N/A N=44 Randomized Triple-blind Treatment

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

Neck Pain

Bottom Line

View on ClinicalTrials.gov: NCT05889039 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Neck Pain Rating Neck Disability Index (NDI) — 13; 7.4; 12.2; 11.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BEMER (Device); OMT (Procedure); Sham OMT + Sham BEMER (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Lake Erie College of Osteopathic Medicine
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Neck Pain Rating Neck Disability Index (NDI)	13; 7.4; 12.2; 11.2	—
PRIMARY Neck Pain Rating Visual Analog Scale (VAS)	15.5; 7.1; 16; 11.5	—
PRIMARY Quality of Life Rating Short Form 12-item (SF-12) Health Survey	47.5; 45.4; 43.7; 45.6	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT05889039). 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.