Clinical trial NCT06642688: Immediate Effect of Cervical and Sacroiliac Manipulation on the Autonomic Nervous System and Balance
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Subluxation of Joint
Manual Therapy
Autonomic Nervous System Activity
Keywords: Chiropractic
Cervical Spine
Sacroiliac Joint
Autonomic Nervous System
Pedobarographic Analysis
Lead sponsor: Sinop University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ninety-six participants who met the inclusion criteria were enrolled in the study and were divided into three groups: the sacroiliac joint manipulation group (n=32), the cervical manipulation group (n=32), and the control group (n=32). Sacroiliac joint manipulation was performed in the lateral decubitus position, while cervical manipulation was applied in the supine position, and no treatment was administered to the control group. All measurements were repeated before and immediately after the manipulations. The Mann-Whitney U test was used to determine whether the scores differed according to a dichotomous variable, while the Kruskal-Wallis test was used for variables with more than two categories. In cases where significant differences were found between categories, the Mann-Whitney U test with multiple comparisons was used to identify the source of the difference between the pairwise groups.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Autonomic Nervous System
timeFrame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
measure: Evaluation of Blood Pressure
timeFrame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
measure: Analysis of Pedobarographic Data
timeFrame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
measure: Evaluation of Pulse
timeFrame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Secondary outcomes:
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Sinop University
Study officials:
affiliation: Sinop University
name: SEFA H HATIK, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: