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

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ClinicalTrials.gov Identifier: NCT01877278
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Gianfilippo Bagnato, University of Messina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Wearable pulsed electromagnetic fields Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: active
Group wearing the active device emitting pulsed electromagnetic fileds
 Device: Wearable pulsed electromagnetic fields
Other Name: actipatch
Placebo Comparator: placebo
Group wearing the device non-emitting pulsed electromagnetic fileds
 Device: Wearable pulsed electromagnetic fields
Other Name: actipatch


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 [ Time Frame: 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)

  2. Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877278


Locations
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Italy
Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino
Messina, Italy, 98100
Sponsors and Collaborators
University of Messina
Investigators
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Study Chair: Gianfilippo Bagnato, Professor University of Messina
Principal Investigator: Gianfilippo Bagnato, MD University of Messina
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gianfilippo Bagnato, Professore ordinario, University of Messina
ClinicalTrials.gov Identifier: NCT01877278    
Other Study ID Numbers: 11262
First Posted: June 13, 2013    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: February 9, 2015
Last Verified: January 2015
Keywords provided by Gianfilippo Bagnato, University of Messina:
Osteoarthritis
Pulsed electromagnetic fields
Device
Pain
Pressure algometry
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases