NCT06566573

Brief Summary

Neck pain is a common health problem that negatively affects the quality of life of individuals of different age groups and most people experience this problem at some point in their lives. With age, changes occur in the neuromuscular functions of the cervical region that are considered normal. These changes lead to many problems such as postural disorder, decreased stabilization, loss of normal joint motion, balance disorders and decreased cervical joint position sense. When the literature was examined, the situation was observed that cervical proprioception, which is defined as joint position sense, has not been sufficiently investigated. In particular, researchers have not found any literature on how proprioceptive sensation varies according to the degree of cervical stenosis. Therefore, this study will provide a direction for the treatment of cervical region problems. The data will be discussed with appropriate statistical methods and treatment recommendations will be presented according to the results obtained.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

August 12, 2024

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual analog scale (VAS)

    Visual analog scale (VAS) will be used for pain assessment. The VAS is a one-dimensional measure of pain intensity and is frequently used in adult populations. The pain definitions used for the two endpoints on a 10 cm line are 0 for 'no pain' and 10 for 'extreme pain. Pain will be evaluated in 3 different ways: pain at the time, pain at rest and pain during activity. While assessing pain, the type and location of pain will also be questioned verbally and noted.

    through study completion, an average of 1 year

  • Assessment of Normal Joint Motion

    Normal range of motion (ROM) of the cervical region will be assessed with the Pa Crom Basic - Cervical Range Of Motion (CROM). CROM is an instrument that reliably measures cervical range of motion. The instrument is fixed to the patient's head with velcro. Patients sit in a chair and their feet are flat on the floor. The CROM dial is set to position 0 in the plane to be measured. Patients are shown how to perform the movement and are asked to actively perform this movement. Measurements are made separately for flexion, extension, right rotation, left rotation and right-left lateral flexion movements. Each movement is performed three times and passive range of motion is evaluated. The average of the test values is recorded.

    through study completion, an average of 1 year

  • Assessment of cervical proprioception

    Cervical proprioception will be assessed with the CROM instrument. To test neck proprioception, the ability to reposition the head will be examined. It is assessed in two ways: 1. Repositioning to a neutral head position (Joint Position Error - EPH) 2. Repositioning the head to a predetermined reference point (Head Repositioning Accuracy - HRPA). For CBPD, the patient is asked to reposition the head to a predetermined target position; 2-2.5 degrees deviation is normal, 3-4 degrees deviation is impaired. The patient sits upright in a chair, the CROM device is fixed to the head with velcro. In EPH, the head is held in normal position with an eye patch and deviations in CROM are recorded. In BYPD, the head is positioned in the determined position with the eye patch closed and the amount of deviation is averaged. Measurements are made in flexion, extension, right and left rotation and lateral flexion.

    through study completion, an average of 1 year

Study Arms (4)

cervical stenosis degree 0

OTHER

Pain, range of motion and proprioceptive sensations of patients with spinal stenosis grade 0 according to the Kang grading system will be evaluated on MRI.

Other: PainOther: Normal Range of MotionOther: Proprioceptive Sense

cervical stenosis degree 1

OTHER

Pain, range of motion and proprioceptive sensations of patients with spinal stenosis grade 1 according to the Kang grading system will be evaluated on MRI.

Other: PainOther: Normal Range of MotionOther: Proprioceptive Sense

cervical stenosis degree 2

OTHER

Pain, range of motion and proprioceptive sensations of patients with spinal stenosis grade 2 according to the Kang grading system will be evaluated on MRI.

Other: PainOther: Normal Range of MotionOther: Proprioceptive Sense

cervical stenosis degree 3

OTHER

Pain, range of motion and proprioceptive sensations of patients with spinal stenosis grade 3 according to the Kang grading system will be evaluated on MRI.

Other: PainOther: Normal Range of MotionOther: Proprioceptive Sense

Interventions

PainOTHER

The relationship between the degree of stenosis and pain in patients with lumbar spinal stenosis will be evaluated with a visual analogue scale.

cervical stenosis degree 0cervical stenosis degree 1cervical stenosis degree 2cervical stenosis degree 3

CROM will be used for normal range of motion (ROM) of the cervical region. Measurements will be made separately for flexion, extension, right rotation, left rotation, right and left lateral flexion.

cervical stenosis degree 0cervical stenosis degree 1cervical stenosis degree 2cervical stenosis degree 3

CROM will be used for cervical proprioception. Measurements will be made separately for flexion, extension, right rotation, left rotation, right and left lateral flexion.

cervical stenosis degree 0cervical stenosis degree 1cervical stenosis degree 2cervical stenosis degree 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 and over
  • Previously performed cervical MRI
  • Cases whose stenosis classification can be clearly determined on MRI

You may not qualify if:

  • Individuals who did not agree to participate in the study
  • Individuals undergoing cervical surgery
  • Those with pain that restricts cervical movement
  • Those diagnosed with vertigo
  • Those with sudden hearing loss
  • Having additional neurological disorders
  • Those with psychiatric and cognitive disorders that would prevent measurement in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Somatosensory DisordersConstriction, Pathologic

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

  • Betül Taspinar, Prof. Dr.

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • Ayşe Sezgi Kızılırmak Karataş, Msc. Pt.

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Onur Engin, Assist.Prof.

CONTACT

Ferruh Taspinar, Prof.Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective cross-sectional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 22, 2024

Study Start

September 15, 2024

Primary Completion

June 6, 2025

Study Completion

September 15, 2025

Last Updated

August 22, 2024

Record last verified: 2024-08