NCT06569563

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 15, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

m. semispinalis capitisparaspinal musclemuscle innervation mappingcervical spine surgerymusculoskeletal anatomynerve entry pointintramuscular injectioncervical dystoniabotulinum toxin injectionsinnervation

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    10 months

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Cadavers were preserved using a 10% formalin solution.

You may not qualify if:

  • neck and back region curvature,
  • neck flexion and extension,
  • related region muscle or nerve pathology,
  • fracture,
  • cadavers that have undergone previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Kavacık, 34815, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • Rezasoltani 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.

  • Kaya 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.

  • Takebe 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.

  • Elliott 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.

MeSH Terms

Conditions

Peripheral Nervous System DiseasesTorticollis

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesDystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda Gözener Canbülbül, PhD(c)

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 26, 2024

Study Start

August 1, 2018

Primary Completion

December 28, 2018

Study Completion

June 14, 2019

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations