Understanding PEMF Through Clinical Studies

Note: These studies below were conducted using OrthoCor devices and demonstrate their efficacy in treating general pain, arthritis, and plantar fasciitis.

Prospective, Multi-Center, Randomized Study to Evaluate the OrthoCor Active System for Pain Relief

This study showed that treated with pulsed electromagnetic field (PEMF) therapy from the OrthoCor Active System experienced 26% more pain relief than those treated with standard of care (SOC) treatment.

“Participants in the active group received 2 hours of therapy each day from the OrthoCor Active System while participants in the control group (SOC) received alternative treatments such as NSAIDs, ice therapy, physical therapy, and other standard treatments. For 14 consecutive days the participants received treatment and rated their pain using the Mankoski pain scale.”

“When analyzing the efficacy of the OrthoCor Active System, a significant analgesic benefit was observed compared to Standard of Care (SOC). The OrthoCor Active System Group exhibited the least squares (LS) mean change in pain score from baseline of -1.8 (36% reduction, SE: 0.171), surpassing the SOC group’s reduction of -0.5 (10% reduction, SE: 0.181). The LS mean difference of -1.3 between the two groups (95% CI: -1.8 to -0.9), representing a 26% greater decrease in pain for the OrthoCor Active System Group, was statistically significant with a p-value <0.0001. The incidence of adverse events in this study was notably low, with only 4 out of 120 experiencing minor complications equally across both groups.”

“After the 14 days treatment, some patients from the SOC group elected to crossover to using the OrthoCor Active System. The 18 patients from the crossover group who submitted all pain scores experienced a further decrease in pain score, showing that adding the OrthoCor to the SOC treatment provided additional pain relief.”

“The OrthoCor Active System was significantly more effective than the Standard of Care (SOC) in reducing pain for soft tissue, with a 26% greater reduction in pain scores and a p-value of <0.0001. The number of adverse events was equivalent in the two groups and there were no significant complications, proving safety and tolerability. The crossover patients demonstrated that adding the OrthoCor Active System to the SOC treatment provided additional pain improvement. This randomized controlled clinical trial demonstrated that the OrthoCor Active System is an effective non-opioid solution in pain management that should be considered in the conservative treatment of pain and soft tissue injuries.”

Paci J, Hackel J, Gupta S.

Novel Approach to Plantar Fasciitis: Pulsed Electromagnetic Field Therapy

This study showed that patients with plantar fasciitis treated with pulsed electromagnetic field (PEMF) therapy from the OrthoCor Active System experienced healing of the plantar fascia as evaluated by ultrasound and an increase in function evaluated by survey scores. Plantar fascia thickness decreased by 34%, hypoechoic region width decreased by 79%, FADI survey score increased by 46%, and PSFS survey score increased by 166%.

“Ultrasound was used to measure plantar fascia maximal thickness and hypoechoic region width which indicates extent of injury. Function was evaluated using Foot and Ankle Disability Index (FADI) and Patient Specific Functional Scale (PSFS) survey scores.”

“Repeated measures ANOVA showed a statistically significant improvement in all assessments with use of PEMF therapy from the OrthoCor Active System. Mean thickness of the plantar fascia improved from 6.5 mm at the initial visit to 4.3 mm after 12 weeks of treatment, a decrease of 2.2 mm (34%) with a p-value of 0.005. Mean width of the hypoechoic region in the plantar fascia improved from 32 mm at the initial visit to 6.6 mm after 12 weeks of treatment, a decrease of 25.6 mm (79%) with a p-value of 0.004.”

“Mean FADI survey scores improved from 55 at the initial visit to 81 after 12 weeks of treatment, an increase of 25.4 (46%) with a p-value of <0.001. Mean PSFS survey scores improved from 2.9 at the initial visit to 7.7 after 12 weeks of treatment, an increase of 4.8 (166%) with a p-value of <0.001.”

“Pulsed Electromagnetic Field (PEMF) therapy from the OrthoCor Active System was effective for stimulating healing and improving function for patients with plantar fasciitis, demonstrated by significant improvement in ultrasound measurements and functional scores. This study suggests that PEMF therapy is an effective addition to the conservative treatment of plantar fasciitis.”

Bromley C

Note: The studies and publications below were performed independently of Caerus Corp and therefore have no bias or conflict of interests from our company. These studies illustrate the efficacy of PEMF technology but did not use OrthoCor Medical devices specifically. Refer to the full text of the studies for more details. 

The studies referenced here fall into two categories: randomized controlled trials and meta-analyses. A randomized controlled trial is an experiment where enrolled patients are randomly assigned different treatments and then some outcome is tested. A meta-analysis pools data from multiple randomized controlled trials to form stronger conclusions and find smaller differences.

This study pooled data from eleven trials (614 patients) and found that PEMF decreased pain, improved stiffness, and restored physical function for patients with osteoarthritis (OA).

“PEMF therapy ameliorates OA symptoms such as pain, stiffness, and physical function in patients compared to other conservative treatments.”

“Eleven RCTs consisting of 614 patients were enrolled in this meta-analysis, of which 10 trials comprised knee OA and one comprised hand OA. Compared with the control groups, the PEMF treatment yielded a more favorable output. PEMF alleviated pain (standardized mean differences [SMD] = 0.71, 95% confidence interval [CI]: 0.08–1.34, p = 0.03), improved stiffness (SMD = 1.34, 95% CI: 0.45–2.23,p=0.003), and restored physical function (SMD = 1.52, 95% CI: 0.49–2.55,p=0.004).”

Tong J, Chen Z, Sun G, et al. Pain Res Manag. 2022;2022:9939891. Published 2022 May 9.

Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery

This paper summarizes the accepted mechanism of action for PEMF as an increase in calcium ions (Ca2+) binding to calmodulin (CaM) leading to nitric oxide (NO) production which in turn regulates cGMP and releases growth factors that improve healing, such as fibroblast growth factor 2 (FGF-2).

“PEMF therapy has been used successfully in the management of postsurgical pain and edema, the treatment of chronic wounds, and in facilitating vasodilatation and angiogenesis.”

“This review shows that plastic surgeons have at hand a powerful tool with no known side effects for the adjunctive, noninvasive, nonpharmacologic management of postoperative pain and edema.”

“Considered together, all available evidence provides strong support for Ca/CaM-dependent transient NO production as an important PEMF transduction pathway for tissue repair. One of the authors (AAP) has recently proposed the PEMF mechanism as a working model for PEMF therapeutics (Figure 4). This mechanism suggests that the primary effect of clinically relevant PEMF signals is to increase the rate of Ca2+ binding to CaM, which then catalyzes cNOS (eg., eNOS), producing an immediate (within seconds) production of NO, which can orchestrate an antiinflammatory response via increased blood and lymph flow. NO, in turn, regulates cGMP production (within minutes), which cascades to the appropriate growth factor release dependent on the stage of healing (eg., FGF-2 for angiogenesis).”

Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA. Aesthet Surg J. 2009;29(2):135-143

This study pooled data from twelve trials (799 patients) and found that PEMF decreased pain for patients with knee and hand osteoarthritis (OA), but did not decrease pain for patients with cervical (neck) OA. It also found that PEMF sessions of 30 minutes or less were more effective than sessions longer than 30 minutes.

“PEMF could alleviate pain and improve physical function for patients with knee and hand OA, but not for patients with cervical OA. Meanwhile, a short PEMF treatment duration (within 30 min) may achieve more favourable efficacy.”

“Twelve trials were included, among which ten trials involved knee OA, two involved cervical OA and one involved hand OA. The PEMF group showed more significant pain alleviation than the sham group in knee OA (standardised mean differences (SMD)=-0.54, 95% CI -1.04 to -0.04, p=0.03) and hand OA (SMD=-2.85, 95% CI -3.65 to -2.04, p<0.00001), but not in cervical OA. Similarly, comparing with the sham-control treatment, significant function improvement was observed in the PEMF group in both knee and hand OA patients (SMD=-0.34, 95% CI -0.53 to -0.14, p=0.0006, and SMD=-1.49, 95% CI -2.12 to -0.86, p<0.00001, respectively), but not in patients with cervical OA. Sensitivity analyses suggested that the exposure duration <=30 min per session exhibited better effects compared with the exposure duration >30 min per session.”

Wu Z, Ding X, Lei G, et al. BMJ Open. 2018;8(12):e022879. Published 2018 Dec 14.

This study pooled data from fifteen trials (1078 patients) and found that PEMF improved pain, stiffness, function compared to placebo in patients with osteoarthritis. The improvement in quality of life was just below the level of statistical significance.

“Pulsed electromagnetic field (PEMF) therapy is a potentially useful treatment for osteoarthritis (OA), but its effectiveness is still controversial. This study aimed to examine the effects of PEMF therapy and PEMF parameters on symptoms and quality of life (QOL) in patients with OA.”

“Sixteen studies were included in our systematic review, while 15 studies with complete data were included in the meta-analysis. Our primary outcome was the standardized mean difference, which was equal to the treatment effect in the PEMF group minus the treatment effect in the placebo group divided by the pooled standard deviation. For pain, the standardized mean difference was 1.06 (95% CI = 0.61 to 1.51), for stiffness 0.37 (95% CI = 0.07 to 0.67), for function 0.46 (95% CI = 0.14 to 0.78), and for QOL 1.49 (95% CI = -0.06 to 3.04). PEMF parameters did not influence symptoms.”

“Compared with placebo, there was a beneficial effect of PEMF therapy on pain, stiffness, and physical function in patients with OA. Duration of treatment may not be a critical factor in pain management.”

Yang X, He H, Ye W, Perry TA, He C. Phys Ther. 2020;100(7):1118-1131.

This study pooled data from fourteen trials (618 patients) and found that PEMF decreased pain compared to placebo or other therapy in patients with chronic low back pain. There was also improvement in acute low back pain and physical function which fell just below the level of statistical significance (standardized mean difference (SMD) of -0.46 or -0.45, but a 95% confidence interval (CI) for the difference of -0.99 to 0.07 or -0.98 to 0.07, which both include 0).

“We included randomized controlled trials that investigated the effectiveness of PEMF in patients with low back pain. The primary outcome was pain intensity and the secondary outcome was physical function, both were evaluated by assessment scales.”

“Fourteen trials involving 618 participants were included. The PEMF treatment showed more significant pain alleviation than placebo or other therapy alone in patients with low back pain (SMD = -1.01, 95% CI -1.42 to -0.6, P < 0.001, I2 = 31%; SMD = -0.36, 95% CI -0.62 to -0.11, P = 0.005, I2 = 37%, respectively.) In addition, a significant difference in pain alleviation was observed in patients with chronic low back pain (SMD = -0.6, 95%CI – 0.94 to -0.25, p < 0.001, I2 = 67%), whereas no significant difference was observed in patients with acute low back pain (SMD = -0.46, 95%CI – 0.99 to 0.07, p = 0.09, I2 = 0%). PEMF did not improve physical function compared with the control treatment (SMD = -0.45, 95% CI – 0.98 to 0.07, p = 0.09, I2 = 86%).”

Sun X, Huang L, Wang L, et al. Clin Rehabil. 2022;36(5):636-649.

This study pooled data from nineteen trials (1303 patients) and examined PEMF combined with conventional medications and PEMF alone, each compared to conventional medications in postmenopausal women. When compared with conventional medications, PEMF combined with conventional medications increased bone mineral density (BMD), improved chemical markers, and decreased pain, but did not cause a statistically significant difference in adverse events, such as fractures. When compared to conventional medications, PEMF alone increased BMD in the femur and decreased pain but did not cause a statistically significant difference in BMD of the lumbar spine or in most of the chemical markers.

“Postmenopausal osteoporosis is a type of chronic disease with high morbidity and high economic burden. Due to the adverse effects of long-term drug therapy, physical therapy, such as pulsed electromagnetic fields (PEMF), is widely implemented in clinical practice.”

“Outcome indicators include bone mineral density (BMD), visual analogue scale (VAS), biochemical markers of alkaline phosphatase (ALP), osteocalcin, bone-specific alkaline phosphatase (BSAP), type I collagen carboxy-terminal peptide (CTX), and adverse events. The results showed that a total of 19 studies (1303 patients) were retrieved from eight databases. Compared with conventional medications, PEMF combined with conventional medications significantly increased BMD of lumbar vertebra, femoral, Ward’s triangle, bone-specific biochemical indicators of ALP, BSAP, and osteocalcin, and relieved pain. However, The incidence of adverse events was not statistically significant between PEMF combined with conventional medications and conventional medications alone. Compared with conventional medications, PEMF significantly increased the BMD of the femur and reduced the degree of pain, but there was no statistical difference in the BMD of the lumbar spine between PEMF and placebo. Except osteocalcin, BSAP, CTX, and ALP showed no significant difference. In view of its efficacy and safety, PEMF intervention can be considered as a potentially effective complementary therapy for postmenopausal women with osteoporosis.”

Lang S, Ma J, Gong S, Wang Y, Dong B, Ma X. Bioelectromagnetics. 2022;43(6):381-393.

Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients

In this study patients who used PEMF had 57% less pain at 1 hour, 300% less pain from 5 to 48 hours, and used half the narcotic pain medication in the first 48 hours after breast reduction surgery when compared to a sham device.

The researchers measured 275% less IL-1β, a chemical marker of inflammation that is affected by nitric oxide, in the fluid drained from the wounds of the patients using PEMF compared to a sham device.

“Pulsed electromagnetic fields produced a 57 percent decrease in mean pain scores at 1 hour (p < 0.01) and a 300 percent decrease at 5 hours (p < 0.001), persisting to 48 hours postoperatively in the active versus the control group, along with a concomitant 2.2-fold reduction in narcotic use in active patients (p = 0.002). Mean IL-1β concentration in the wound exudates of treated patients was 275 percent lower (p < 0.001).”

“Pulsed electromagnetic field therapy significantly reduced postoperative pain and narcotic use in the immediate postoperative period. The reduction of IL-1β in the wound exudate supports a mechanism that may involve manipulation of the dynamics of endogenous IL-1β in the wound bed by means of a pulsed electromagnetic field effect on nitric oxide signaling, which could impact the speed and quality of wound repair.”

Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Plast Reconstr Surg. 2010;125(6):1620-1629.

This study showed that electromagnetic field (EMF) signals caused an increase in chemical messengers like nitric oxide (NO) downstream of calmodulin (CaM), suggesting EMF increases the binding of calcium ions (Ca2+) to CaM.

“New EMF signals were configured to modulate calmodulin-dependent signaling and assessed for efficacy in cellular studies.”

“Configured EMF signals modulated CaM-dependent enzyme kinetics, produced several-fold increases in key second messengers to include nitric oxide and cyclic guanosine monophosphate in chondrocyte and endothelial cultures and cyclic adenosine monophosphate in neuronal cultures. Calmodulin antagonists and downstream blockers annihilated these effects, providing strong support for the proposed mechanism.”

“Results are consistent with the proposed mechanism, and strongly support the Ca/CaM/NO pathway as a primary EMF transduction pathway.”

Pilla A, Fitzsimmons R, Muehsam D, Wu J, Rohde C, Casper D. Biochim Biophys Acta. 2011;1810(12):1236-1245.

This study compared the use of a PEMF device to a sham device after arthroscopic knee surgery and showed improvement in function, decreased pain medication usage, and higher rate of return to normal activity.  Only about one fourth (26%) of the patients who used PEMF needed non-steroidal pain medication (NSAIDs) after 3 weeks, compared to three fourths (75%) of those who used a sham device.  Three years after surgery 10 out of the 16 respondents who had used PEMF returned to normal activity (6 had functional limitation), compared with only 1 out of the 8 respondents in the sham group (7 had functional limitation).

“The percentage of patients who used NSAIDs [beyond 3 weeks to control pain] was 26% in the active [PEMF] group and 75% in the control group (P = 0.015).”

“[Knee injury and Osteoarthritis Outcome Score] KOOS values at 45 and 90 days were higher in the active [PEMF] group and the difference was significant at 90 days (P < 0.05). The percentage of patients who used NSAIDs was 26% in the active group and 75% in the control group (P = 0.015). At 3 years follow-up, the number of patients who completely recovered was higher in the active group compared to the control group (P < 0.05).

“The KOOS values were higher in the active group than in the control group both at 45 days (73.6 ± 10.3 vs 70.3 ± 14.9, ns) and at 90 days (83.6 ± 7.3 vs 74.7 ± 13.6, P < 0.05).”

Zorzi C, Dall’Oca C, Cadossi R, Setti S. Knee Surg Sports Traumatol Arthrosc. 2007;15(7):830-834.

This study showed that PEMF caused nearly three times the decrease in pain and pain mediation use compared to a sham device when used by patients after breast augmentation surgery.

“VAS [Visual Analog Scale] data showed that pain had decreased in the active cohort by nearly a factor of three times that for the sham cohort by [Post-Operation Day] POD 3 (p < 0.001), and persisted at this level to POD 7. Patient use of postoperative pain medication correspondingly also decreased nearly three times faster in the active versus the sham cohorts by POD 3 (p < 0.001).”

“Pulsed electromagnetic field therapy, adjunctive to standard of care, can provide pain control with a noninvasive modality and reduce morbidity due to pain medication after breast augmentation surgery.”

Nelson FR, Zvirbulis R, Pilla AA. Rheumatol Int. 2013;33(8):2169-2173.

Effects of pulsed electromagnetic fields on postoperative pain: a double-blind randomized pilot study in breast augmentation patients

This study showed that PEMF caused nearly three times the decrease in pain and pain mediation use compared to a sham device when used by patients after breast augmentation surgery.

“VAS [Visual Analog Scale] data showed that pain had decreased in the active cohort by nearly a factor of three times that for the sham cohort by [Post-Operation Day] POD 3 (p < 0.001), and persisted at this level to POD 7. Patient use of postoperative pain medication correspondingly also decreased nearly three times faster in the active versus the sham cohorts by POD 3 (p < 0.001).”

“Pulsed electromagnetic field therapy, adjunctive to standard of care, can provide pain control with a noninvasive modality and reduce morbidity due to pain medication after breast augmentation surgery.”

Hedén P, Pilla AA. Aesthetic Plast Surg. 2008;32(4):660-666.

This study with patients suffering from lumbar radiculopathy showed patients who were treated with PEMF compared to placebo had statistically significant improvements in pain intensity, personal care, lifting, walking, sitting, standing, sleeping, and social life, and radiculopathy. Radiculopathy was evaluated by measuring the size (amplitude) and time delay (latency) of the nervous system response to stimulation, called somatosensory evoked potentials (SSEPs).

Visual Analog Scale (VAS) pain measurements decreased by 49% (7.1 to 3.6) for the PEMF group compared to 17% (7 to 5.8) for the placebo group, and (OSW) scores decreased by 56% (75 to 33) for the PEMF group compared to 35% (74 to 48) for the control group.

“PEMF therapy is an effective method for the conservative treatment of lumbar radiculopathy caused by lumbar disc prolapse. In addition to improvement of clinically observed radicular symptoms, PEMF also seems effective in reducing nerve root compression as evidenced by improvement of SSEP parameters after treatment.”

“Significant differences were observed between both groups before and after application of PEMF therapy relative to VAS (P=0.024), total OSW (P<0.001), and other domains of OSW score (pain intensity [P=0.009], personal care [P=0.01], lifting [P<0.001], walking [P<0.001], sitting [P<0.001], standing [P<0.001], sleeping [P<0.001], social life [P<0.001] and employment [P=0.003]). Other significant differences were observed between both groups relative to SSEP latency and amplitude of the evaluated dermatomes on the right side (P = 0.022 and P = 0.001, respectively), and left side latency and amplitude (P = 0.016 and P = 0.002, respectively).”

Omar AS, Awadalla MA, El-Latif MA. Int J Rheum Dis. 2012;15(5):e101-e108.

This study pooled data from six trials (210 patients) and found that PEMF decreased pain in patients with low back pain.

“Six studies were eligible inclusion on the qualitative analysis and five into the quantitative analysis, scoring an overall 6.8 points according the PEDro scale. The studies showed heterogeneity concerning the intervention protocols. Nevertheless, the effect sizes’ indicated a clear tendency to reduction of the pain intensity favoring the PEMF groups, reaching a minimal clinically important difference.”

“PEMF therapy seems to be able to relieve the pain intensity and improve functionality in individuals with low back pain conditions.”

Andrade R, Duarte H, Pereira R, et al. Porto Biomed J. 2016;1(5):156-163.

This study showed that PEMF therapy improved function, muscle strength, and pain compared to placebo in patients with shoulder impingement syndrome (SIS).

“Patients in the active PEMF group had a higher level of function and less pain at all follow-up time frames compared with baseline (P<.05). However, the placebo PEMF group had increased function and reduced pain only at the 9-week and 3-month follow-ups (P<.05)-that is, after performing the associated exercises. For the shoulder dynamometry, the active PEMF group had increased strength for lateral rotation at 9 weeks (P<.05), and increased strength for medial rotation at 9 weeks and 3 months (both P<.05) when compared with baseline. There was no significant difference for shoulder strength in the placebo PEMF group (P>.05), as well as no significant differences (P>.05) for all outcome measures.”

“The combination of PEMF and shoulder exercises is effective in improving function and muscle strength and decreasing pain in patients with SIS.”

Galace de Freitas D, Marcondes FB, Monteiro RL, Rosa SG, Maria de Moraes Barros Fucs P, Fukuda TY. Arch Phys Med Rehabil. 2014;95(2):345-352