Peripheral Nerve DiseaseNCT06569563
Innervation Characteristics and Determination of Nerve Entry Points of the Musculus Semispinalis Capitis
An observational study of Peripheral Nerve Disease and Muscular Injury, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the innervation characteristics and nerve entry points of the musculus semispinalis capitis. This muscle, which is involved in the extension of the head and neck, is a large and long cervico-thoracic muscle innervated by the dorsal rami of the cervical spinal nerves. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Peripheral Nerve Disease, Muscular Injury
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 14 Jun 2019
- Phase
- Observational
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted using 10 adult male cadavers, aged between 45 and 75 years, that had been fixed in 10% formalin solution. These cadavers were sourced from the laboratory of the Department of Anatomy at Ege University Faculty of Medicine.
Who may be able to join
- Cadavers were preserved using a 10% formalin solution.
Who cannot join
- neck and back region curvature,
- neck flexion and extension,
- related region muscle or nerve pathology,
- fracture,
- cadavers that have undergone previous surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Kavacık, 34815
About this study
The aim of this study is to determine the innervation characteristics and nerve entry points of the musculus semispinalis capitis. This muscle, which is involved in the extension of the head and neck, is a large and long cervico-thoracic muscle innervated by the dorsal rami of the cervical spinal nerves. The study seeks to enhance the effectiveness of procedures like electromyography (EMG) electrode placement and botulinum toxin injections used for diagnosing and treating conditions related to head and neck pain.
Accurately identifying these nerve entry points is crucial for ensuring the safety and efficacy of treatments, particularly for conditions like cervical dystonia and headaches. While existing studies have focused on the innervation and nerve mapping of various muscles, there has been no specific research on the nerve entry points of the musculus semispinalis capitis. This study aims to provide detailed knowledge of these aspects, offering valuable guidance for interventions in this area.
Read the detailed description
The musculus semispinalis capitis, one of the cervical paraspinal muscles, originates from the transverse processes of the last cervical and the first six to seven thoracic vertebrae. It extends upward along both sides of the posterior midline and inserts between the superior and inferior nuchal lines on the occipital bone. This muscle is innervated by the dorsal rami of the cervical spinal nerves. As a large and long cervico-thoracic muscle, its primary function is the extension of the head and neck.
The aim of this study is to determine the innervation characteristics and nerve entry points of the musculus semispinalis capitis to enhance the effectiveness of procedures such as the placement of electromyography (EMG) electrodes for diagnostic and therapeutic purposes, as well as botulinum toxin injections used for treating conditions associated with head and neck pain.
The innervation characteristics and nerve entry points of the musculus semispinalis capitis need to be precisely identified, particularly in relation to treatments such as botulinum toxin injections for the management of spasms and pain in conditions like cervical dystonia, and for the treatment of headaches. Accurate identification of these points is crucial for ensuring safe and effective injections in this region and for understanding the anatomical variations in the area.
While there are studies in the literature focusing on the innervation characteristics and nerve entry points of various muscles, as well as nerve mapping, there has been no specific research on nerve entry point mapping for the musculus semispinalis capitis. Conducting this study will establish a detailed understanding of the innervation characteristics and nerve entry points of this muscle, providing valuable guidance for interventions in this area.
Previous studies on deep neck muscles have shown that procedures such as injections and EMG measurements have generally been performed using approximate localization methods. This study aims to use the results obtained to make these procedures more effective and less invasive.
- Conditions
- Peripheral Nerve Disease, Muscular Injury
- Keywords
- m. semispinalis capitis, paraspinal muscle, muscle innervation mapping, cervical spine surgery, musculoskeletal anatomy, nerve entry point, intramuscular injection, cervical dystonia, botulinum toxin injections, innervation
- Medical subject headings
- Peripheral Nervous System Diseases, Torticollis
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of nerves innervating the semispinalis capitis muscle
The semispinalis capitis muscle is innervated by many nerves, primarily the dorsal branches of the cervical spinal nerves. The number of branches of the dorsal branches of the cervical nerves that enter the muscle was determined and counted one by one.
Measured: 10 months
The location of nerves innervating the semispinalis capitis muscle
In order to determine which cervical nerve branch of the semispinalis capitis muscle was concentrated in which areas of the muscle, the perpendicular distances of the points where the nerves entered the muscle to the determined landmarks were measured and recorded in mm.
Measured: 10 months
The thickness of nerves innervating the semispinalis capitis muscle
The thickness of the nerves innervating the semispinalis capitis muscle was measured and recorded.
Measured: 10 months
Mapping of nerves innervating the semispinalis capitis muscle
After detailed information about the nerves innervating the semispinalis capitis muscle and the areas where they are concentrated were determined, the innervation map of the muscle was created. In this way, a muscle-nerve map was created as a guide for clinical applications.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Aug 2018
- Primary completion28 Dec 2018
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve DiseaseStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda GÖZENER CANBÜLBÜL, Medipol University
- Investigators
- Seda Gözener Canbülbül, PhD(c), Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569563
- Sponsor's protocol ID
- İMU-SEDAGOZENER-002
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robbins MS, Kuruvilla D, Blumenfeld A, Charleston L 4th, Sorrell M, Robertson CE, Grosberg BM, Bender SD, Napchan U, Ashkenazi A; Peripheral Nerve Blocks and Other Interventional Procedures Special Interest Section of the American Headache Society. Trigger point injections for headache disorders: expert consensus methodology and narrative review. Headache. 2014 Oct;54(9):1441-59. doi: 10.1111/head.12442. Epub 2014 Aug 28.
PubMed 25168295Rezasoltani A, Ahmadipoor A, Khademi-Kalantari K, Javanshir K. The sign of unilateral neck semispinalis capitis muscle atrophy in patients with chronic non-specific neck pain. J Back Musculoskelet Rehabil. 2012;25(1):67-72. doi: 10.3233/BMR-2012-0303.
PubMed 22398268Kaya B, Apaydin N, Loukas M, Tubbs RS. The topographic anatomy of the masseteric nerve: A cadaveric study with an emphasis on the effective zone of botulinum toxin A injections in masseter. J Plast Reconstr Aesthet Surg. 2014 Dec;67(12):1663-8. doi: 10.1016/j.bjps.2014.07.043. Epub 2014 Aug 7.
PubMed 25175271Takebe K, Vitti M, Basmajian JV. The functions of semispinalis capitis and splenius capitis muscles: an electromyographic study. Anat Rec. 1974 Aug;179(4):477-80. doi: 10.1002/ar.1091790407. No abstract available.
PubMed 4842939Elliott JM, O'Leary SP, Cagnie B, Durbridge G, Danneels L, Jull G. Craniocervical orientation affects muscle activation when exercising the cervical extensors in healthy subjects. Arch Phys Med Rehabil. 2010 Sep;91(9):1418-22. doi: 10.1016/j.apmr.2010.05.014.
PubMed 20801261
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innervation Characteristics and Determination of Nerve Entry Points of the Musculus Semispinalis Capitis
- ClinicalTrials.gov ID
- NCT06569563
- Acronym / sponsor ID
- İMU-SEDAGOZENER-002
- Conditions
- Peripheral Nerve Disease, Muscular Injury
- Keywords
- m. semispinalis capitis, paraspinal muscle, muscle innervation mapping, cervical spine surgery, musculoskeletal anatomy, nerve entry point, intramuscular injection, cervical dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 26 Aug 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 determine the innervation characteristics and nerve entry points of the musculus semispinalis capitis. This muscle, which is involved in the extension of the head and neck, is a large and long cervico-thoracic muscle innervated by the dorsal rami of the cervical spinal nerves. The study seeks to enhance the effectiveness of procedures like electromyography (EMG) electrode placement and botulinum toxin injections used for diagnosing and treating conditions related to head and neck pain.
Accurately identifying these nerve entry points is crucial for ensuring the safety and efficacy of treatments, particularly for conditions like cervical dystonia and headaches. While existing studies have focused on the innervation and nerve mapping of various muscles, there has been no specific research on the nerve entry points of the musculus semispinalis capitis. This study aims to provide detailed knowledge of these aspects, offering valuable guidance for interventions in this area.
Detailed description
The musculus semispinalis capitis, one of the cervical paraspinal muscles, originates from the transverse processes of the last cervical and the first six to seven thoracic vertebrae. It extends upward along both sides of the posterior midline and inserts between the superior and inferior nuchal lines on the occipital bone. This muscle is innervated by the dorsal rami of the cervical spinal nerves. As a large and long cervico-thoracic muscle, its primary function is the extension of the head and neck.
The aim of this study is to determine the innervation characteristics and nerve entry points of the musculus semispinalis capitis to enhance the effectiveness of procedures such as the placement of electromyography (EMG) electrodes for diagnostic and therapeutic purposes, as well as botulinum toxin injections used for treating conditions associated with head and neck pain.
The innervation characteristics and nerve entry points of the musculus semispinalis capitis need to be precisely identified, particularly in relation to treatments such as botulinum toxin injections for the management of spasms and pain in conditions like cervical dystonia, and for the treatment of headaches. Accurate identification of these points is crucial for ensuring safe and effective injections in this region and for understanding the anatomical variations in the area.
While there are studies in the literature focusing on the innervation characteristics and nerve entry points of various muscles, as well as nerve mapping, there has been no specific research on nerve entry point mapping for the musculus semispinalis capitis. Conducting this study will establish a detailed understanding of the innervation characteristics and nerve entry points of this muscle, providing valuable guidance for interventions in this area.
Previous studies on deep neck muscles have shown that procedures such as injections and EMG measurements have generally been performed using approximate localization methods. This study aims to use the results obtained to make these procedures more effective and less invasive.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted using 10 adult male cadavers, aged between 45 and 75 years, that had been fixed in 10% formalin solution. These cadavers were sourced from the laboratory of the Department of Anatomy at Ege University Faculty of Medicine.
Key inclusion criteria (1 listed)
- Cadavers were preserved using a 10% formalin solution.
Key exclusion criteria (5 listed)
- neck and back region curvature,
- neck flexion and extension,
- related region muscle or nerve pathology,
- fracture,
- cadavers that have undergone previous surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of nerves innervating the semispinalis capitis muscle
Time frame: 10 months
The semispinalis capitis muscle is innervated by many nerves, primarily the dorsal branches of the cervical spinal nerves. The number of branches of the dorsal branches of the cervical nerves that enter the muscle was determined and counted one by one.
The location of nerves innervating the semispinalis capitis muscle
Time frame: 10 months
In order to determine which cervical nerve branch of the semispinalis capitis muscle was concentrated in which areas of the muscle, the perpendicular distances of the points where the nerves entered the muscle to the determined landmarks were measured and recorded in mm.
The thickness of nerves innervating the semispinalis capitis muscle
Time frame: 10 months
The thickness of the nerves innervating the semispinalis capitis muscle was measured and recorded.
Mapping of nerves innervating the semispinalis capitis muscle
Time frame: 10 months
After detailed information about the nerves innervating the semispinalis capitis muscle and the areas where they are concentrated were determined, the innervation map of the muscle was created. In this way, a muscle-nerve map was created as a guide for clinical applications.
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 26 Aug 2024.
- Results publication: PubMed 25168295Robbins MS, Kuruvilla D, Blumenfeld A, Charleston L 4th, Sorrell M, Robertson CE, Grosberg BM, Bender SD, Napchan U, Ashkenazi A; Peripheral Nerve Blocks and Other Interventional Procedures Special Interest Section of the American Headache Society. Trigger point injections for headache disorders: expert consensus methodology and narrative review. Headache. 2014 Oct;54(9):1441-59. doi: 10.1111/head.12442. Epub 2014 Aug 28.
- Results publication: PubMed 22398268Rezasoltani A, Ahmadipoor A, Khademi-Kalantari K, Javanshir K. The sign of unilateral neck semispinalis capitis muscle atrophy in patients with chronic non-specific neck pain. J Back Musculoskelet Rehabil. 2012;25(1):67-72. doi: 10.3233/BMR-2012-0303.
- Results publication: PubMed 25175271Kaya B, Apaydin N, Loukas M, Tubbs RS. The topographic anatomy of the masseteric nerve: A cadaveric study with an emphasis on the effective zone of botulinum toxin A injections in masseter. J Plast Reconstr Aesthet Surg. 2014 Dec;67(12):1663-8. doi: 10.1016/j.bjps.2014.07.043. Epub 2014 Aug 7.
- Results publication: PubMed 4842939Takebe K, Vitti M, Basmajian JV. The functions of semispinalis capitis and splenius capitis muscles: an electromyographic study. Anat Rec. 1974 Aug;179(4):477-80. doi: 10.1002/ar.1091790407. No abstract available.
- Results publication: PubMed 20801261Elliott JM, O'Leary SP, Cagnie B, Durbridge G, Danneels L, Jull G. Craniocervical orientation affects muscle activation when exercising the cervical extensors in healthy subjects. Arch Phys Med Rehabil. 2010 Sep;91(9):1418-22. doi: 10.1016/j.apmr.2010.05.014.
- Individual participant dataSharing planned: No
Related trials for Peripheral Nerve Disease
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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.
Seda Gözener Canbülbül, PhD(c) principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Disease and Muscular Injury, run by Medipol University 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 1 inclusion and 5 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 26 Aug 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?
The number of nerves innervating the semispinalis capitis muscle (time frame: 10 months). 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?
On the ClinicalTrials.gov record for NCT06569563, which also lists 5 linked publications.
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 26 Aug 2024.