NCT06976398

Brief Summary

Chronic neck pain is one of the musculoskeletal pain problems that can cause chronic disability. It is emphasised that individuals with chronic neck pain have difficulty during different activities in their daily lives, and that this problem is a very common health problem that can lead to disability. In the case of chronic neck pain, changes in the pain threshold cause central sensitisation and individuals become more sensitive to pain stimuli. This situation can affect the processing of proprioceptive information and lead to deterioration in proprioceptive perception. This situation leads to perceptual problems in body and neck awareness. Therefore, examining the relationship between the relevant parameters is important in the rehabilitation process. In this context, the aim of the study is to examine the relationship between body awareness and pain, central sensitisation, disability and proprioception in patients with chronic non-specific neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

May 2, 2025

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Central sensitization

    It will be evaluated with the "Central Sensitization Scale". The scale is scored between 0-100 and 40 points and above is recorded as sensitive.

    Baseline

  • Pain severity

    Pain intensity will be assessed with the Numerical Pain Scale. It is scored between 0-10 and the higher the score, the greater the pain intensity.

    Baseline

  • Pain threshold

    Pain threshold will be assessed with an algometer. An increase in the applied pressure indicates a higher pain threshold.

    Baseline

  • Neck disability

    Neck disability will be evaluated with the index. It varies between 0-50 points and the higher the score, the higher the disability.

    Baseline

  • Proprioception

    Proprioception will be recorded as the degree of deviation with the CROM device. As the degree of deviation increases, proprioception worsens.

    Baseline

  • Body awareness

    Body Awareness Questionnaire (BAF) will be used. It varies between 18-126 points and as the score decreases, awareness decreases.

    Baseline

  • Neck awareness

    It will be assessed with the Fremantle Neck Awareness Questionnaire. It varies between 0-36 and as the score increases, awareness decreases.

    Baseline

Study Arms (2)

Higher sensitization

It will consist of patients who exceed the cut-off score according to the central sensitization scale score.

Normal sensitization

It will consist of patients with a central sensitization scale score lower than the cut-off score.

Eligibility Criteria

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

Patients with chronic non-specific neck pain will be included.

You may qualify if:

  • Being between the ages of 18-65
  • Being diagnosed with chronic non-specific neck pain by a doctor
  • Being willing to participate in the study

You may not qualify if:

  • Having psychological disorders, mental disorders, cancer and severe depression
  • Having a history of traumatic injury
  • Having a history of primary or metastatic spinal malignancy, spinal fracture
  • Having a neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
  • Having been diagnosed with advanced osteoporosis
  • Having a history of surgical intervention or acute infection in the cervical region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, 78050, Turkey (Türkiye)

Location

Related Publications (3)

  • van der Maas LC, Koke A, Bosscher RJ, Twisk JW, Janssen TW, Peters M. Body Awareness as an Important Target in Multidisciplinary Chronic Pain Treatment: Mediation and Subgroup Analyses. Clin J Pain. 2016 Sep;32(9):763-72. doi: 10.1097/AJP.0000000000000320.

    PMID: 26550959BACKGROUND
  • Williams DA. Phenotypic Features of Central Sensitization. J Appl Biobehav Res. 2018 Jun;23(2):e12135. doi: 10.1111/jabr.12135. Epub 2018 Jun 27.

    PMID: 30479469BACKGROUND
  • Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Musa Gunes, PhD

    Karabuk University

    STUDY DIRECTOR
  • Melek Turan

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Duygu Çataloluk

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Aydın Sinan Apaydın, PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 16, 2025

Study Start

May 8, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations