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

NCT ID: NCT06642688

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-07-01

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

Conditions

Neuromuscular Subluxation of Joint; Manual Therapy; Autonomic Nervous System Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Sacroiliac Joint Manipulation Group

Sacroiliac joint manipulation was performed on this group in the lateral decubitus position.

Group Type: EXPERIMENTAL

Sacroiliac Joint Manipulation

Intervention Type: 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 Joint Manipulation Group

Cervical joint manipulation was performed on this group in the supine position.

Group Type: EXPERIMENTAL

Cervical Spine Manipulation

Intervention Type: 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.

Control Group

This group did not undergo any interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sacroiliac Joint Manipulation

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.

Intervention Type: OTHER

Cervical Spine Manipulation

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SEFA HAKTAN HATIK

OTHER

Sponsor Role: lead

Responsible Party

SEFA HAKTAN HATIK

Asst. Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SEFA H HATIK, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Sinop University

Locations

Sinop University

Sinop, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CMT0006

Identifier Type: -

Identifier Source: org_study_id