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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Wearable pulsed electromagnetic fields
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Pulsed electromagnetic fields, Device, Pain, Pressure algometry

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active

placebo

Arm Description

Group wearing the active device emitting pulsed electromagnetic fileds

Group wearing the device non-emitting pulsed electromagnetic fileds

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2013
Last Updated
January 22, 2015
Sponsor
University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT01877278
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Pulsed electromagnetic fields, Device, Pain, Pressure algometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active
Arm Type
Active Comparator
Arm Description
Group wearing the active device emitting pulsed electromagnetic fileds
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Group wearing the device non-emitting pulsed electromagnetic fileds
Intervention Type
Device
Intervention Name(s)
Wearable pulsed electromagnetic fields
Other Intervention Name(s)
actipatch
Primary Outcome Measure Information:
Title
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4
Description
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
Title
Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianfilippo Bagnato, Professor
Organizational Affiliation
University of Messina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gianfilippo Bagnato, MD
Organizational Affiliation
University of Messina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino
City
Messina
ZIP/Postal Code
98100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
8478852
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.
Results Reference
background
PubMed Identifier
15979009
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.
Results Reference
background
PubMed Identifier
11900312
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.
Results Reference
background
PubMed Identifier
26705327
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.
Results Reference
derived

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

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