Effect of osteopathic manipulative treatment and Bio-Electro-Magnetic Energy Regulation (BEMER) therapy on generalized musculoskeletal neck pain in adults

Study participants

A standardized recruitment email was sent in September of 2019 to all faculty, staff, and students at a medical college. No inclusion or exclusion criteria were applied at the time of the recruitment email. A total of 63 volunteers responded and were screened for eligibility based on inclusion and exclusion criteria at the time of receiving the informed consent.

The inclusion criteria required participants to be currently experiencing nonspecific neck pain for at least 2 weeks. Participants were excluded if they were unable to provide informed consent, were currently pregnant, or had a positive screening test (Spurling’s and Wallenberg tests). Participants were also excluded if they had a known medical history of: psychiatric conditions; skin disorders or open wounds; fasciitis or fascial tears; myositis; neoplasia; bone fracture; osteomyelitis; osteopenia; osteoporosis; coagulation abnormality; deep vein thrombosis; adrenal diseases or syndromes; numbness, tingling, or weakness in the upper extremities; acute respiratory infection; immunosuppressive syndromes or therapies; radiation or chemotherapy within the previous 3 years; lupus; congestive heart failure; body mass index greater than 30; medication changes or asthma exacerbations within the last 4 weeks; anticoagulant therapy; autoimmune diseases; known sensitivity to carotid sinus reflex; advanced carotid disease; or Down syndrome. Participants were excluded if they received any external manual intervention, physical therapy, chiropractic therapy, or massage therapy. Awareness of study group assignment also excluded participants from continuing in the study.

Among the 63 participants who responded, 44 met the inclusion criteria. Each of the 44 participants were randomly assigned to one of four study groups: OMT-only, BEMER-only, OMT+BEMER, or CONTROL (light touch and sham) utilizing the Microsoft Excel RAND and RANK functions. The participants in each study group were not made aware of the other treatment arms. Four subjects withdrew from the study. Forty subjects completed the study, and data for 38 of these subjects (excluding data for two participants in the CONTROL group) are included in our analyses.

Treatment groups

The duration of the intervention was 3 weeks. During that time, participants in the OMT group received OMT treatment three times per week, and those in the BEMER group received treatment five times per week. Participants in the OMT+BEMER group received three OMT treatments and five BEMER treatments weekly, and those in the CONTROL group received three light-touch OMT and five sham-BEMER treatments weekly. The frequency of both OMT and BEMER therapy was modeled after a previously published study that was performed to evaluate the individual and combined effects of BEMER therapy and OMT on low back pain [19]. There were 10 participants in each of the OMT group, BEMER group, and OMT+BEMER group, and eight participants in the CONTROL group. One subject was removed due to treatment by a chiropractor during the intervention phase. Another subject was removed due to awareness of inclusion in the CONTROL study arm.

Assessment and treatment protocols

A standardized osteopathic assessment and treatment protocol for neck pain was developed with a board-certified neuromusculoskeletal medicine (NMM)/OMM osteopathic physician (N.M.). The osteopathic structural examination and motion testing focused on the cervical and upper thoracic spine, temporomandibular joint, and first rib to diagnose dysfunctions commonly associated with neck pain. Second-year osteopathic medical students (N.D., G.P., M.D., S.B., B.B., T.S., and D.P.) were trained and assessed by a board-certified NMM/OMM osteopathic physician (N.M.) to ensure uniform technique on the standardized protocol that was developed for each group. Each participant received a standardized osteopathic structural examination and diagnosis of somatic dysfunctions during each treatment session. If a somatic dysfunction was not found, the associated treatment protocol for that area was not performed.

The students performed the following examination protocol for each session and recorded the findings on a standard form:

1. Observe and palpate cervical and thoracic muscles for tenderness, asymmetry, restriction of motion, and tissue texture (TART) changes

2. Perform atlanto–occipital (OA) joint, atlanto–axial (AA) joint, cervical vertebrae 2–7 (C2–C7), and thoracic vertebrae 1–4 (T1–4) intersegmental diagnosis

3. Assess the temporomandibular joint (TMJ) by opening and closing the jaw

4. Perform counterstrain tender-point screening for the following muscles: Medial pterygoid, Anterior C7, Anterior C8, and Posterior C1 inion

5. Assess for a first-rib somatic dysfunction

Treatment was provided after the osteopathic structural examination sequence was performed and recorded. Participants receiving OMT were treated with a standardized sequence to the areas where somatic dysfunctions were found:

1. Suboccipital release (constant inhibitory pressure), supine

2. Cervical contralateral traction, supine

3. Upper thoracic spine unilateral soft tissue pressure, prone

4. Thoracic inlet/outlet myofascial release (direct or indirect), supine

5. OA, AA, C2–7 somatic dysfunction muscle energy (postisometric relaxation), supine

6. T1–4 somatic dysfunction muscle energy technique (post-isometric relaxation), seated,

7. First-rib elevation dysfunction articulation, seated

8. Submandibular myofascial release (direct or indirect), supine

9. Counterstrain technique for the following muscles/locations: Medial pterygoid, Anterior C7, Anterior C8, and Posterior C1 inion

Participants receiving BEMER therapy laid supine on the BEMER mat (BEMER International AG, Carlsbad, CA). 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 min long) in week 1 through week 3. These settings were selected based on the manufacturer’s recommendations. OMT was performed before BEMER therapy for those in the combined group.

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 min. This was done to mimic myofascial release techniques; however, no pressure or action was done. In addition, the subjects laid supine on the BEMER mat (as they would do during a BEMER session), but the device was not activated.

Outcome assessment

At the first session (immediately prior to the intervention) and at the last session (immediately after the final intervention), the participants were required to fill out validated surveys. The three surveys utilized were the Neck Disability Index (NDI), Short Form 12-item Health Survey (SF-12), and Visual Analog Scale (VAS) [23], [24], [25]. The NDI, VAS, and SF-12 were completed electronically. The NDI is a questionnaire that provides information as to how neck pain has affected the subject’s ability to manage in everyday life. The SF-12 is a self-reported survey that measures the effects of health on daily activities; results of this survey are computed to yield both a ‘SF12-Physical’ and ‘SF12-Mental’ score based on responses to a single survey. The VAS is a 100 mm line that measures the participants’ subjective pain from “no pain” to “pain as bad as it could possibly be.”

The data were organized to represent average means scores at preintervention and postintervention for each of the four outcome measures:

1. Visual Analog Scale (VAS)

2. Neck Disability Index (NDI)

3. SF12 – Physical Component

4. SF12 – Mental Component

Blinded analysis of all data occurred after the conclusion of our 3-week intervention period. All responses were de-identified. Absolute changes in questionnaire scores from preintervention to postintervention were calculated for each participant. A one-way analysis of variance (ANOVA) was utilized to determine any statistical significance between the mean changes in the four groups. Normal distribution and equal variances were confirmed by Shapiro–Wilk test and Brown–Forsythe test, respectively. Significance was set at p<0.05, and values are presented as means±standard deviation (SD).

Limitations

Variability with multiple practitioners is always a potential challenge. Although there is some inevitable variability when several practitioners provide the treatment, all OMT was provided by second-year medical students who underwent over 10 h of training, along with baseline competency in OMT. Continuity between the participant and practitioner was not always feasible due to scheduling restraints.

The provision of treatment by second-year osteopathic medical students represents another limitation of this study. It is likely that there were certain components of the results, particularly the minimal beneficial effect of OMT seen reflected in the data, that were related to the relative inexperience of student providers. The medical students underwent extensive training by a board-certified NMM/OMM osteopathic physician, and were frequently re-evaluated as the study progressed; however, the results could certainly be strengthened if they are replicated by experienced osteopathic providers.

One important consideration in the analysis of the NDI and VAS data is that the population of subjects selected could have begun treatment at a lower baseline NDI and VAS than the general population. Although there was limited research on the average NDI and average reporting of pain on the VAS for comparison, the population of the majority of students in their 20s could have decreased the likelihood of producing a more substantial change from baseline. Due to their potentially lower experience of disability and pain, it would take more intervention for there to be a significant drop in neck pain and impaired functionality. Similarly, baseline health status may vary significantly between participants, and further analysis of individual survey responses may provide useful insight.

Additionally, the heightened awareness and caution of COVID-19 during the completion of the study created some challenges during the intervention period. Two participants, who were far along in their course of treatment/control, experienced a gap in treatments due to potential exposure to COVID-19. Although the course was completed in its entirety, it is possible that this gap as well as potential infection interfered with the results of the surveys provided.

Future studies

There remains a need for further investigation. Particularly, a larger sample size of participants is preferred. There is an additional need to evaluate the variety of neck pain ailments (acute, chronic, and acute-on-chronic) and accompanying symptoms, and how targeted protocols of treatment might be utilized to achieve more specific goals of treatment. Future studies, utilizing the study protocols defined in the present investigation, may shed further light on the applicability of OMT and BEMER therapy for a variety of musculoskeletal complaints. Data from this study might also be valuable for analysis in conjunction with data gathered from other studies utilizing this protocol, such as a previously coordinated study of a similar protocol for the study of OMT and BEMER on low back pain [19].