Turkish Version of Pain Modulation Index

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT05698069
Collaborator
(none)
125
1
11.1
11.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pain Modulation Index
  • Other: Pain Detect
  • Other: Central sensitization inventory

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 Design

Study Type:
Observational
Actual Enrollment :
125 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Reliability and Validity of the Turkish Version of the Pain Modulation Index
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Jan 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with chronic pain

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

Diagnostic Test: Pain Modulation Index
A 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes.

Other: Pain Detect
A questionnaire that was validated for the assessment of neuropathic pain

Other: Central sensitization inventory
A questionnaire developed for the detection of central sensitization.

Outcome Measures

Primary Outcome Measures

  1. Reliability of the Turkish version of pain modulation index [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

  2. Validity of the Turkish version of Pain Modulation Index [1 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • presence of chronic non-cancer pain of more than 3 months duration
Exclusion Criteria:
  • Illiteracy

  • Refusal to take part in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Hospital, Department of Physical and rehabilitation medicine Bornova Izmir Turkey 355100

Sponsors and Collaborators

  • Ege University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ece Cinar, Assistant Professor, Ege University
ClinicalTrials.gov Identifier:
NCT05698069
Other Study ID Numbers:
  • 21-7T/44
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023