Trial Outcomes & Findings for Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty (NCT NCT02211534)

Last Updated: 2017-10-27

Results Overview

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".

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Assessed at Day 60 as compared to Baseline

Results posted on

2017-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Pulsed Electromagnetic Field Device Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Overall Study STARTED	24	11
Overall Study COMPLETED	11	6
Overall Study NOT COMPLETED	13	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulsed Electromagnetic Field Device n=24 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=11 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.	Total n=35 Participants Total of all reporting groups
Age, Continuous	62.42 Years n=5 Participants	63.82 Years n=7 Participants	62.86 Years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Pain Catastrophizing Score	19 units on a scale n=5 Participants	17.7 units on a scale n=7 Participants	18.59 units on a scale n=5 Participants
BMI	31.3 kg/m^2 n=5 Participants	31.7 kg/m^2 n=7 Participants	31.42 kg/m^2 n=5 Participants
PainDETECT Questionnaire	12.8 units on a scale n=5 Participants	12.7 units on a scale n=7 Participants	12.8 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Assessed at Day 60 as compared to Baseline

Population: Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 60 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 60 assessment. Subjects without a Day 60 assessment were left out of the analysis.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=22 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=10 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Change in Pain Intensity	-30.9 Units on a scale Standard Deviation 37.99	-29.7 Units on a scale Standard Deviation 30.58

SECONDARY outcome

Timeframe: Mean change from Day 0 to Day 75

Population: Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.

Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=22 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=10 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)	9.2 units on a scale Standard Deviation 19.02	8.9 units on a scale Standard Deviation 14.17

SECONDARY outcome

Timeframe: Responders at Day 75 (compared to baseline)

Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score. BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=22 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=10 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Beck Depression Inventory (BDI)	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 75

Responder Analysis at Day 75 (patents stating they are "Improved" to "Much Improved") using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=22 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=10 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Patient Global Impression of Change (PGIC)	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 56 to Day 60 (compared to baseline)

Population: Number of Participants Analyzed differs from numbers above due to the number of subjects reporting opioid analgesic consumption in their ePRO diary.

Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=10 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=4 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Analgesic Consumption	-20.6 Number of tablets taken Standard Deviation 18.04	-22.2 Number of tablets taken Standard Deviation 16.78

SECONDARY outcome

Timeframe: Days 0 (Baseline) and Day 75

The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=21 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=9 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Change From Baseline in Range of Motion (ROM) Passive Extension ROM - Baseline	3.2 degrees of motion Standard Deviation 2.81	3.6 degrees of motion Standard Deviation 4.13
Change From Baseline in Range of Motion (ROM) Change from Baseline - Active Felexion ROM -Day 75	3.7 degrees of motion Standard Deviation 9.19	5.2 degrees of motion Standard Deviation 7.69
Change From Baseline in Range of Motion (ROM) Change from Baseline - Passive Extension ROM-Day75	-.5 degrees of motion Standard Deviation 3.72	.4 degrees of motion Standard Deviation 3.09
Change From Baseline in Range of Motion (ROM) Active Extension ROM - Baseline	4.4 degrees of motion Standard Deviation 3.37	4.2 degrees of motion Standard Deviation 3.8
Change From Baseline in Range of Motion (ROM) Change from Baseline - Active Extension ROM-Day75	-.8 degrees of motion Standard Deviation 3.49	.6 degrees of motion Standard Deviation 2.4
Change From Baseline in Range of Motion (ROM) Change from Basline - Passivie Flexion ROM-Day 75	3.0 degrees of motion Standard Deviation 9.19	4.6 degrees of motion Standard Deviation 4.93
Change From Baseline in Range of Motion (ROM) Passive Flexion ROM - Baseline	110.3 degrees of motion Standard Deviation 11.44	110.0 degrees of motion Standard Deviation 16.05
Change From Baseline in Range of Motion (ROM) Active Flexion ROM - Baseline	107.7 degrees of motion Standard Deviation 10.35	106.8 degrees of motion Standard Deviation 14.85

SECONDARY outcome

Timeframe: Day 75

The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure.

Outcome measures

Outcome measures
Measure	Pulsed Electromagnetic Field Device n=21 Participants Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=9 Participants Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm)	.1 cm Standard Deviation 1.46	-.1 cm Standard Deviation 0.75

SECONDARY outcome

Timeframe: At Days 75, 90, 150 and 240, as compared to Baseline

Population: Data were not collected.

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).

Outcome measures

Outcome data not reported

Adverse Events

Pulsed Electromagnetic Field Device

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham Pulsed Electromagnetic Field Device

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pulsed Electromagnetic Field Device n=24 participants at risk Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): 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.	Sham Pulsed Electromagnetic Field Device n=11 participants at risk Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 6/24 • Number of events 6	9.1% 1/11 • Number of events 1
General disorders Chest Pain	0.00% 0/24	9.1% 1/11 • Number of events 1
Cardiac disorders Arrhythemia	0.00% 0/24	9.1% 1/11 • Number of events 1
Infections and infestations Urinary tract infection	0.00% 0/24	9.1% 1/11 • Number of events 1
Injury, poisoning and procedural complications Burns second degree	0.00% 0/24	9.1% 1/11 • Number of events 1
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/24	9.1% 1/11 • Number of events 1
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/24	9.1% 1/11 • Number of events 1
Skin and subcutaneous tissue disorders Rash	0.00% 0/24	9.1% 1/11 • Number of events 1

Additional Information

Heather Vander Ploeg

Regenesis Biomedical

Phone: 602-4287041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication Rights. Independent analysis and/or publication of data generated is not permitted without the prior written consent of the sponsor. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
Publication restrictions are in place

Restriction type: OTHER