Turkish Version of Pain Modulation Index

January 16, 2023 updated by: Ece Cinar, Ege University

Reliability and Validity of the Turkish Version of the Pain Modulation Index

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.

Study Overview

Detailed Description

Pain Modulation Index is a questionnaire that was developed in English for the assessment of chronic pain for qualities consistent with central sensitization. The English version of the questionnaire was translated into Turkish by two physicians than back translated into English by two separate bilingual translators. Initially 10 volunteers were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having chronic non-cancer pain with more than 3 months duration were enrolled into the study. They answered the questions twice, 15 days apart. In addition to the Turkish version of the Pain Modulation Index, on the first visit, they were also asked to answer Pain Detect and Central Sensitization Inventory. Their answers were analysed to assess the validity and reliability of the Turkish version of Pain Modulation Index.

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Izmir
      • Bornova, Izmir, Turkey, 355100
        • Ege University Hospital, Department of Physical and rehabilitation medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Illiteracy
  • Refusal to take part in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with chronic pain
Patients with non-cancer pain of more than 3 months duration.
A 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes.
A questionnaire that was validated for the assessment of neuropathic pain
A questionnaire developed for the detection of central sensitization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of the Turkish version of pain modulation index
Time Frame: 15 days
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
Time Frame: 1 day
Index scores were analysed for their correlation with Pain Detect and Central Sensitization Inventory scores.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Simin Hepguler, Prof, Ege University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-7T/44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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