BACKGROUND

• 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.

  PMID: 11900312 BACKGROUND

• 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.

  PMID: 26705327 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gianfilippo Bagnato
• Organization: University of Messina

gianbagnato@gmail.com

00390902212502

Study Officials

• Gianfilippo Bagnato, Professor

  University of Messina

  STUDY CHAIR

• Gianfilippo Bagnato, MD

  University of Messina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore ordinario

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 9, 2015
• Results First Posted: February 9, 2015

Record last verified: 2015-01

Locations

IT (1)