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Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on Neck Pain in Adults

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BEMER
OMT
Sham OMT + Sham BEMER
Sponsored by
Lake Erie College of Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Osteopathic Manipulative Treatment (OMT), BEMER

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lake Erie College of Osteopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

OMT + BEMER PLACEBO

Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy

OMT (Osteopathic Manipulative Treatment)

OMT+BEMER

Arm Description

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 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.

Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found.

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.

Outcomes

Primary Outcome Measures

Neck Pain Rating Neck Disability Index (NDI)
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
Neck Pain Rating Visual Analog Scale (VAS)
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
Quality of Life Rating Short Form 12-item (SF-12) Health Survey
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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
May 25, 2023
Sponsor
Lake Erie College of Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05889039
Brief Title
Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on Neck Pain in Adults
Official Title
Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on Neck Pain in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lake Erie College of Osteopathic Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Osteopathic Manipulative Treatment (OMT), BEMER

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMT + BEMER PLACEBO
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
OMT (Osteopathic Manipulative Treatment)
Arm Type
Active Comparator
Arm Description
Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found.
Arm Title
OMT+BEMER
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BEMER
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
OMT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham OMT + Sham BEMER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck Pain Rating Neck Disability Index (NDI)
Description
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
Time Frame
Prior to intervention and at the completion of three weeks
Title
Neck Pain Rating Visual Analog Scale (VAS)
Description
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
Time Frame
Prior to intervention and at the completion of three weeks
Title
Quality of Life Rating Short Form 12-item (SF-12) Health Survey
Description
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
Time Frame
Prior to intervention and at the completion of three weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Lorenzo, PhD, MS
Organizational Affiliation
Lake Erie College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lake Erie College of Osteopathic Medicine
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on Neck Pain in Adults

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