NCT06946862

Brief Summary

The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2025

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment Expectation Questionnaire

    Developed by Shedden-Mora et al. (2023) (15), it is a psychological assessment tool used to measure patients' expectations about treatment before starting a treatment process. The Turkish validity and reliability study of the questionnaire was conducted by Çakır et al. (2024) (24). Validity Measurements The main items of the questionnaire, which consists of 15 main items and 6 additional questions, are structured as a scale in which the patient marks his/her expectation between 0 and 10. The questionnaire consists of treatment benefit (items 1-3), positive effect (items 4-6), negative events (items 7-9), negative effect (items 10-11), process (items 12-13) and behaviour control (items 14-15) subscales.

    Baseline

Secondary Outcomes (4)

  • Pain Beliefs Scale

    Baseline

  • Pain Self-Efficacy Questionnaire

    Baseline

  • Hospital Anxiety and Depression Scale

    Baseline

  • Visual Analogue Scale

    Baseline

Study Arms (1)

Cohort1-Chronic Neck Pain Group

Participants in this cohort are adults diagnosed with chronic neck pain lasting longer than three months. They may experience nonspecific mechanical or postural neck pain without any specific underlying pathology. Individuals with chronic neck pain of varying severity levels who meet the inclusion criteria are included in this group.

Other: no treatment, medication or intervention

Interventions

will make an observational assessment of the participants' treatment expectations. Participants will not be subjected to any treatment or intervention, only their current situation will be observed.

Cohort1-Chronic Neck Pain Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

neck pain chronic

You may qualify if:

  • Having been diagnosed with chronic neck pain by a Physical Medicine and Rehabilitation Specialist
  • Being between 18 and 80 years of age
  • Signing a consent form after receiving verbal information

You may not qualify if:

  • Presence of instability in the neck joints
  • Trauma within the last year
  • Advanced osteoporosis
  • Previous neck surgery
  • Physical therapy within the last 6 months
  • Neurological findings or radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kto Karatay Üniversitesi

Karatay, Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dosage FormsMethods

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Burcu DURSUN, Lecturer

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 27, 2025

Study Start

May 1, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

August 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data from this study will be shared upon reasonable request after the completion and publication of the study results. All data will be anonymized to ensure participant confidentiality and privacy. Data sharing will be subject to approval by the study investigators and may require a data use agreement to protect sensitive information.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be retained and available for sharing for 5 years following the completion of the study.
Access Criteria
Access to de-identified individual participant data will be granted to qualified researchers who submit a reasonable request detailing the purpose and methods of their proposed analysis. Approval from the study investigators is required prior to data release. Researchers must agree to maintain confidentiality and use the data solely for scientific research purposes. A data use agreement will be signed to ensure responsible handling of the information.

Locations