NCT05604027

Brief Summary

The aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life. Participants will be examined to determine the type of pain and questions will be asked to identify the effects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 10, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 10, 2022

Last Update Submit

October 27, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates)

    Neuropathic pain with PainDETECT scale, Clinical criteria and rating system for nociplastic pain affecting the musculoskeletal system nosplastic pain will be evaluated

    01.03.2023

  • Pain levels of those with nociplastic, neuropathic and nociceptive pain

    Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain

    01.03.2023

  • pain effect

    quality of life with SF-36,

    01.03.2023

  • disability,

    disability with Roland Morris Disability Questionnaire,

    01.03.2023

  • patient's feelings, thoughts, and feelings about pain and disaster.

    The Pain Catastrophizing Scale is used to assess the patient's feelings, thoughts, and feelings about pain and disaster.

    01.03.2023

Interventions

Visual Analogue ScaleDIAGNOSTIC_TEST

Clinical criteria and rating system for nociplastic pain affecting the musculoskeletal system and PainDETECT scale to determine pain type SF-36 Quality of Life Scale, Roland Morris Disability Questionnaire, Pain Catastrophizing Scale, and Visual Analog Scale to determine the effects

Also known as: Pain Catastrophizing Scale, The Roland-Morris Disability Questionnaire, Short form-36, painDETECT, Clinical criteria and rating score for nociplastic pain affecting the musculoskeletal system

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who come to the hospital for chronic low back pain

You may qualify if:

  • having chronic low back pain
  • be over 18 years old

You may not qualify if:

  • Those under the age of 18
  • Those with major psychiatric illness,
  • Those with communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Research and Training Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

November 3, 2022

Study Start

December 15, 2022

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10

Locations