Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05889039 |
| Other study ID # |
26-164 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 17, 2019 |
| Est. completion date |
February 16, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
Lake Erie College of Osteopathic Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Neck pain is a common ailment in the United States. Although there are several different
treatments and approaches to help individuals with neck pain, the number affected by this
condition has been steadily increasing.
OMT has been shown to be helpful in the treatment of neck pain. In fact, the use of OMT has
been shown to increase mobility of the myofascial tissues, visceral motion and decrease pain
in patients with neck pain. Bio Electro-Magnetic Regulation (BEMER) Therapy is a therapeutic
modality that deploys a biorhythmically defined stimulus through a Pulsed Electromagnetic
Field (PEMF), which leads to an increase in blood flow. The positive effects of BEMER on the
circulation has been shown to result in significant increases in arteriovenous oxygen
difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of
red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the
treatment of neck pain by improving microcirculation in muscular tissue. Therefore, it is
possible that the combination of OMT and BEMER therapy may provide additive effects in
reducing neck pain. The purpose of this study is to investigate the individual and combined
effects of OMT and BEMER therapy on neck pain in adults.
Description:
Neck Pain is defined as "pain in the neck with or without pain referred to one or both upper
limbs that lasts for at least one day". It has been estimated that 66% of the population will
suffer from neck pain at some point during their lifetime and has been reported as the fourth
leading cause of disability worldwide. There is considerable variation in the reported
prevalence rates of neck pain, most likely because of differences in the definition of neck
pain and the lack of homogeneity in the studies. Current available studies suggest the
one-year estimated incidence of neck pain to range between 10.4% and 21.3%, with a higher
incidence noted in computer and office workers. The prevalence of neck pain ranges from 10%
to 20%, and the most common cause of neck pain in adults stems from degenerative changes in
the cervical spine. Most cases of neck pain tend to run an episodic course over one's
lifetime, thus relapses are relatively common.
The differential diagnosis for neck pain is extensive, and a methodical approach is essential
to rule out potentially life-threatening conditions. The vast majority of neck pain is not
due to organic pathology, and thus, has been termed "non-specific" or "mechanical".
Interventions available to manage neck pain include analgesics, physiotherapy, educational
modalities, exercise, and manual therapy. While useful in acute, short-term reduction of
pain, analgesic therapy such as NSAIDs (nonsteroidal anti-inflammatory drugs) produce
significant side effects of gastrointestinal bleeding and cardiovascular events. Use of
opioids, while also useful for acute, short-term pain relief, should produce hesitation in
prescription due to risk of opioid dependence and hyperalgesia syndromes.
Osteopathic manipulative treatment (OMT) is a fundamental skill set that osteopathic
physicians acquire early during their medical training and is widely utilized among
practicing osteopathic physicians to treat neck pain and other musculoskeletal complaints.
OMT is a unique, hands-on treatment modality used by osteopathic physicians to augment the
conventional management of neck pain and has been studied to demonstrate favorable outcomes
in the treatment of neck pain.
In addition to conventional treatment modalities, Bio-Electro-Magnetic Energy Regulation
(BEMER) therapy (BEMER International AG) has emerged as a proposed therapeutic option. BEMER
therapy utilizes a biorhythmically defined stimulus through a pulsed electromagnetic field.
BEMER devices operate with unique parameters and are postulated to have a primary effect of
improving tissue microcirculation. BEMER therapy leads to an increase in the number of open
capillaries, vasomotion of micro vessels, arteriovenous oxygen difference, arteriolar and
venular flow volume, and flow rate of red blood cells in a specific microcirculatory area.
Multiple studies have demonstrated positive results in musculoskeletal pain management with
the utilization of BEMER therapy. One study in particular demonstrated a potential additive,
subjective decrease in reported back pain and improved functional ability after treatment
with both OMT and BEMER therapy.
The musculoskeletal, lymphatic, and fascial concepts of OMT have long been comprehensively
and collectively proposed as the mechanisms by which the therapy provides alleviation of
common musculoskeletal ailments. Existing literature suggests benefit from OMT, however, the
need for further exploration of manual therapy remains. As previously discussed, BEMER
therapy can reduce musculoskeletal pain via enhanced microcirculation. Therefore, it is
plausible that the combination of OMT and BEMER therapy may potentially enhance circulation
to the vascular beds in myofascial tissue and could substantially reduce neck pain. The
objective of this study was to assess the individual and combined effects of OMT and BEMER
therapy in patients with non-specific neck pain.
