NCT05997368

Brief Summary

This study was planned to investigate the relationship between pain perceptions and pain beliefs of individuals in different age groups with chronic low back pain and symptom severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

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

August 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1 day

First QC Date

August 9, 2023

Last Update Submit

September 29, 2023

Conditions

Keywords

pain perceptionpain beliefs

Outcome Measures

Primary Outcomes (3)

  • The numeric rating scale - NRS-11

    When using the NRS-11, patients are asked to rate their pain on a scale of 0 to 10; where using integers (11 integers including zero) 0 represents "no pain" and 10 represents "worst possible pain". Based on prior studies and clinical experience of use, pain screening scores NRS-11 scores as mild (1-3) are classified as moderate (4-6) or severe (7-10).

    2 weeks

  • The centrality of pain scale - COPS)

    It is a short 10-item self-report scale designed to assess the centrality of pain. COPS scores are significantly correlated with the clinician's assessment of individual-reported pain severity, disability, mental health, quality of life, and how well the patient's pain is controlled. Each item is rated on a five-point Likert scale. It is a 10-item questionnaire (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4 and 9 are evaluated in reverse. The resulting value is the sum of all item scores. Higher scores indicate more "central" pain. The highest possible score is 50 and the lowest possible score is 10.

    2 weeks

  • The pain beliefs questionnaire - PBQ

    Two subtests of the test were created: the 8-item Organic Beliefs subtest and the 4-item Psychological Beliefs subtest. The item numbers of both subtests are listed as follows: Organic Beliefs: items 1, 2, 3, 5, 7, 8, 10, 11, Psychological Beliefs: Items 4, 6, 9, 12. The test takers are asked to indicate the most appropriate one for the participants from 6 options ranging from 1st "never" to 6th "always". The marked scores range from 1 to 6 for each item. The score collected for each subtest is calculated by taking the items in that subtest and summing them up and dividing the numbers by the number of items related to that subtest. An increase in the value calculated from the sub-dimension of the scale indicates that the belief in pain belonging to the sub-dimension is high, and a decrease in the value indicates low pain belief in the sub-dimension.

    2 weeks

Study Arms (3)

young group

Participants aged 18-39

Other: Survey1

middle-aged group

Participants aged 40-56

Other: Survey2

elderly group

Participants aged 57-79

Other: Survey3

Interventions

Survey1OTHER

As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing

young group
Survey2OTHER

As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing

middle-aged group
Survey3OTHER

As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing

elderly group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will take place in Istanbul, Turkey. Volunteers who accepted the voluntary consent form will be included in the study.

You may qualify if:

  • having low back pain for at least the past three months
  • be between the ages of 18-79.

You may not qualify if:

  • Those outside the age limit of 18-79 and illiteracy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • La Touche R, Grande-Alonso M, Arnes-Prieto P, Paris-Alemany A. How Does Self-Efficacy Influence Pain Perception, Postural Stability and Range of Motion in Individuals with Chronic Low Back Pain? Pain Physician. 2019 Jan;22(1):E1-E13.

    PMID: 30700075BACKGROUND
  • Baird AJ, Haslam RA. Exploring differences in pain beliefs within and between a large nonclinical (workplace) population and a clinical (chronic low back pain) population using the pain beliefs questionnaire. Phys Ther. 2013 Dec;93(12):1615-24. doi: 10.2522/ptj.20120429. Epub 2013 Jul 25.

    PMID: 23886843BACKGROUND
  • Pulvers K, Hood A. The role of positive traits and pain catastrophizing in pain perception. Curr Pain Headache Rep. 2013 May;17(5):330. doi: 10.1007/s11916-013-0330-2.

    PMID: 23512722BACKGROUND
  • Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.

    PMID: 12031776BACKGROUND
  • Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.

    PMID: 22225969BACKGROUND

MeSH Terms

Conditions

Chronic PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Officials

  • Mahsun EKİNCİ

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 18, 2023

Study Start

September 1, 2023

Primary Completion

September 2, 2023

Study Completion

September 25, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations