Electromagnetic Transduction Therapy in Patients with Chronic Aseptic Osteitis Pubis
Tim Klüter1*,
Martin Ringeisen2, André Krath1,
Munjed Al Muderis3, Rainer Mittermayr4,
Ludger Gerdesmeyer1
1Department of Orthopedic
Surgery and Traumatology, University Schleswig Holstein, Campus Kiel, Germany
2Orthopaedic Medical
Center, Augsburg, Germany
3The Australian School of
Advanced Medicine, Macquarie University, North Ryde, New South Wales, Australia
4Ludwig Boltzmann
Institute for Experimental and Clinical Traumatology, Wien, Austria
*Corresponding author: Tim Klüter, Department Orthopedic Surgery and Traumatology, University
Schleswig Holstein, Campus Kiel, Arnold Heller Strasse 3, 24105 Kiel, Germany. Tel: +4943150024401; Email: Tim.Klueter@uksh.de
Received
Date: 30 August, 2018; Accepted Date:
24 September, 2018; Published Date: 28 September, 2018
Citation: Klüter T, Ringeisen M, Krath A, Al Muderis M, Mittermayr R, et al. (2018) Electromagnetic Transduction Therapy in Patients with Chronic Aseptic Osteitis Pubis. J Orthop Ther: JORT-1113. DOI: 10.29011/2575-8241.001113
1. Abstract
1.1. Objective: Chronic aseptic osteitis pubis is a common cause for groin pain in athletes and is associated with unit or bilateral inguinal pain. MRI images document bony stress of the pubis, however the pathophysiological mechanism has not been clarified. Therapy is difficult and often frustrating because of insufficient specific treatment options. More recently, Electromagnetic Transduction Therapy (EMTT) has been utilized in musculoskeletal disorders but to date, its effects in osteitis pubis have not been determined.
1.2. Design/Methods: After at least 2 months of unsuccessful conservative therapy nine sport active patients with chronic aseptic osteitis pubis were treated with 4 sessions of EMTT (15 minutes at 80mT with an impulse frequency of 2.5 Hz). Visual Analogue Scale (VAS) was tested pre and post intervention as well as 3 months follow- up. Anthropometric data, stages of osteitis pubis and duration of rehabilitation were documented.
1.3. Results: Pain (VAS) decreased significantly after EMTT. Patients were able to return to sport and work after treatment without any medication.
1.4. Conclusion: EMTT is a novel and effective way in reducing pain in patients with chronic aseptic osteitis pubis.
2. Keywords: EMTT; Groin Pain; Osteitis Pubis; PEMF
3.
Introduction
Groin pain is a common overuse ailment and due
to a multiplicity of causes it can be challenging for orthopedic surgeons. A
differential diagnosis to consider is aseptic osteitis pubis, which is more
prevalent in sports related diseases [1].
Patients with osteitis pubis usually present with uni or bilateral inguinal
pain referring into the adductors, abdominal muscles or directly over the
symphysis. Athletes with osteitis pubis often suffer from debilitating
symptoms, a slow recovery and have a high recurrence rate [2]. MRI images of the pelvis document bony stress
reactions of the symphysis pubis, the surrounding soft tissues, tendons and
muscles. However, the pathophysiological mechanism has not been fully
identified. It is assumed that osteitis pubis constitutes a biomechanical
overloading of the pubic symphysis adjacent parasymphyseal bone and soft
tissue. This may explain why common track and field sports like soccer, hockey
and rugby as well as overloading (i.e.lifting heavy loads) may provoke osteitis
pubis. Other predisposing factors may include injuries, pregnancies,
rheumatological pathologies, gynaecological or urological interventions. Osteitis
pubis is staged based on level of severity as described by Rodrigues, et al. [3]. Conservative treatments including oral
analgesics, physiotherapy, injections and reduction of weight bearing are first
line management strategies. Other treatments that have been discussed include
bisphosphonates, platelet rich plasma and shock wave therapy [4-6]. Patients often require long periods of
rehabilitation with recovery times varying between 2 and 12 months [7]. In 5 -10 % of cases conservative treatments fail
and surgical intervention may be indicated [8].
However, surgery is costly, may result in peri- or postoperative complications
and longer periods of rehabilitation. Given this, new treatment alternatives
are warranted.
A promising technology for non-invasive
treatment of musculoskeletal disorders is Pulsed Electromagnetic Fields (PEMF).
PEMF are selected low-frequency electromagnetic fields without ionising or
thermal effect [9]. The growing interest in their
mechanisms of action leads to numerous in-vitro trials confirming their effectiveness
as an agonist of adenosine receptor A2A and A3 under exposure of PEMF, reducing
PGE2 and pro-inflammatory cytokine IL-6 and IL-8 and inhibiting factor NF-kB
transcription in human chondrocytes, synoviocytes and osteoblasts [10-12]. Several studies have documented the
effectiveness of PEMF in stimulating activity and differentiation of specific
cell cultures of the musculoskeletal system. PEMF devices have FDA approval to
fuse broken bones, reduce tissue and joint pain and support muscle function [13]. Due to inadequate electromagnetic field power
and missing dynamic oscillation,
PEMF was enhanced and a new technology based on
PEMF called Electromagnetic Transduction Therapy (EMTT) was developed. With
EMTT, magnetic field strength between 80 and 150mT and oscillating frequencies
of 120Hz of each impulse can be reached. Impulses were emitted by a high-speed
generator to build up a voltage of up to 30 kV, which is released in
nanoseconds and an impulse release frequency of 3 Hz. The very short duration
of each impulse ensures full electrophysical reaction without any temperature
increase in the tissue. Currently, the effects of EMTT on osteitis pubis have
not been determined in clinical trials. The aim of this study was to analyse
the efficiency of EMTT in patients with chronic aseptic osteitis pubis.
4.
Methods
4.1.
Design
The study was performed as a prospective
non-randomised trial between April 2015 and June 2017.
4.2.
Patients or Participants
Nine patients aged between 22 and 68 years with
overuse related aseptic osteitis pubis who participate in moderate sport
activity (3 hours per week) such as tennis, volleyball, cycling and running
were included in this study. Criteria for diagnosis of osteitis pubis included
unilateral or bilateral groin pain, tender to palpation, positive squeeze test
and evidence of bone marrow oedema on MRI scans. All patients in the trial were
staged as level 3 to 4 according to Rodriguez, et al. [3].
Patients were required to have undergone at least 2 months of unsuccessful conservative
treatment, such as physiotherapy or pharmacological treatments. In the case of
pharmacological treatments, oral and/or topical analgesics and non-steroidal anti-inflammatory
drugs were tried
Exclusion criteria included infection, tumor of
the pelvis or pathological neurological findings. All patients provided written
informed consent. The trial was conducted in accordance with the standardized
guidelines of good clinical practice from the International Conference on
Harmonization.
4.3.
Procedures
Patients underwent
identical EMTT electromagnetic transduction therapy twice a week for two weeks
(a total of four sessions). To perform EMTT the Cellactor MT1 device (Storz
Medical AG, Tägerwilen, Switzerland) was utilized. Each treatment was performed
over 15 minutes at 80mT with an impulse frequency of 2.5 Hz and an electric
power of 30 kV as suggested by the German Society for electromagnetic transduction
therapy (DIGEMTT). During treatment intervals patients were allowed to take up
to 1600mg of Ibuprofen and 2000mg of Metamizol per day if needed. No other
therapies were allowed. The primary outcome parameter for assessing the effect
of EMTT was groin pain reduction measured by a VAS scale. Subjective rest pain
sensation quantified by scoring on the 10-point VAS was documented pre and post
intervention as well as at 3 months follow-up. In addition, a patient’s return
to work duration and sports related activity was documented.
4.4.
Statistical Analysis
The sample size was based on the model of
stochastic superiority within the parametric student t-test or non-parametric
Mann-Whitney test. A value of p < 0.05 was considered statistically
significant.
5.
Results
All participants were treated according to the
study protocol whereof all patients reached the 3-month-follow-up. The required
number of pulses was achieved in all treatments. A mean age of the included
patients was 53 years (±13.5) (Table 1).
A history of 2 to 24 months (mean 12.6) of
unsuccessful conservative treatment was reported. A baseline VAS of 7.5 ± 1.0 was recorded on the day of first EMTT treatment (Figure 1).
During the period of EMTT patients were allowed
to take preexisting analgesic medication if necessary. At first follow up,
directly after last EMTT, the pain score decreased to VAS of 0.5 (± 0.72) and after 3 months a VAS of 0 for all patients
was measured. MRI images before EMTT document an edema of the os pubis, which
disappeared in the follow-up examination one week after last EMTT session (Figure 2).
All patients returned to work after the last
EMTT session. Two patients returned to sport activities after one day, one
patient returned after a week, another patient returned after 2 weeks and the
final patient returned after 3 weeks.
No clinically significant adverse effects such
as erythema, hematoma, neurologic disorders, tendon rupture, infection, or
necrosis were observed in any of the patients during the course of the study.
6.
Discussion
Due to long-lasting pain and high recurrence
rates, aseptic osteitis pubis is known as a debilitating disease in active
people. Currently there are no standardized diagnostic or therapeutic
guidelines established [14]. Therapy is
difficult and often frustrating because of low specific treatment options.
Athletes with groin pain often need to refrain from sport for more than 6
months, which is hardly acceptable in professional athletes. With respect to
health economics, patients with aseptic osteitis pubis are unable to work for
several weeks. Therefore, it is crucial to establish new effective and
non-surgical treatment modalities with minimal side effects. The current trial
provides evidence for the efficiency of EMTT in patients with chronic aseptic
osteitis pubis for the first time. All patients had constant severe pain for several
months and showed significant pain reduction after two weeks of EMTT. In the
first 2 weeks after EMTT doses of analgesia could be reduced in all cases and after
the last EMTT session, no patient required any analgesia. After a 3 month follow-up
all patients were asymptomatic. Even the edema of the bone disappeared after
last EMTT intervention. During the last decade the interest in PEMF treatment
of musculoskeletal disorders has increased significantly. The benefits of PEMF
have been shown for lateral epicondylitis pain [15],
rotator cuff tendinopathy [16], particularly in
fracture healing based on stimulating cell proliferation and induce
osteoblastogenesis and the differentiation of osteoblasts [17]. Overuse of the osteitis pubis caused by the attached
ventromedial muscular-tendinous string with the abdominal and adductor muscles
may result in repetitive microtrauma. PEMF may stimulate bone healing in osteitis
pubis.
Several studies have
demonstrated the anti-inflammatory effect of PEMF exposure in human
synoviocytes, chondrocytes, and osteoblasts with a significant reduction in the
most relevant pro-inflammatory cytokines (interleukin-6 and interleukin-8),
tumor necrosis factor-alpha [12,18,19]. In
addition, neovasculogenesis, release of growth factors and improvement of blood
supply are affected by electromagnetic impulses. These effects of
proangiogenisis and increased tissue regeneration of PEMF might be the main
reason for pain and disability reduction in our study population. One of the
most important physical parameters of PEMF is defined as electromagnetic power
measured in Millitesla (mT). PEMF acts via electromagnetic transduction
resulting in engineering a larger treatment area up to 30cm in diameter. Most
clinical trials initially failed to prove efficacy, due to less power, inducing
significant biological reaction and activate repair mechanism. In the current
study we used EMTT with 80mT, to initiate significant clinical effects, which
is a promising electromagnetic power [20]. To
our knowledge, there are no serious side effects of EMTT and the study did not identify
any adverse effects. Considering the aforementioned, EMTT therapy is safe and
easily applicable. Although a small cohort of patients was included in this
trial, we could demonstrate significant reduction in pain levels, even amongst
patients with chronic pain. Another limiting aspect of the trial was the short
follow-up time. However, this was a
pragmatic trial: it is unlikely that, in
clinical practice, patients would accept to be monitored for two years following
treatment if they were no longer symptomatic. Our study was created as a
feasibility trial to analyze EMTT as a possible option for cases, which are
resistant to common therapies. Further placebo-controlled and randomized
studies will strengthen the evidence for the effectiveness of EMTT in treatment of chronic aseptic osteitis pubis. They have to be
designed the way that sports specific effects and the effect of different level
of activities will be analyzed to give specific recommendations to treat
chronic osteitis more efficient. To conclude it can be said, that EMTT is an
effective way in reduce pain in patients with chronic aseptic osteitis pubis.
Figure 1: VAS decreased
significantly after 2 weeks of EMTT treatment P<0.05.
Figure 2: (A) Before the first
EMTT session MRI of the pelvis documents intraosseous oedema of the pubis in
patient with aseptic osteitis pubis. (B) After last EMTT session the oedema has
disappeared.
patient |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
stage |
3 |
3 |
3 |
4 |
3 |
3 |
4 |
3 |
3 |
dominance |
right |
left |
left |
left |
right |
right |
both sides |
left |
right |
trigger |
weight lifting |
tennis |
soccer |
weight lifting |
car accident |
standing profession |
gardening |
soccer |
badminton |
sport |
cycling |
tennis/volley ball |
soccer |
cycling |
Nordic walking |
cycling |
nordic walking |
soccer |
badminton |
time until EMTT |
6 months |
3 months |
4 months |
2 months |
2 years |
1 week |
3 weeks |
8 months |
9 months |
return to work (after last session) |
1 day |
1 day |
1 day |
1 day |
1 day |
1 day |
1 day |
1 day |
1day |
return to sports (after last session) |
1 day |
2 weeks |
1 week |
1 day |
3 weeks |
1 day |
1 day |
1 day |
2 weeks |
Table 1: Anthropometric data, stages of osteitis pubis, duration of rehabilitation.