Turkish Version of Pain Modulation Index

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698069
• Other study ID #: 21-7T/44
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: January 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 5, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Illiteracy

• Refusal to take part in the study

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Ege University Hospital, Department of Physical and rehabilitation medicine	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of the Turkish version of pain modulation index	Internal consistency was evaluated by test retest method and calculating the coefficient alpha (a) 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
Primary	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