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

NCT04704375 | Completed Results FDA Device

• 1 other identifier: 25-154
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Pain

Keywords

OMM; BEMER

Outcome Measures

Primary Outcomes (3)

• 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

  Within 1 week of completion of 3-week intervention period

• 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

  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)

Bio Electro-Magnetic Regulation (BEMER) Therapy

EXPERIMENTAL

Subjects in the BEMER group received treatment 5 times per week for a period of 3 weeks.

Device: Bio Electro-Magnetic Regulation (BEMER) Therapy

OMT (Osteopathic Manipulative Treatment)

ACTIVE COMPARATOR

Each subject in the OMT group received treatment 3 times per week for a period of 3 weeks.

Procedure: OMT (osteopathic manipulative treatment)

BEMER + OMT

EXPERIMENTAL

Each subject in the BEMER + OMT group received treatment 3 times per week for a period of 3 weeks.

Device: Bio Electro-Magnetic Regulation (BEMER) Therapy; Procedure: OMT (osteopathic manipulative treatment)

Control

SHAM COMPARATOR

Finally, subjects in the Placebo group will receive the light touch and BEMER sham treatments at same intervals as the corresponding experimental groups.

Procedure: Light touch

Interventions

Bio Electro-Magnetic Regulation (BEMER) Therapy DEVICE

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.

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

OMT (osteopathic manipulative treatment) PROCEDURE

i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.

BEMER + OMT; OMT (Osteopathic Manipulative Treatment)

Light touch PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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
• Currently experiencing low back pain.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lake Erie College of Osteopathic Medicine: lead

Study Sites (1)

LECOM-Bradenton

Bradenton, Florida, 34211, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Therapeutics; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Dr. Santiago Lorenzo
• Organization: LECOM

slorenzo@lecom.edu

941-782-5974

Study Officials

• Santiago Lorenzo, PhD

  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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiology

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 11, 2021
• Study Start: September 13, 2018
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: November 18, 2023
• Results First Posted: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)