NCT05698069

Brief Summary

In order to assess the validity and reliability of the Turkish version of Pain Modulation Index, 125 volunteers with chronic pain were enrolled in the study. Test and re-test method was used to assess reliability and correlation analyses with Pain Detect, visual analog scale pain and central sensitization inventory scores were used to assess validity of the questionnaire. Turkish version of the Pain Modulation Index was found to be a valid and reliable tool for evaluating chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

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

Study Start

First participant enrolled

February 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

January 16, 2023

Last Update Submit

January 16, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reliability of the Turkish version of pain modulation index

    Internal consistency was evaluated by test retest method and calculating the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency

    15 days

  • Validity of the Turkish version of Pain Modulation Index

    Index scores were analysed for their correlation with Pain Detect and Central Sensitization Inventory scores.

    1 day

Study Arms (1)

Patients with chronic pain

Patients with non-cancer pain of more than 3 months duration.

Diagnostic Test: Pain Modulation IndexOther: Pain DetectOther: Central sensitization inventory

Interventions

Pain Modulation IndexDIAGNOSTIC_TEST

A 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes.

Patients with chronic pain

A questionnaire that was validated for the assessment of neuropathic pain

Patients with chronic pain

A questionnaire developed for the detection of central sensitization.

Patients with chronic pain

Eligibility Criteria

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

Patients who had non-cancer pain for more than 3 months duration.

You may qualify if:

  • presence of chronic non-cancer pain of more than 3 months duration

You may not qualify if:

  • Illiteracy
  • Refusal to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Hospital, Department of Physical and rehabilitation medicine

Bornova, İzmir, 355100, Turkey (Türkiye)

Location

Related Publications (1)

  • Austin PD, Asghari A, Costa DSJ, Siddall PJ. The development of a novel questionnaire assessing alterations in central pain processing in people with and without chronic pain. Scand J Pain. 2020 Apr 28;20(2):407-417. doi: 10.1515/sjpain-2019-0087.

    PMID: 31785195BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simin Hepguler, Prof

    Ege University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

February 1, 2022

Primary Completion

September 1, 2022

Study Completion

January 5, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations