Masseter Muscle Thickness in Individuals With Chronic Neck Pain

NCT07468786 | Not Yet Recruiting

• 1 other identifier: 2026/010
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of our study is to compare the thickness of the masseter muscle, measured by ultrasound, in individuals with chronic neck pain to that of healthy individuals. The secondary objective of the study is to examine the relationships between masseter muscle thickness and pain intensity, neck disability level, pain catastrophizing level, and clinical diagnostic criteria in individuals with chronic neck pain.

Conditions

Masseter Muscle; Ultrasonographic; Chronic Neck Pain

Keywords

chronic neck pain; Ultrasonographic measurement; Masseter muscle

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic Measurement

  Masseter muscle thickness will be assessed using the B-mode ultrasound method with a 7.5-10 MHz frequency linear probe on an ALEXUS brand ultrasound device. During measurements, participants will be positioned sitting upright, with the head in a neutral position and the jaw at rest (teeth not in occlusion). Prior to measurement, participants will be instructed to avoid activities such as intense chewing or gum chewing for the last 24 hours. The measurement point will be determined as the midpoint of the line between the zygomatic arch and the mandibular angle. The linear probe will be placed parallel to the long axis of the masseter muscle fibers, perpendicular to the skin surface, and with minimal pressure applied. The ultrasound image will clearly distinguish the skin, subcutaneous tissue, and superficial and deep fascial borders of the masseter muscle.

  through of the study, average 3 months

Secondary Outcomes (4)

• Visual Analog Scale (VAS)

  through of the study, average 3 months

• Neck Disability Index - NDI

  through of the study, average 3 months

• Pain Catastrophizing Scale

  through of the study, average 3 months

• Northwick Park Neck Pain Questionnaire (NPQ)

  through of the study, average 3 months

Study Arms (2)

Chronic neck pain group

The study will include individuals aged 18-45 who have experienced neck pain for at least 3 months but do not have a diagnosed cervical pathology.

Healthy Group

The control group will also include individuals aged 18-45 with no health problems.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include individuals aged 18-45 who have experienced neck pain for at least 3 months but do not have a diagnosed cervical pathology. The control group will include individuals aged 18-45 who do not have any health problems.

You may qualify if:

• Be between the ages of 18 and 45
• Have neck pain that has persisted for at least 3 months
• Agree to participate in the study voluntarily and provide written informed consent

You may not qualify if:

• History of cervical spine surgery or severe trauma
• Diagnosis of cervical radiculopathy, myelopathy, or neurological disease
• Rheumatic, inflammatory, or systemic musculoskeletal diseases
• Diagnosed temporomandibular joint disorder (TMD)
• Diagnosis of bruxism or a pronounced habit of teeth clenching/grinding
• History of manual therapy, injection, or surgical intervention in the face, jaw, or neck region within the last 6 months
• Currently undergoing orthodontic treatment or history of orthodontic treatment within the last 6 months
• Cognitive impairment or conditions that prevent understanding and responding to questionnaires

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

Related Publications (12)

• Aslan EM, Artas A. Ultrasonographic Assessment of Masseter and Anterior Temporal Muscle Thickness and Internal Structure in Young Adult Patients With Bruxism. J Clin Ultrasound. 2025 Feb;53(2):286-293. doi: 10.1002/jcu.23866. Epub 2024 Oct 11.

  PMID: 39391995 RESULT

• Leak AM, Cooper J, Dyer S, Williams KA, Turner-Stokes L, Frank AO. The Northwick Park Neck Pain Questionnaire, devised to measure neck pain and disability. Br J Rheumatol. 1994 May;33(5):469-74. doi: 10.1093/rheumatology/33.5.469.

  PMID: 8173853 RESULT

• Ilcin N, Gurpinar B, Bayraktar D, Savci S, Cetin P, Sari I, Akkoc N. Cross-cultural adaptation and validation of the Turkish version of the pain catastrophizing scale among patients with ankylosing spondylitis. J Phys Ther Sci. 2016 Jan;28(1):298-303. doi: 10.1589/jpts.28.298. Epub 2016 Jan 30.

  PMID: 26957778 RESULT

• Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.

  PMID: 28528981 RESULT

• Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagly N. The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2008 May 15;33(11):E362-5. doi: 10.1097/BRS.0b013e31817144e1.

  PMID: 18469684 RESULT

• Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

  PMID: 1834753 RESULT

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 RESULT

• Rohila AK, Sharma VP, Shrivastav PK, Nagar A, Singh GP. An ultrasonographic evaluation of masseter muscle thickness in different dentofacial patterns. Indian J Dent Res. 2012 Nov-Dec;23(6):726-31. doi: 10.4103/0970-9290.111247.

  PMID: 23649053 RESULT

• Ariji Y, Sakuma S, Izumi M, Sasaki J, Kurita K, Ogi N, Nojiri M, Nakagawa M, Takenaka M, Katsuse S, Ariji E. Ultrasonographic features of the masseter muscle in female patients with temporomandibular disorder associated with myofascial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):337-41. doi: 10.1016/j.tripleo.2004.06.068.

  PMID: 15356473 RESULT

• Campi LB, Jordani PC, Tenan HL, Camparis CM, Goncalves DA. Painful temporomandibular disorders and central sensitization: implications for management-a pilot study. Int J Oral Maxillofac Surg. 2017 Jan;46(1):104-110. doi: 10.1016/j.ijom.2016.07.005. Epub 2016 Aug 21.

  PMID: 27553896 RESULT

• Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27.

  PMID: 20524969 RESULT

• Armijo-Olivo S, Silvestre RA, Fuentes JP, da Costa BR, Major PW, Warren S, Thie NM, Magee DJ. Patients with temporomandibular disorders have increased fatigability of the cervical extensor muscles. Clin J Pain. 2012 Jan;28(1):55-64. doi: 10.1097/AJP.0b013e31822019f2.

  PMID: 21677569 RESULT

Study Officials

• Tuğba GÖNEN, Asisst. Prof. Dr.

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba GÖNEN, Asisst. Prof. Dr.

CONTACT

505 090 58 46; tugba.badat@hku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst. Prof. Dr.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 20, 2026
• Primary Completion: April 20, 2026
• Study Completion: May 20, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)