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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gianfilippo Bagnato, University of Messina
ClinicalTrials.gov Identifier:
NCT01877278
First received: June 11, 2013
Last updated: January 22, 2015
Last verified: January 2015
  Purpose

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 Intervention
Knee Osteoarthritis
Device: Wearable pulsed electromagnetic fields

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Messina:

Primary Outcome Measures:
  • Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 66
Study Start Date: June 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877278

Locations
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
Study Chair: Gianfilippo Bagnato, Professor University of Messina
Principal Investigator: Gianfilippo Bagnato, MD University of Messina
  More Information

Publications:
Responsible Party: Gianfilippo Bagnato, Professore ordinario, University of Messina
ClinicalTrials.gov Identifier: NCT01877278     History of Changes
Other Study ID Numbers: 11262
Study First Received: June 11, 2013
Results First Received: December 1, 2014
Last Updated: January 22, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by University of Messina:
Osteoarthritis
Pulsed electromagnetic fields
Device
Pain
Pressure algometry

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 29, 2015