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Completed

NCT Number: NCT06642688

Immediate Effect of Cervical and Sacroiliac Manipulation on the Autonomic Nervous System and Balance

The aim of this study is to investigate the immediate effects of high-velocity low-amplitude (HVLA) chiropractic manipulation on the autonomic nervous system and baropodometric parameters. The effects of different manipulation techniques on pedobarographic analysis and the autonomic nervous system were examined.

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Key information

Conditions

Neuromuscular Subluxation of Joint Autonomic Nervous System Activity Manual Therapy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinop University

Sinop, Turkey (Türkiye)

About this study

Ninety-six individuals who met the inclusion criteria participated in the study. The participants were divided into three groups: the sacroiliac joint manipulation group (n=32), the cervical manipulation group (n=32), and the control group (n=30). No treatment was administered to the control group, while sacroiliac joint manipulation and cervical manipulation were applied to the sacroiliac joint manipulation group and the cervical manipulation group, respectively. Autonomic nervous system activity was assessed using the Polar H-10 device, pedobarographic analysis was performed using the METISENS pedobarographic evaluation device, and blood pressure and pulse were measured manually from the left arm using a sphygmomanometer. A 30-minute waiting period was used during the evaluation of the control group. A significance level of p<0.05 was considered

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to participate voluntarily.
  • Signed informed consent form.
  • Age between 18 and 35 years.
  • No contraindications for chiropractic practices.

Exclusion criteria

  • History of orthopedic disabilities related to the lower extremity.
  • Ankylosing spondylitis, rheumatoid arthritis.
  • History of foot sprain/strain within the past six months.
  • Presence of pathologies in the lumbar and sacroiliac regions (herniated discs, spondylosis, spondylolisthesis).
  • History of cardiovascular and respiratory diseases.
  • Psychiatric disorders such as psychosis and depression.
  • Radicular root compressions causing progressive neurological deficits.
  • Bleeding/coagulation disorders and receiving anticoagulant treatment.
  • Acute fractures and orthopedic trauma.
  • Spinal cord tumors and meningeal tumors.
  • Intraosseous infections and acute inflammation, such as osteomyelitis.
  • Cauda equina syndrome.
  • Intracanicular hematomas.
  • Spinal cord hematomas in the spine.
  • Basilar invagination of the upper cervical region.
  • Aneurysmal bone cysts, osteoid osteomas, osteolastomas, giant cell bone tumors.
  • Post-surgical fixation prostheses.
  • Neoplastic diseases in muscles or other tissues.
  • Lhermitte's sign.
  • Syringomyelia.
  • Vertebral dislocations or hypermobile joints.
  • Advanced osteoporosis.
  • Vertebrobasilar insufficiency.

Criteria for Withdrawal from the Study:

  • Pregnancy or suspicion of pregnancy.
  • The volunteer's desire to discontinue participation in the study.

Treatment and study plan

Sacroiliac Joint Manipulation

Other

The patient was asked to tie his arms while he was in the side lying position. The patient's upper knee was flexed and positioned such that it was placed in the popliteal fossa of the lower knee, while the lower knee was in full extension. Pushing maneuver was performed with HVLA from posterior to anterior and from medial to lateral with pelvic rotation. The contact point of the sacroiliac joint was PSIS.

Cervical Spine Manipulation

Other

Cervical SM was applied supine to restrictions found on motion palpation, according to the technique described by Bergmann and Peterson28 The participant's head and neck were simultaneously rotated and laterally flexed over the contact point-specifically, the posterior supramastoid groove or zygomatic arch (C0-C1), the posterior aspect of the transverse process (C1-C2), or the posterior articular pillar of superior vertebrae (C2-C7) -to the end of passive ROM. Thereafter, a high-velocity, low-amplitude thrust was delivered in the direction of restricted movement. Participants with more ROM restriction in the lateral plane were given more lateral-to-medial directed thrusts; participants with more restriction in rotation were given thrusts in the direction of restricted axial rotation; and participants with more restriction in extension were given more anteriorly directed thrusts.

Primary outcomes

  1. Evaluation of Autonomic Nervous System

    Time frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.

    The assessment of the autonomic nervous system was conducted using the Polar H10 device, which is a high-accuracy, gold-standard HRV sensor that comes with a chest-worn strap. The device can connect to multiple components via Bluetooth and ANT+. This device facilitates the measurement of heart rate variability (HRV), R-R intervals, RMSSD (an instantaneous assessment of the parasympathetic system), LF Power (activation of the sympathetic nervous system), HF Power (activation of the parasympathetic nervous system), HF band, and LF/HF ratio (sympathetic-vagal balance).

    For data analysis, the Elite HRV software supported by the device is utilized. Measurements are conducted while the participant is seated and last approximately one minute. To ensure accurate measurements, it is necessary to moisten the electrode surface before each measurement. During the assessment, the participant should not speak or move

  2. Evaluation of Blood Pressure

    Time frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.

    Blood pressure of the participants were evaluated with a manual sphygmomanometer on the left arm.

  3. Analysis of Pedobarographic Data

    Time frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.

    The analysis of pedobarographic data was conducted using METISENS pedobarographic assessment devices. During the measurements of pressure analysis in individuals participating in our study, static conditions were maintained, and the load distribution on both the right and left feet, as well as the loads on the anterior and posterior aspects of the foot (%), were reported. Pressure analyses were determined using the Metisens Baropodometric Analysis software, which is the proprietary software that operates in conjunction with the Metisens Pedobarographic Assessment Device (It is not possible to separate these measurements as the device takes all measurements and provides a total analysis.)

  4. Evaluation of Pulse

    Time frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.

    The pulse of the participants were evaluated with a manual sphygmomanometer on the left arm.

Sponsors and collaborators

Lead sponsor

SEFA HAKTAN HATIK

Other

Registry information

Official study title

Comparison Of Spinal Manipulation Applied to the Cervical Spine and Sacroiliac Joints With Pedobarographic Analysis and It's Immediate Effect on the Autonomic Nervous System in Healthy Individuals

Acronym: CSMPAANS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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