NCT05887349

Brief Summary

Nerve compression, disc herniation, and fracture-related factors may play a role in the etiology of chronic neck pain, or the pain may not be associated with a specific cause. In the cervical region, muscles, fascia, disc, nerve root and facet joints are the structures that carry pain. Problems related to these structures can also cause pain in the cervical region and shoulder, arm, interscapular region and craniocervical structures. The stomatognathic system is the integrity of the structures that perform the functions of chewing, swallowing and speaking. This system in the head and neck region; It consists of bones, muscles, joints, ligaments, teeth, supporting dental tissues, glands, tongue, mouth and surrounding tissues, and neuromuscular system. The relationship between the stomatognathic and craniocervical systems is demonstrated by the interaction between masticatory and cervical muscles. Wiesinger et al. examined the relationship between spinal pain and temporamandibular joint disorders in a large sample and stated that both conditions may share common risk factors or affect each other. The coexistence of cervical spine and temporomandibular joint pathologies (TMJ) is explained by the neuroanatomical convergence of nociceptive neurons receiving trigeminal and neck sensory inputs. Studies have shown that neck disability may be accompanied by jaw joint disability, masseter myofascial pain, and regional muscle tenderness. Olivio et al. He reported that the treatment of individuals with TMJ pathology should also focus on the neck region, because improvement of one may affect the other. Based on this idea, Calixtre et al. reported that they achieved positive improvements in pain and jaw functions in their study investigating the effects of cervical region mobilization and exercises on individuals with TMJ.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

December 24, 2025

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

May 23, 2023

Last Update Submit

December 18, 2025

Conditions

Keywords

chronic neck pain

Outcome Measures

Primary Outcomes (1)

  • Disability level

    Neck disability caused by neck pain was evaluated with the Neck Disability Index (NDI), which has been validated and reliable in Turkish. NDI was developed to evaluate the impact of neck pain on daily life activities (pain intensity, personal care, lifting, reading, concentration, work, driving, sleep and leisure activities) and consists of 10 sections. Each section is scored between 0 and 5 points. The total score obtained is between 0-50. Scores between 0-4 indicate no disability, scores between 5-14 indicate mild disability, scores between 15-24 indicate moderate disability, scores between 25-34 indicate severe disability, and scores above 35 indicate full disability.

    6 week

Secondary Outcomes (6)

  • Joint Range of Motion assessment

    6 week

  • Pain assessment

    6 week

  • Proprioception assessment

    6 week

  • Balance

    6 week

  • Muscle endurance

    6 week

  • +1 more secondary outcomes

Study Arms (2)

Control Group

OTHER

The patients in the control group will be given cervical stabilization exercises consisting of 3 levels and increasing difficulty. The exercises will be taught to the patients level by level by the physiotherapist for 6 weeks. The subjects will perform the exercises for a total of 6 weeks. Before each exercise session, stretching exercises will be performed on the subjects.

Other: Neck Stabilization Exercise

Intervention group

EXPERIMENTAL

The exercises to be applied to the control group for 6 weeks will be given to the intervention group in the same order and at weekly intervals. Additionally, Robacado exercises (jaw exercises) will be given to the individuals in this group.

Other: Neck Stabilization Exercise + Rocabado Exercises

Interventions

1\. Control Group exercise program (Cervical Stabilization exercises group) The patients in the control group will be given cervical stabilization exercises consisting of 3 levels and increasing difficulty. The exercises will be taught to the patients level by level by the physiotherapist for 6 weeks. The subjects will perform the exercises for a total of 6 weeks. Before each exercise session, stretching exercises will be performed on the subjects.

Control Group

2\. Intervention group exercise program (the group to which Robacado exercises will be added in addition to cervical stabilization exercises) The exercises to be applied to the control group for 6 weeks will be given to the intervention group in the same order and at weekly intervals. In addition, individuals in this group will be given Robacado exercises. Robacado exercises: 1. Resting position for the tongue: The tip of the tongue is placed on the upper palate, just behind the front teeth (resting position for the tongue). 2. When the body is in an upright position, scapular retraction and depression movements are performed without disturbing the position of the cervical region. 3. When the body is in an upright position, at C2-C7 levels, hands are clamped on the neck and cranio-cervical flexion is studied.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-65
  • Having neck pain for 3 months,
  • Being sedentary
  • Not participating in any physical therapy program in the last 6 months.

You may not qualify if:

  • Being history of previous spinal surgery or trauma,
  • Beingneurological deficit, vestibular pathology, neurological, cardiopulmonary, musculoskeletal problems affecting physical performance
  • Being any pathology in the shoulder joint, any pathology in the jaw joint, and pregnancy were determined.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (1)

  • Canli M, Ozudogru A, Alkan H, Cigdem-Karacay B. Effectiveness of Jaw Exercises Applied in Addition to Cervical Stabilization Exercises in Individuals with Chronic Neck Pain: A Randomized Controlled Trial. J Pain Res. 2026 Feb 18;19:584088. doi: 10.2147/JPR.S584088. eCollection 2026.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 2, 2023

Study Start

July 1, 2023

Primary Completion

October 9, 2023

Study Completion

October 20, 2023

Last Updated

December 24, 2025

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations