- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889039
Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Neck Pain in Adults
Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on Neck Pain in Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Bradenton, Florida, United States, 34211
- Lake Erie College of Osteopathic Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- LECOM-Bradenton faculty, staff and Students currently enrolled in LECOM- Bradenton's osteopathic medical program, pharmacy program, dental program, and master's program who are currently experiencing neck pain for at least two weeks will be approached for recruitment.
Exclusion Criteria:
Subjects will be excluded if they have previously participated in the study, are unable to provide informed consent, are currently pregnant, or have a known medical history of any of the following:
- Psychiatric conditions
- Skin disorders or open wounds precluding skin contact
- Fasciitis or fascial tears
- Myositis
- Neurological symptoms such as numbness, tingling, weakness in upper extremities
- Neoplasia
- Bone fracture, osteomyelitis, or osteoporosis
- Coagulation problem
- Deep vein thrombosis
- Adrenal diseases/syndromes
- Acute upper or lower respiratory infection
- Immunosuppressive syndromes
- Radiation or chemotherapy within the past 3 years
- Lupus
- Osteopenia
- Congestive heart failure
- BMI greater than 30
- Any other autoimmune disease not stated above
- Medication changes within the last 4 weeks
- Asthma exacerbations within the last 4 weeks
- Immunosuppressive therapy as a consequence of organ transplantation
- Immunosuppressive therapy as a consequence of allogeneic cellular transplantations or bone marrow stem cell transplantation
- Other conditions often requiring immunosuppressive therapy
- Anticoagulant therapy
- Known sensitivity to the carotid sinus reflex
- Advanced carotid disease
- Down syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: OMT + BEMER PLACEBO
Participants in the CONTROL group received light touch and BEMER sham treatments.
Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes.
This was done to mimic myofascial release techniques; however, no pressure or action was done.
In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.
|
Participants in the CONTROL group received light touch and BEMER sham treatments.
Researchers placed their hands lightly on the subject's cervical paraspinal muscles in the supine position and on the upper thoracic paraspinal muscles in the prone position for approximately 5 minutes.
This was done to mimic myofascial release techniques; however, no pressure or action was done.
In addition, the subject's laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.
|
Active Comparator: Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy
Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG).
The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3.
The B.Pad (BEMER International AG) was placed under their cervical region.
B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3.
These settings were selected based on the manufacturer's recommendations.
|
Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.
|
Active Comparator: OMT (Osteopathic Manipulative Treatment)
Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found.
|
Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
|
Experimental: OMT+BEMER
Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG).
The BEMER was set at intensity 3 for week 1, intensity 4 for week 2, and intensity 5 for week 3.
The B.Pad (BEMER International AG) was placed under their cervical region.
B.Pad® settings were set at Program 1 (8 minutes long) in week 1 through week 3.
These settings were selected based on the manufacturer's recommendations.
OMT was performed prior to BEMER therapy for those in the combined group.
Participants were treated with a standardized sequence to the areas where somatic dysfunctions were found.
|
Bio-Electro-Magnetic Energy Regulation (BEMER) is an emerging therapeutic modality that deploys a biorhythmically defined stimulus through a pulsed electromagnetic field and has been shown to reduce musculoskeletal pain.
Osteopathic manipulative therapy (OMT) is a form of manual therapy utilized by osteopathic physicians and some allopathic physicians to treat a broad variety of musculoskeletal ailments, including neck pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Pain Rating Neck Disability Index (NDI)
Time Frame: Within 1 week of completion of 3-week intervention period
|
Assessed by questionnaire rating, compared with pre-intervention rating Neck Disability Index (NDI).
Score ranges 0-50.
Minimum score=0 (no activity limitation), Maximum score=50 (complete activity limitation).
Lower scores is better as it reflect lower activity limitation
|
Within 1 week of completion of 3-week intervention period
|
Neck Pain Rating Visual Analog Scale (VAS)
Time Frame: Within 1 week of completion of 3-week intervention period
|
Assessed by questionnaire rating, compared with pre-intervention rating Visual Analog Scale (VAS).
Score ranges 0-100.
Minimum score=0 (no pain), Maximum score=100 (worst pain ever felt).
Lower scores is better as it reflect lower pain
|
Within 1 week of completion of 3-week intervention period
|
Quality of Life Rating Short Form 12-item (SF-12) Health Survey
Time Frame: Within 1 week of completion of 3-week intervention period
|
Assessed by questionnaire rating, compared with pre-intervention rating Short form 12-item (SF-12) health survey.
Scores range 0%-100%.
Score of 0 (minimum) no pain.
Score of 100 (maximum) lot of pain.
Lower scores is better as it reflect lower pain
|
Within 1 week of completion of 3-week intervention period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Santiago Lorenzo, PhD, MS, Lake Erie College of Osteopathic Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-164
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Sham OMT + Sham BEMER
-
University of Milano BicoccaItalian School of Osteopathy and Manual Therapies; Alpha Search MilanoWithdrawnTension-Type Headache
-
University of North Texas Health Science CenterNational Institutes of Health (NIH); National Center for Complementary and... and other collaboratorsCompletedLow Back PainUnited States
-
University of North Texas Health Science CenterOsteopathic Heritage Foundations; American Osteopathic AssociationTerminatedType 2 Diabetes Mellitus | Chronic Low Back PainUnited States
-
New York Institute of TechnologyAmerican Osteopathic AssociationRecruitingType2 Diabetes Mellitus | Osteopathy in Diseases Classified ElsewhereUnited States
-
Methodist Medical Center of IllinoisUniversity of Illinois College of Medicine at Peoria; OSF Healthcare SystemUnknown
-
University of OklahomaOklahoma State University Center for Health SciencesCompleted
-
Wake Forest University Health SciencesNot yet recruitingInterstitial Cystitis | Bladder Pain Syndrome | Chronic Interstitial CystitisUnited States
-
Wake Forest University Health SciencesNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingInterstitial Cystitis | Bladder Pain Syndrome | Chronic Interstitial CystitisUnited States
-
University of MinnesotaCompletedManipulation, OsteopathicUnited States
-
Michigan State UniversityCompletedChronic Obstructive Pulmonary DiseaseUnited States