Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee

A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee

The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Orthofix Physio-Stim Model 3315OA

Detailed Description

The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure. The primary objective of this study is to prospectively determine, at 12 months post treatment, the safety and efficacy of treating OA of the knee with PEMF. Safety will be assessed through adverse event collection. Study subjects will be randomized in a 2:1 ratio (active: placebo control) to either an active or placebo control (inactive) Physio-Stim device. The study is powered to detect a significant difference between groups when 120 subjects (80 active: 40 placebo control) have completed the study. Planned enrollment for the study is 150 subjects, to allow for an attrition rate of 20%.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject must be able to wear the investigational device so that there is adequate PEMF exposure to the knee.
2. Subject must have a body mass index ≤ 45 at the time of consent.
3. Subject must be at least forty (≥ 40) years of age of age at the time of consent.

4. Subject must have an established diagnosis of primary femorotibial OA in the target knee by modified American College of Rheumatology criteria for at least 6 months and at least one of the following:

   i. Stiffness less than 30 min ii. Crepitus (noise or cracking on knee motion)

5. Subject must have symptomatic Kellgren-Lawrence (K-L) Grades 1-3 OA by radiograph (PA flexion) within 90 days of screening, where the K-L grades are defined as:

   Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2: definite osteophytes and definite narrowing of joint space; Grade 3: moderate multiple osteophytes and definite narrowing of joint space and some sclerosis and possible deformity of bone contour

6. Subject must have a visual analog pain score between 4 cm and 8 cm on a 10 cm scale in the target knee at the time of screening.
7. Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm confirmed by radiograph.
8. Subject must be ambulatory.
9. Subject must NOT have had arthroscopy within 8 weeks of randomization.
10. Subject must NOT have had viscosupplementation within 8 weeks of randomization.
11. Subject must NOT have had NSAIDs within 1 week of randomization (low-dose aspirin as cardioprotective prophylaxis is permitted).
12. Subject must be willing to discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
13. Subject must be willing to take acetaminophen (up to 3000 mg/day) as pain medication for the duration of the study. Other pain medications may be allowed during the course of the study if the subject meets specific criteria.
14. Subject must be willing to STOP taking any pain medications 24 hours prior any scheduled study visit.
15. Subject must NOT have participated in a clinical study within the past 12 weeks that required the use of an investigational device, drug or biologic.
16. Subjects must be proficient in English.
17. Subject must be willing and able to sign an informed consent document.
18. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.

Exclusion criteria:

1. Subjects who have a body mass index > 45 at the time of consent.
2. Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.).
3. Subjects with a diagnosis of secondary arthritis (acromegaly, Charcot's arthropathy, hemochromatosis, Wilson's disease, ochronosis, etc.).
4. Subjects with confounding factors such as ipsilateral hip OA or chronic pain syndromes (fibromyalgia, Crohn's disease, ulcerative colitis, interstitial cystitis).
5. Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded.
6. Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening.
7. Subjects who have had intra-articular injections of hyaluronic acid within 8 weeks of screening.
8. Subjects who plan to have surgery on the target knee within the study period.
9. Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening.
10. Subjects with significant and clinically evident mal-alignment of the target knee (> 10 degrees varus or valgus in the target knee).
11. Subjects with surgical metallic hardware in the target knee.
12. Subjects with pain in any other area of the lower extremities or back that is equal to or greater than the pain in the target knee.
13. Subjects who have contraindications to MRI and X-rays, for example, implanted electrical devices (cardiac pacemakers, deep brain stimulators).
14. Subjects with a current malignancy or who have received treatment for malignancy with the last 5 years, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
15. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of chronic substance abuse (> 5 years).
16. Subjects with skin breakdown or infection in the area where the study device will be placed.
17. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) that have not been well-controlled for at least 3 months prior to screening.
18. Subjects who have any ongoing litigation for worker's compensation.
19. Subjects with any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
20. Subjects who are unwilling or unable to adhere to the follow up schedule and procedures.
21. Subjects who are pregnant.
22. Subjects who are prisoners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active PEMF; Subjects have a 2 out of 3 chance to get the active device which emits a Pulsed Electromagnetic Field (PEMF) from the Physio-Stim Model 3315OA device. Double blind randomization	Device: Orthofix Physio-Stim Model 3315OA; Active device emits PEMF signal; placebo/control device does not emit PEMF signal
Placebo Comparator: Control/no PEMF; Subjects have a 1 out of 3 chance of getting the control/placebo device which does not emit Pulsed Electromagnetic Field (PEMF) from the Physio-Stim Model 3315A device. Double blind randomization	Device: Orthofix Physio-Stim Model 3315OA; Active device emits PEMF signal; placebo/control device does not emit PEMF signal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change over time in WOMAC score	The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores and by a significantly increased number of study subjects achieving minimally clinical important differences (MCIDs).	6 mo, 12 mo

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: Principal Investigator: Roy K Aaron, MD, Warren Alpert Medical School of Medicine, Brown University, Providence, Rhode Island; Principal Investigator: Ronald Delanois, MD, Rubin Institute for Advance Orthopedics, Sinai Hospital of Baltimore

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; PEMF; pulsed electromagnetic fields
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CP-1403PSOA