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

NCT05889039 | Completed Results FDA Device

• 1 other identifier: 26-164
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Keywords

Neck Pain; Osteopathic Manipulative Treatment (OMT); BEMER

Outcome Measures

Primary Outcomes (3)

• 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

  Within 1 week of completion of 3-week intervention period

• 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

  Within 1 week of completion of 3-week intervention period

• 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

  Within 1 week of completion of 3-week intervention period

Study Arms (4)

OMT + BEMER PLACEBO

SHAM COMPARATOR

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.

Procedure: Sham OMT + Sham BEMER

Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy

ACTIVE COMPARATOR

Participants 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.

Device: BEMER

OMT (Osteopathic Manipulative Treatment)

ACTIVE COMPARATOR

Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found.

Procedure: OMT

OMT+BEMER

EXPERIMENTAL

Participants 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.

Device: BEMER; Procedure: OMT

Interventions

BEMER DEVICE

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.

Experimental: Bio Electro-Magnetic Regulation (BEMER) Therapy; OMT+BEMER

OMT PROCEDURE

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.

OMT (Osteopathic Manipulative Treatment); OMT+BEMER

Sham OMT + Sham BEMER PROCEDURE

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.

OMT + BEMER PLACEBO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lake Erie College of Osteopathic Medicine: lead

Study Sites (1)

Lake Erie College of Osteopathic Medicine

Bradenton, Florida, 34211, United States

Location

Related Publications (1)

• 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.

  PMID: 38033194 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Santiago Lorenzo
• Organization: LECOM

slorenzo@lecom.edu

941-782-5974

Study Officials

• Santiago Lorenzo, PhD, MS

  Lake Erie College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiology

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 5, 2023
• Study Start: September 17, 2019
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Locations

US (1)