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

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 |
- 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)
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Italy | |
Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino | |
Messina, Italy, 98100 |
Study Chair: | Gianfilippo Bagnato, Professor | University of Messina | |
Principal Investigator: | Gianfilippo Bagnato, MD | University of Messina |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Osteoarthritis Pulsed electromagnetic fields Device Pain Pressure algometry |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |