Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Low Back Pain in Adults.
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain
Study type: Interventional

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.

      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.
    

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.
    

Intervention name(s): Bio Electro-Magnetic Regulation (BEMER) Therapy; OMT (osteopathic manipulative treatment); Light touch
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): 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.; i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: OMM; BEMER