Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889039
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-05-10
Brief Title:
Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Neck Pain in Adults
Sponsor:
Lake Erie College of Osteopathic Medicine
Organization:
Lake Erie College of Osteopathic Medicine
Study Overview
Official Title:
Effects of Osteopathic Manipulative Treatment OMT and Bio Electro-Magnetic Regulation BEMER Therapy on Neck Pain in Adults
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 104 and 213 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 ones 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None