NCT03609788

Brief Summary

The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. The validation of the Turkish version of PSQ is needed, in order to measure pain sensitivity among Turkish people.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

July 25, 2018

Last Update Submit

December 12, 2018

Conditions

Keywords

pain sensitivity

Outcome Measures

Primary Outcomes (3)

  • Measurement of pain intensity in Turkish people using The Turkish version of the PSQ

    Measurement of pain intensity in Turkish people using The Turkish version of the PSQ, consisting of 17 items, describing different daily life situations with a scoring from 0(not painful) to 10 (worst pain imaginable) on a numeric rating scale. A PSQ total score is between 0-10, the higher score, the more patient's pain sensitivity.

    1 day

  • Pain Catastrophizing Scale

    This scale is used in order to assess the state of mind of patients in pain through a comprehensive evaluation instrument that encompasses the different perspectives on catastrophizing. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52.24 The higher the score, the more catastrophizing thoughts are present.

    1 day

  • Beck Anxiety Inventory

    This scale, consisting of 21 items, is a self-report measure of anxiety. Score of 0-21 shows low anxiety. Score of 22-35 shows moderate anxiety. Score of 36 and above shows potentially concerning levels of anxiety.

    1 day

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled to undergo a low back interventional procedure

You may qualify if:

  • ASA 1-2
  • adult chronic low back pain patients having pain for greater than 3 months

You may not qualify if:

  • Failed back surgery syndrome,
  • Morbid obesity (body mass index, \>40),
  • Being a non-Turkish speaker,
  • Substance abuse disorder,
  • Major psychiatric disorder (eg, severe depression, bipolar disorder, Axis II personality disorder, and schizophrenia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

May 15, 2018

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations