Physiological Responses to Osteopathic Manipulative Techniques in Healthy Young Adults
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      This study was designed to investigate the effect of selected osteopathic manipulative
      techniques (OMT) on cardiovascular functions in healthy young men and women.

      This work addressed questions regarding physiological responses to OMT in maintaining the
      cardiovascular homeostasis by (1) measuring changes in the cardiac autonomic nerves activity,
      (2) measuring changes in cardiovascular parameters such as blood pressure, cardiac
      contractility, and heart rate, and (3) investigating if changes in the cardiac autonomic
      nerves activity were related to changes in blood pressure, cardiac contractility, or heart
      rate.

      This controlled not-randomized pilot study with repeated measures was conducted at the Touro
      University Nevada College of Osteopathic Medicine. Healthy 21-35 years old students and
      employees volunteered in the study. The experimental group received the three cranial
      osteopathic manipulative techniques, occipital-atlantal decompression, occipital-mastoid
      decompression, and compression of the fourth ventricle, consecutively applied. This study
      included two control groups; one group received sham manipulations, and the second group did
      not receive any manipulations and was the non-touch group.

      The computerized MP150 BIOPAC System was used for data collection and analysis. The skin
      electrodes were used for the one-lead ECG and impedance cardiography. Digital data were
      recorded during the entire experimental protocol. The blood pressure was measured manually
      before and after the experimental procedure using blood pressure cuff and stethoscope.
      Cardiovascular responses to OMT were evaluated by using the heart rate variability test
      (HRV), calculating changes in cardiac contractility, and comparing changes in pre- and post-
      blood pressure readings.

      An analysis of variance (ANOVA) with a Bonferroni post-hoc test was used to evaluate
      treatment effects. The type I error rate (alpha) was set at 0.05.
    

Detailed description: 
      Healthy, 21-35 year old, male and female volunteers were recruited from Touro University
      students, faculty and staff using a brochure, poster, e-mail or personal conversation. Each
      participant signed an informed consent form. Participants were allowed to participate in
      multiple experiments (in the experimental and control groups) at least 7 days after the last
      experiment.

      Each subject's weight and height were measured before the procedure. Anthropometric measures
      were used in cardiac impedance analysis, and as descriptive statistics of the studied
      population. All cardiovascular parameters were recorded by using a non-invasive method. The
      disposable skin electrodes were used for impedance cardiography and a one-lead ECG.

      The subjects were lying in the supine position and were asked to relax. All surface
      electrodes were connected to the computerized MP150 BIOPAC System for data recording. The
      duration of experimental protocol was about 30 minutes, and included three intervals: 10
      minutes, pre-OMT rest phase (Rest); 8 to12 minutes (about 10 minutes) of the OMT/Sham
      (Manipulations); and 10 minutes post-OMT recovery phase (Recovery).

      OMT and sham manipulations were administered by an osteopathic physician. The participants
      were told to lie supine with physician seated at the side of the table facing the
      participant. Cranial OMT included three techniques and was administered in the following
      sequence: occipital-atlantal decompression, occipital-mastoid joint, and compression of the
      fourth ventricle. Control subjects received the sham manipulative procedure or relaxed in
      supine position (non-touch control). The total duration of OMT controlled by an osteopathic
      physician and was about 10 minutes.

      OMT and sham manipulations Occipital-atlantal decompression: Patient is in the supine
      position. The operator places the tip of a finger against the posterior tubercle of the atlas
      and holds that bone anteriorly, preventing it from moving posteriorly with the condyles as
      the patient nods or tips the head forward. This will release tension between the occipital
      condyles and the first cervical vertebrae.

      Occipital-mastoid joint decompression: The occipital squama is gently moved forward and
      upward (anteriorly and superiorly) with the pads of the long finger, and the mastoid process
      of the temporal bone is lifted anterolaterally with the pads of the index fingers. This
      technique decompresses the jugular foramen, which the vagus nerve passes through.

      Compression of the fourth ventricle: Manipulation is accomplished by having the operator's
      hands cupped to receive the lateral angles and supra-occiput on their thenar eminences.
      Gentle compression medially is maintained (generally 2 to 3 minutes) until tissue changes,
      such as a softening or increased motion, are noted in the supraoccipital area.

      Sham: The osteopathic physician placed his hands on the skull of the subject and did not
      influence cranial motion. The sham manipulative procedure (SMP) was administered for 10
      minutes.

      All manipulations were administered by the osteopathic physician; experiments were conducted
      at Touro University Nevada. Data were collected by a non-invasive method using BIOPAC
      Systems, Inc. Equipment MP150 for data acquisition and analysis. The protocol consisted of
      three phases: rest before manipulations (10 min), manipulations (OMT) (approximately 10 min),
      and recovery after manipulations (10 min).

      Data analysis Most cardiovascular response variables were measured at baseline, immediately
      after manipulation ("immediate response"), and at the end of protocol ("after rest"). The
      immediate responses and at the end of protocol were calculated on a percentage basis relative
      to baseline to control some individual variations.

      The percent response variables were each analyzed in a three-way analysis of variance (ANOVA)
      which included time ("Immediate response", "after rest"), treatment (cranial manipulation,
      sham), and sex (male, female) as fixed effects. For significant interactions in the ANOVA, a
      Bonferroni post-hoc test was used to compare treatment effects within time, sex, or both. The
      type I error rate (alpha) was set at 0.05. The relationships among dependent variables were
      described with Spearman correlations between percent response variables within. Analyses were
      done in Rv3.5.1 (R Core Team 2018).
    

Intervention name(s): Cranial manipulation group, or cranial osteopathic techniques (OMM); Sham manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Cranial OMT procedure:
Subjects were relaxed and lying on the back for entire time of the research protocol (approximately 30 min). Osteopathic physician performed the osteopathic manipulations using his hands. The physician gently applied a small amount of force to the neck and head to release tissue tension until feeling a softening and warmth of tissues. Subjects experienced a sensation of slight pulling, releasing, or relaxing of the tissue.; The osteopathic physician placed his hands on the skull of the subject but did not influence cranial motion.
Other intervention name(s): Cranial osteopathic manipulations, cranial osteopathic techniques, cranial OMT procedure; Sham
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Osteopathic manipulation; Autonomic; Cardiovascular