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N/A N=40 Randomized Single-blind Treatment

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

Musculoskeletal Pain

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Low Back Pain Rating Visual Analog Scale — 44.5; 32.1; 38.2; 34.1 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Bio Electro-Magnetic Regulation (BEMER) Therapy (Device); OMT (osteopathic manipulative treatment) (Procedure); Light touch (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Lake Erie College of Osteopathic Medicine
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Low Back Pain Rating Visual Analog Scale
44.5; 32.1; 38.2; 34.1
PRIMARY
Low Back Pain Rating Oswestry Low Back Pain Questionnaire
14.8; 14.4; 11.2; 10.8
PRIMARY
Quality of Life Rating Short Form 12-item (SF-12) Health Survey
46.8; 44.9; 46.0; 48.6

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.

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
  • Currently experiencing low back pain.

Exclusion Criteria

  • 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
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04704375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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