Neuromuscular Subluxation of JointCSMPAANSNCT06642688
Immediate Effect of Cervical and Sacroiliac Manipulation on the Autonomic Nervous System and Balance
A study testing Sacroiliac Joint Manipulation and Cervical Spine Manipulation in people with Neuromuscular Subluxation of Joint and Manual Therapy, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Subluxation of Joint, Manual Therapy, Autonomic Nervous System Activity
- What is being tested?
- Sacroiliac Joint Manipulation and Cervical Spine Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to participate voluntarily.
- Signed informed consent form.
- Age between 18 and 35 years.
- No contraindications for chiropractic practices.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Sacroiliac Joint Manipulation, Cervical Spine Manipulation
- Keywords
- Chiropractic, Cervical Spine, Sacroiliac Joint, Autonomic Nervous System, Pedobarographic Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac Joint ManipulationOther
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 ManipulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sacroiliac Joint Manipulation Group | Experimental | Sacroiliac joint manipulation was performed on this group in the lateral decubitus position. Receives: Other: Sacroiliac Joint Manipulation |
| Cervical Joint Manipulation Group | Experimental | Cervical joint manipulation was performed on this group in the supine position. Receives: Other: Cervical Spine Manipulation |
| Control Group | No intervention | This group did not undergo any interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Autonomic Nervous System
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
Measured: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Evaluation of Blood Pressure
Blood pressure of the participants were evaluated with a manual sphygmomanometer on the left arm.
Measured: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Analysis of Pedobarographic Data
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.)
Measured: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Evaluation of Pulse
The pulse of the participants were evaluated with a manual sphygmomanometer on the left arm.
Measured: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 May 2024
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Subluxation of JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
- Investigators
- SEFA H HATIK, Asst. Prof., Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642688
- Sponsor's protocol ID
- CMT0006
- Acronym
- CSMPAANS
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06642688
- Acronym / sponsor ID
- CSMPAANS / CMT0006
- Keywords
- Chiropractic, Cervical Spine, Sacroiliac Joint, Autonomic Nervous System, Pedobarographic Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sacroiliac Joint Manipulation Group | Experimental | Other: Sacroiliac Joint ManipulationSacroiliac joint manipulation was performed on this group in the lateral decubitus position. |
| Cervical Joint Manipulation Group | Experimental | Other: Cervical Spine ManipulationCervical joint manipulation was performed on this group in the supine position. |
| Control Group | No intervention | –This group did not undergo any interventions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willingness to participate voluntarily.
- Signed informed consent form.
- Age between 18 and 35 years.
- No contraindications for chiropractic practices.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacroiliac Joint ManipulationThe 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. | Other | Sacroiliac Joint Manipulation Group |
| Cervical Spine ManipulationCervical 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. | Other | Cervical Joint Manipulation Group |
Primary outcome
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
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.
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.)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Subluxation of Joint
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Active, not recruiting
Physiotherapist Supervised Training in Patients With Anterior Shoulder Instability
Shoulder Instability Subluxation Bilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEFA H HATIK, Asst. Prof. principal investigator
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacroiliac Joint Manipulation and Cervical Spine Manipulation in people with Neuromuscular Subluxation of Joint and Manual Therapy, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.