Investigation of Related Factors in Patients With Non-Specific Neck Pain

NCT06889220 | Completed

• 1 other identifier: 2025/86
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

It has been shown that there is a complex association between neck pain, temporomandibular joint dysfunctions, and migraines, and that these conditions can be influenced by factors such as depression, physical inactivity, and health-related quality of life. Likewise, it is observed that all the factors within this complex structure can actually act as triggers, initiators, or intensifiers of each other. In recent years, with a more detailed examination of their physiological connections, a reciprocal triangular relationship has been demonstrated between temporomandibular joint (TMJ) dysfunctions, headaches-especially migraines-and neck pain. A detailed correlation of risk factors affecting neck pain-primarily temporomandibular joint involvement and headaches-in patients with neck pain will help identify underlying secondary effects and facilitate the inclusion of patient-centered, specific exercises in rehabilitation programs for these patients. Studies in the literature indicate that the relationship between neck pain, temporomandibular joint dysfunctions, and migraines has not been evaluated collectively, and the impact of factors such as depression, physical inactivity, and health-related quality of life on these conditions has not been thoroughly assessed. Therefore, this study aims to comprehensively investigate the effects of temporomandibular joint dysfunctions, migraines, and other associated factors in individuals with non-specific neck pain.

Conditions

Neck Pain

Keywords

non-specific neck pain; temporamandibular joint dysfunction; migraine; Health-related quality of life (HRQoL); Depression

Outcome Measures

Primary Outcomes (3)

• Neck Disability Index

  Neck Disability Index was first defined in 1991. It assesses disability associated with neck pain. The index consists of a total of 10 sections, evaluating pain and limitations in activities such as pain, personal care, and lifting, with scores ranging from 0 to 5 for each section. The total score ranges from a minimum of 0 to a maximum of 50. Based on the total score, the classifications are as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35 and above: Complete disability A validity and reliability study for the Turkish version is available.

  Baseline

• Migraine Disability Assessment

  The Migraine Disability Assessment Scale (MIDAS) is one of the most commonly used scales for measuring headache-related disability. It assesses migraine-related functional impairment in all activities over the past three months. The questionnaire consists of five questions: Questions 1, 3, and 5 evaluate the number of days lost due to headaches in the past three months in work or school, household chores, and leisure activities. Questions 2 and 4 assess the number of days with reduced productivity at work and in household activities due to headaches. The total score is obtained by summing the responses (number of days) for all five questions. The classification based on the total score is as follows: 0-5 points: Grade I (No or minimal disability) 6-10 points: Grade II (Mild disability) 11-20 points: Grade III (Moderate disability) 21 and above: Grade IV (Severe disability) The Turkish validity and reliability study was conducted.

  Baseline

• Helkimo Clinical Dysfunction Index

  The ındex was developed in 1974 and evaluates the overall functionality of the craniomandibular region along with TMJ function. It assesses five clinical findings, including: 1\. Mandibular range of motion 2. TMJ function 3. Pain during mandibular movements 4. TMJ pain on palpation 5. Muscle tenderness Each component is scored between 0 and 5. 1. Assesses limitations in jaw movement, including maximum mouth opening, right and left lateral movements, and forward movement. 2. component: Evaluates TMJ function by detecting deviations, sounds, and/or joint locking or blockages. 3. component: Assesses the presence of pain during specific movements. 4. component: Evaluates muscle pain in the chewing muscles. 5. component: Assesses discomfort or pain in pre-articular TMJ region through palpation. The total score is categorized as follows: 0 points: No signs or symptoms 1-4 points: Mild dysfunction 5-9 points: Moderate dysfunction 10-25 points: Severe dysfunction

  Baseline

Secondary Outcomes (3)

• Short Form - 36

  Baseline

• Beck Depression Inventory

  Baseline

• International Physical Activity Questionnaire (IPAQ)

  Baseline

Study Arms (1)

People with non-specific neck pain

People with non-specific neck pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is planned that men and women diagnosed with non-specific neck pain between the ages of 18 and 70 will participate in the study.

You may qualify if:

• Being between the ages of 18 and 70
• Having non-specific neck pain
• Experiencing migraine-related headaches

You may not qualify if:

• Having a diagnosis of cervical trauma, surgery, or disc herniation
• Having a diagnosis of abnormal range of motion in the TMJ or cervical spine, scoliosis, or kyphosis
• Having neurological impairments
• Having systemic diseases
• Having dental or oral pathological lesions, oral infections, facial paralysis, or neuropathic facial pain

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Yalova university

Yalova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Migraine Disorders; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Erdi KAYABINAR, PhD

  University of Yalova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: March 19, 2025
• Primary Completion: April 30, 2025
• Study Completion: September 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)