NCT06884137

Brief Summary

Although it is known that the cervical, thoracic and lumbar regions of the spine are related with each other biomechanically, there are no studies examining the relationship between cervical pain and other regions of the spine. The purpose of this study was to examine angular changes of the spine and compare it with the control group according to the state of pain in patients with neck pain. 81 patients with chronic neck pain and 40 without any pain in their neck were included in the study. Spinal Mouse device was used to evaluate thoracic and lumbar curvatures. The pain sensory was evaluated with VAS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

May 10, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2013

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2013

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 13, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

spinal curvaturesneck pain

Outcome Measures

Primary Outcomes (3)

  • Demographic data

    Demographic data (age, height, weight, body mass index (BMI) and duration of symptoms (duration of diagnosis)) of all individuals were recorded. All individuals were evaluated by the same researcher (OB) using the same test protocol.

    baseline

  • Visual Analog Scale

    The severity of pain was evaluated by VAS. The average pain intensity in the last 4 weeks was questioned. The patients were asked to mark the severity of their pain on a 10-centimeter-long line where 0 stands for no pain and 10 for intolerable pain. The results were recorded in centimeter.

    baseline

  • Thoracic and Lumbar Curvatures

    Thoracic and Lumbar Curvatures: Thoracic and lumbar region curvatures of individuals included in the study were evaluated by using Spinal Mouse (SM) (Idiag, Volkerswill, Switzerland). SM is a computer-aided electromechanical device that measures the curvatures of the spine at various postures. The locations marked on the skin were first determined by palpation and then marked with a cosmetic pen on the skin. The SM device was placed onto the 7th cervical vertebra and the recording started by pressing the button. Then the device was moved over the spinous processes of the spine from the 7th cervical vertebrae down to the 3rd sacral vertebrae where the button on the device was pressed again to finish the assessment. At a frequency of about 150 Hz, the device makes measurements along the spine at every 1.3 mm and records the data (The average length of the spine is 550 mm and the time required to measure the entire length is 2 to 4 seconds, so approximately 423 measurements are made in 3

    baseline

Study Arms (2)

the Experimental group

Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1

the control group

Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1, whereas those with any score above 5 were identified as Group 2.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who were referred to the physiotherapy program by a specialist physician (SS) and met the inclusion criteria were included in the study. Inclusion criteria were as follows: being 18-65 years old, presence of neck pain for at least 3 months, absence of any other problems related to other parts of the spine such as low back pain, absence of any neurological, rheumatical or musculoskeletal problems. Exclusion criteria were as follows: history of spinal surgery, inclusion in physiotherapy program in the last 6 months, pregnancy, risk of osteoporosis and positive test of vertebrobasilar artery. According to these criteria, 81 patients with chronic neck pain and 40 without any pain in their neck (as the control group) were included in the study. Individuals with neck pain were divided into 2 groups according to the severity of their pain. Individuals with neck pain score of 5 or less according to Visual Analogue Scale (VAS) were identified as Group 1, whereas those with any score

You may qualify if:

  • years old
  • presence of neck pain for at least 3 months
  • absence of any other problems related to other parts of the spine such as low back pain
  • absence of any neurological, rheumatical or musculoskeletal problems

You may not qualify if:

  • history of spinal surgery
  • pregnancy
  • risk of osteoporosis
  • positive test of vertebrobasilar artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck PainSpinal Curvatures

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • ÖZNUR büyükturan, professor

    Kırşehir Ahi Evran Univercity

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kırşehir Ahi Evran Univercity

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

May 10, 2013

Primary Completion

June 10, 2013

Study Completion

June 11, 2013

Last Updated

March 19, 2025

Record last verified: 2025-03