Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty

NCT02211534 | Completed Results

• 1 other identifier: RBI.2014.002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to investigate whether pulsed electromagnetic energy field (PEMF) therapy is effective in the treatment of persistent pain following total knee arthroplasty (TKA)

Conditions

Post-Operative Pain Following Total Knee Arthroplasty

Keywords

Pulsed Electromagnetic Energy Fields; Total Knee Arthroplasty; Pain Intensity

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents "Worst Pain Imaginable".

  Assessed at Day 60 as compared to Baseline

Secondary Outcomes (7)

• Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Mean change from Day 0 to Day 75

• Beck Depression Inventory (BDI)

  Responders at Day 75 (compared to baseline)

• Patient Global Impression of Change (PGIC)

  Day 75

• Analgesic Consumption

  Day 56 to Day 60 (compared to baseline)

• Change From Baseline in Range of Motion (ROM)

  Days 0 (Baseline) and Day 75

Study Arms (2)

Pulsed Electromagnetic Field Device

ACTIVE COMPARATOR

Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes.

Device: Pulsed Electromagnetic Field Device (Provant)

Sham Pulsed Electromagnetic Field Device

SHAM COMPARATOR

Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.

Device: Sham Pulsed Electromagnetic Field Device

Interventions

Pulsed Electromagnetic Field Device (Provant) DEVICE

The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment.

Also known as: Provant Therapy System

Pulsed Electromagnetic Field Device

Sham Pulsed Electromagnetic Field Device DEVICE

The Sham device will be identical in appearance, physical characteristics and operation to the Active device.

Also known as: Sham Provant Therapy System

Sham Pulsed Electromagnetic Field Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age is greater or equal to 18 years.
• Subject has undergone a total knee replacement for the treatment of osteoarthritis, and has persistent post-operative pain in the index knee for \> 3 months and \< 36 months following surgery.
• Subject has been receiving medication for persistent post-operative knee pain, including opioid or non-opioid analgesic medication that is administered on an "as needed" (prn) basis, and is on a stable analgesic dosing regimen (i.e. the same medications and dosages) for \> 30 days prior to the screening visit.
• Mean Pain Intensity (calculated as the mean of the daily average pain intensity scores) is ≥3 and \< 9 as measured on Numeric Pain Rating Scale (NPRS) during the run-in phase.
• Subject has completed a minimum of 80% (8 of 10 possible) of the pain intensity assessments during the run-in phase.
• Subject is willing and able to wear an activity meter from the screening visit through Day 75.
• Subject is able to access an internet browser in the home environment.
• Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
• Female Subjects must be post menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).

You may not qualify if:

• Subject has undergone simultaneous bilateral knee arthroplasty or revision arthroplasty on the index knee.
• Subject requires revision surgery prior to Day 75.
• Subject has undergone manipulation under anesthesia of the index knee or any local injection into the index knee within 30 days prior to the Screening Visit, or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
• Subject has received any investigational drug or device within 30 days prior to the Screening Visit or is enrolled in another clinical trial.
• Subjects consuming an average of \> 100 mg oral Morphine Sulfate equivalents per day during the run-in phase.
• Subject has evidence on physical or radiological exam of joint instability or infection involving the index knee.
• Passive range of motion demonstrates maximal flexion of the index knee \< 90 degrees or maximal extension of the index knee \< -10 degrees.
• Body Mass Index (BMI) \< 19 kg/m2, or \> 38 kg/m2.
• Subject has a history of any uncontrolled medical illness that in the investigator's judgment places the subject at unacceptable risk for receipt of Provant therapy.
• Subject has an ongoing painful condition that in the opinion of the Investigator might have a confounding influence on the safety or effectiveness analysis for this study.
• Use of systemic corticosteroids within 2 months of the Screening visit.
• Subject anticipates the need for surgery of any type through the Day 75 visit.
• Subjects whom, in the judgment of the Investigator, have serious psychosocial co-morbidities.
• History of drug or alcohol abuse within one year prior to screening.
• Subject has a history of malignancy within the past five years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized carcinoma in situ of the cervix.

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (14)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, 85018, United States

Location

Unknown Facility

Phoenix, Arizona, 85023, United States

Location

Unknown Facility

El Cajon, California, 92020, United States

Location

Unknown Facility

Lone Tree, Colorado, 80124, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Las Vegas, Nevada, 89128, United States

Location

Unknown Facility

New York, New York, 10022, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Unknown Facility

St. George, Utah, 84790, United States

Location

Unknown Facility

Danville, Virginia, United States

Location

Unknown Facility

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heather Vander Ploeg
• Organization: Regenesis Biomedical

Heather.VanderPloeg@regenesisbio.com

602-4287041

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 7, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 27, 2017
• Results First Posted: October 27, 2017

Record last verified: 2017-09

Locations

US (14)