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Musculoskeletal PainNCT04704375

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

A study testing Bio Electro-Magnetic Regulation (BEMER) Therapy, OMT (osteopathic manipulative treatment) and Light touch in people with Musculoskeletal 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

It is clear that low back pain (LBP) is a major challenge in our society, which can lead to severe disability in many individuals. Although there are several different treatments and approaches to help individuals with LBP, the number affected by this condition has been steadily increasing. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Pain
What is being tested?
Bio Electro-Magnetic Regulation (BEMER) Therapy, OMT (osteopathic manipulative treatment) and Light touch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
13 Sep 2018to 9 Sep 2019
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • 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
  • Currently experiencing low back pain.

Who cannot join

  • Unable to provide informed consent
  • Currently pregnant
  • Medical history of current psychiatric conditions
  • Skin disorders or open wounds precluding skin contact
  • Fasciitis of fascial tears
  • Myositis
Show all 26Show fewer
  • Neurological symptoms such as numbness, tingling, weakness in lower extremities
  • Neoplasia
  • Cancer
  • 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, or known sensitivity to the carotid sinus reflex.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • LECOM-Bradenton

    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 Low Back Pain in Adults.

It is clear that low back pain (LBP) is a major challenge in our society, which can lead to severe disability in many individuals. Although there are several different treatments and approaches to help individuals with LBP, the number affected by this condition has been steadily increasing.

OMT has been shown to be helpful in the treatment of LBP. In fact, the use of OMT has been shown to increase mobility of the lumbar myofascial tissues, visceral motion and decrease pain in patients with LBP. 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 LBP by improving microcirculation in muscular tissue. In fact, BEMER with physiotherapy showed reductions in pain and fatigue acutely in patients with chronic low back pain. A systemic review of randomized controlled trials that investigated whether PEMF was effective in low back pain showed there was decrease in pain intensity and improved functionality in individuals with different low back pain conditions.

Therefore, it is plausible that the combination of OMT and BEMER therapy may help increase circulation to myofascial structures that influence low back restriction and pain. The purpose of this study is to investigate the individual and combined effects of OMT and BEMER therapy on low back pain.

Read the detailed description

Low back pain (LBP) has become a major challenge in our society and has a relatively high incidence and prevalence. Moreover, LBP currently affects people of all ages and is a leading contributor to disease burden worldwide [6]. Individuals affected by LBP may experience this discomfort and associated disability for several months, and a proportion may remain severely disabled. For nearly all people with low back pain, it is not possible to identify a specific nociceptive cause. Most people with new episodes of LBP may recover quickly; however, recurrence is common and in many cases, LBP becomes persistent and disabling.

Despite the overabundance of treatments and approaches devoted to LBP, this back related disability and the number of individuals affected have steadily been increasing. During the past three decades, changes have been made to key recommendations in national clinical practice guidelines. In fact, currently there is a bigger emphasis placed on self-management, physical and psychological therapies, and some forms of complementary medicine (such as spinal manipulation, massage, acupuncture), and less emphasis on pharmacological and surgical treatments.

Despite multiple clinical guidelines providing similar recommendations for managing low back pain, a substantial gap between evidence and practice exists. Osteopathic manipulative treatment (OMT) is a distinctive modality used by osteopathic physicians to complement conventional management of LBP. There is considerable variability in OMT approaches when treating for LBP. Furthermore, osteopathic physicians combine conventional and complementary treatments when caring for patients with LBP. This increased variability in the approach to care for LBP patients requires more empirical data to determine the best approaches to treat LBP. Franke et al. conducted a meta-analysis that investigated the effect of OMT in LBP. The authors reported that some studies observed significant effect of OMT on pain, whereas other reported either a non-significant effect, or an effect in favor of the control treatment. It is clear that more research to better describe the effects of OMT on LBP is warranted.

OMT is the application of hands-on forces to help improve physiologic function and/or support homeostasis that has been negatively altered by somatic dysfunction, which is an impairment of function of any area of the body system. These impairments can occur at the muscles, fascia, bones, joints, ligaments, vasculature, lymphatics and nerves. When somatic dysfunction is diagnosed, using an osteopaths' manual palpatory skills, it is treated with OMT. In general, OMT techniques can be classified as direct or indirect. Direct techniques such as muscle energy (ME), high velocity low amplitude (HVLA), soft tissue (ST), and myofascial release (MFR) engage the restrictive barrier and use a specifically applied force to correct the somatic dysfunction [21]. Indirect techniques such as MFR, counterstrain (CS), balanced ligamentous tension (BLT) disengage from the restrictive barrier and the affected body part is moved into its freedom of motion.

The etiology of low back pain is varied from visceral causes, to a lack of adequate blood flow to the muscles and musculoskeletal imbalance. Inadequate blood supply and/or inadequate oxygen consumption can influence muscle pain. The role of OMT is thought to primarily address the musculoskeletal component of back pain, which may help improve muscle blood flow. Two of the primary goals of treatment with osteopathic techniques are to restore mobility and decrease pain. Using trained palpatory skills to diagnose alterations in the fascial connections within the body, it is proposed that OMT techniques can help alleviate these alterations in the body that may lead to musculoskeletal disorders such as low back pain. Many studies that use OMT as the intervention to reduce low back pain, utilize a combination of direct and indirect techniques. The use of myofascial release technique has been shown to increase mobility of the lumbar myofascial tissues, visceral motion and decrease pain in patients with non-specific low back pain using ultrasound diagnostics.

One very promising alternative approach for the treatment of LBP is the use of Bio Electro-Magnetic Regulation (BEMER) Therapy. BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through a Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation 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 LBP by improving microcirculation in muscular tissue.

Though OMT has been shown to be effective clinically for patients in decreasing pain, little is known behind the specific mechanisms of action. It is believed all osteopathic techniques use the concepts of fascial connectivity throughout the body and therefore can help increase circulation and lymphatic flow. In one study, the use of OMT helped decrease autonomic and neuroendocrine markers in response to mental stress. In modeled studies, OMT modalities like MFR and CS showed possible effects in modifying cytokine secretion, improving wound healing, and modifying muscle contraction. These effects were shown to sometimes reverse repetitive muscle strain in the tissues. It is postulated that these strains may represent the phenomenon of somatic dysfunction. Another study showed improvement in lower extremity blood pressure, cell mass, intracellular water, basal metabolism, venous velocity, skin temperature, pain, and quality of life post MFR and physical therapy for post-menopausal women with venous insufficiency. As discussed previously, BEMER therapy has been shown to increase microcirculation. BEMER with physiotherapy showed reductions in pain and fatigue acutely in patients with chronic low back pain. A systemic review of randomized controlled trials that investigated whether PEMF was effective in low back pain showed there was decrease in pain intensity and improved functionality in individuals with different low back pain conditions [4]. Therefore the results from these studies suggest that the combination of OMT and BEMER therapy can potentially help increase circulation to myofascial structures that influence low back restriction and pain.

Being tested
Bio Electro-Magnetic Regulation (BEMER) Therapy, OMT (osteopathic manipulative treatment), Light touch
Keywords
OMM, BEMER
Medical subject headings
Musculoskeletal Pain

What participants receive

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

  • Bio Electro-Magnetic Regulation (BEMER) TherapyDevice

    BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation 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 LBP by improving microcirculation in muscular tissue.

  • OMT (osteopathic manipulative treatment)Procedure or surgery

    1. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
  • Light touchProcedure or surgery

    Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.

Study groups in NCT04704375
Study groupRoleWhat they receive
Bio Electro-Magnetic Regulation (BEMER) TherapyExperimentalSubjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.
Receives: Device: Bio Electro-Magnetic Regulation (BEMER) Therapy
OMT (Osteopathic Manipulative Treatment)Active comparatorEach subject in the OMT group received treatment 3 times per week for a period of 3 weeks.
Receives: Procedure: OMT (osteopathic manipulative treatment)
BEMER + OMTExperimentalEach subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.
Receives: Device: Bio Electro-Magnetic Regulation (BEMER) Therapy; Procedure: OMT (osteopathic manipulative treatment)
ControlSham comparatorFinally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.
Receives: Procedure: Light touch

What is being measured

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

  1. Low Back Pain Rating Visual Analog Scale

    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

  2. Low Back Pain Rating Oswestry Low Back Pain Questionnaire

    Assessed by questionnaire rating, compared with pre-intervention rating

    Oswestry low back pain questionnaire: Scores range 0-50. 0-4 indicating no disability; 5-14 indicating minimal disability; 15-24 moderate disability; 25-34 severe disability; 35-50 complete disability. 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 posted11 Jan 2021
  2. Study start13 Sep 2018
  3. Primary completion9 Sep 2019
  4. Study completion9 Sep 2019

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
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04704375
Sponsor's protocol ID
25-154
Status last verified
Apr 2023
First submitted
6 Jan 2021
Last updated
18 Nov 2023
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bio Electro-Magnetic Regulation (BEMER) Therapy, OMT (osteopathic manipulative treatment) and Light touch in people with Musculoskeletal 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 2 inclusion and 26 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 18 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 26 Apr 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?

Low Back Pain Rating Visual Analog Scale (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?
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 18 Nov 2023.

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