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Neck PainNCT05889039

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

A study testing BEMER and OMT in people with Neck Pain, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neck Pain
What is being tested?
BEMER and OMT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited States
Study dates
17 Sep 2019to 16 Feb 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lake Erie College of Osteopathic Medicine

    Bradenton, Florida, 34211

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Neck Pain
Being tested
BEMER, OMT, Sham OMT + Sham BEMER
Keywords
Neck Pain, Osteopathic Manipulative Treatment (OMT), BEMER
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEMERDevice

    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.

  • OMTProcedure or surgery

    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.

  • Sham OMT + Sham BEMERProcedure or surgery

    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.

Study groups in NCT05889039
Study groupRoleWhat they receive
OMT + BEMER PLACEBOSham comparatorParticipants 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.
Receives: Procedure: Sham OMT + Sham BEMER
Experimental: Bio Electro-Magnetic Regulation (BEMER) TherapyActive comparatorParticipants 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.
Receives: Device: BEMER
OMT (Osteopathic Manipulative Treatment)Active comparatorParticipants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found.
Receives: Procedure: OMT
OMT+BEMERExperimentalParticipants 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.
Receives: Device: BEMER; Procedure: OMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 1 week of completion of 3-week intervention period

  2. 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

    Measured: Within 1 week of completion of 3-week intervention period

  3. 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

    Measured: Within 1 week of completion of 3-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start17 Sep 2019
  3. Primary completion16 Feb 2022
  4. Study completion16 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889039
Sponsor's protocol ID
26-164
Status last verified
Oct 2023
First submitted
10 May 2023
Last updated
15 Nov 2023
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Palmer GM, Dominick N, Kane M, Bawek S, Burch B, Sanders T, Phrathep D, Myers N, Lorenzo S. Effect of osteopathic manipulative treatment and Bio-Electro-Magnetic Energy Regulation (BEMER) therapy on generalized musculoskeletal neck pain in adults. J Osteopath Med. 2023 Dec 1;124(4):153-161. doi: 10.1515/jom-2023-0128. eCollection 2024 Apr 1.

    PubMed 38033194

Questions about this trial

What is this clinical trial studying?

A study testing BEMER and OMT in people with Neck Pain, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Pain Rating Neck Disability Index (NDI) (time frame: Within 1 week of completion of 3-week intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889039, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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